News

The 3-year work plan for the EU GMDP Inspectors Working Group (IWG) aligns with Network Strategy goals, emphasising supply chain integrity, product quality, enhancing inspector capacities, and the impact of new manufacturing technologies. 10 documents of the GMP Guide will be revised or newly launched.

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.

The European Medicines Agency has revised its 142-page document European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. The publication of 22 November 2021 includes the adjustments already made in October, as well as an update to paragraph 2.9 on the procedural structure of application from November. All changes to the document are marked with a corresponding date reference and concern section 2 "Steps prior to submitting the application".

The European Medicines Agency (EMA) answers frequently asked GMP/GDP questions discussed in the GMP/GDP Inspectors Working Group in its Guidance on good manufacturing practice and good distribution practice: Questions and answers. The document is continuously revised, as last in October 2022. The answers are intended to provide additional clarification to the current EU GMP and GDP regulation.

On 5 January 2021, the UK MHRA published a joint statement by the UK and Canada, which applies on an interim basis and is intended to avoid trade disruptions as a result of the Brexit. 

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

Swissmedic announces the following regarding the validity of GMP certificates:

"The GMP certificates issued by Swissmedic list the date of the underlying inspection. They do not contain a validity date. However, following the practice for GMP certificates in the EU database EudraGMDP, it is often assumed by companies or other authorities that GMP certificates based on an inspection more than 3 years ago lose their informative value about the compliance status and therefore lose their validity."

Swissmedic has further specified risk assessment measures for Nitrosamine Drug Substance-Related Impurities (NDSRI). Initially identified in 2018, nitrosamine impurities, including those in antihypertensives, prompted ongoing evaluations and measures by Swissmedic to prevent such impurities.

The European Medicines Agency (EMA) has issued a 31-page draft guideline describing the information to be included in the Summary of Product Characteristics (SmPC), labelling and package leaflet for Advanced Therapy Medicinal Products (ATMPs) that contain genetically modified cells.

As reported earlier, the European Pharmacopoeia Commission implemented five new sartan monographs in a rapid procedure at the end of February. They are scheduled to become effective already on 1 April 2021. For holders of a Certification of Suitability (CEP), this may, but does not necessarily, mean adjusting their control strategies for nitrosamine impurities. EDQM has now published supplemental information on this topic:

The European Medicines Agency (EMA) has published a 13-page Q&A including 87 questions and answers from a webinar held on the topic of integrating EudraGMDP and OMS (Organisation Management Services) into the new regulatory framework for veterinary medicines.

The PMDA (Japanese Pharmaceuticals and Medical Devices Agency) published the English translation of the revised document on remote inspections, Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products. The document describes the specific procedure for a remote inspection and how to organize, prepare and share the necessary paperwork for remote assessment by PMDA (we reported).

The EMA has published for consultation new Q&As for co-processed excipients (CoPEs) used in solid oral dosage forms. The document outlines the quality requirements for CoPEs used in solid oral dosage forms in both human and veterinary medicinal products.

The US FDA had already announced on 10 March 2020 that most foreign inspections would be postponed until April with immediate effect. Now domestic routine surveillance inspections will also be scaled back.

On 9 November 2020, Swissmedic announced to further extend the deadline for the completion of a risk evaluation for medicinal products for human use with a risk of nitrosamine formation or (cross)contamination to 31 March 2021. For biological medicinal products, the final date for the completion of an evaluation is 1 July 2020. Switzerland is thus following the EU, which announced an extension of the deadline in early October.
 

CDER released its Guidance Agenda for the year 2022. The list includes all guidances planned to be developed or finalised this year. The agenda should be seen as an indicator for the topics CDER is advancing to tackle but is not binding for the Center.

The Medical Device Coordination Group (MDCG) published an eight-page Q&A document titled Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG 2021-3) on 15 March 2021.

 The European Medicines Agency (EMA) has published a revised version 9 of its Q&A on nitrosamines for marketing authorisation holders dated 20 May 2022.

As you may have already noticed - on our website or elsewhere - we have a new company logo and also a new name.

On 30 September 2022 the MHRA informed that the use of the European Commission Decision Reliance Procedure (ECDRP) for Great Britain has been extended for another 12 months until 31 December 2023. The procedure allows a company to submit a product that has received approval from the EMA directly to the MHRA. The MHRA can then grant a license with a shorter review than normally conducted, relying on the EMA’s decision.

The competent authorities of the Russian Federation submitted a complete membership application to PIC/S in Geneva on 13 January 2021. The rapporteur(s) will be appointed in written procedure or at the next meeting of the PIC/S Committee.

The transition period until Brexit came into effect ended on 31 December 2020. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published another batch of documents for the processes that are now starting. They cover all aspects of the regulation of medicinal products and medical devices in the UK.

From 13 February, the Federal Institute for Drugs and Medical Devices (BfArM) will offer the public part of the drug information system (AMIce) in its entirety for free research.

On 26 May 2022, the European IVD Regulation (EU) 2017/746 (In vitro Device Regulation) will enter into force. This will be accompanied by various transitional periods and requirements, which have been summarised and explained by the MDCG (Medical Device Coordination Group) in a new guidance document. The 17-page Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR is aimed at manufacturers who have so far complied with the requirements of Directive 98/79/EC and may continue to market their in vitro diagnostic devices in accordance with this Directive during the transitional periods.

The EMA published for consultation an update of the guideline on the chemistry of active substances. The need for revision was identified in the report on “Lessons learnt from presence of N-nitrosamine impurities in sartan medicines” (LLE), which makes recommendations to reduce the risk of N-nitrosamines being present in human medicines and to help the European medicines regulatory network to be better prepared to deal with future cases of unexpected impurities.

The European Commission announced on 14 July 2021, that the Italian company Kiwa Cermet Italia S.P.A. has been appointed as the 21st Notified Body under the EU Medical Devices Regulation (MDR) 2017/745. It has been assigned the number 0476 in the EC's Nando database.

The MHRA has published supplementary information for international regulators: export of UK medicines and the new Windsor Framework (Northern Ireland) labelling requirements.
 

The European Borderline and Classification Working Group (BCWG), a sub-group of the Medical Device Coordination Group, has created a manual for determining whether a product is classed as a medical device under the new regulations MDR and IVDR. BCWG developed the document as part of an attempt to prevent member states from having different interpretations of the legislation.

The European Medicines Agency (EMA) has updated the annexes for the conduct of GCP inspections. First published in 2007, the annexes compile a number of seven documents.

The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, has reached Step 2b and now enters the consulation period.

The draft document contains solemly the Permitted Daily Exposure (PDE) levels for

• 2-Methyltetrahydrofuran (proposed is a PDE of 50 mg/day and a placement in Class 3 solvents)
• Cyclopentyl Methyl Ether (proposed is a PDE of 15 mg/day and a placement in Class 2 solvents)
• Tertiary Butyl Alcohol (proposed is a PDE of 35 mg/day and a placement in Class 2 solvents).

On 7 December 2023, the European Medicines Agency (EMA) published an important update on the validity of GMP certificates after COVID-19 on its Good Manufacturing Practice website:

The validity of GMP and GDP certificates, which were automatically extended to the end of 2023 under COVID-19, will be extended until 2024. Either the validity date until 2024 or the conclusion of the next on-site inspection applies, whichever comes first unless stated otherwise in the relevant document. The working group of GMP/GDP inspectors decided to continue the extension.

The US FDA announces that the spread of the Omicron variant will lead to further delays in resuming inspection activities. Originally, this step was planned for February 2022. The date is now being pushed further back. With the current developments of the Covid 19 pandemic, no new resumption date has been communicated.  

The Australian TGA has introduced temporary 'surveillance inspections' for domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals, and blood products.

For the third time in a row, the European Commission has updated its Q&A on nitrosamine impurities (we reported). Version 10 was published on 23 June 2022. Questions 5, 10 and 14 have been revised. What is new?

The Japanese Ministry of Health, Labour and Welfare (MHLW) has published an updated English translation of the Ministerial Order on the Standard of Manufacturing Control and Quality Control for Pharmaceuticals and Quasi-Pharmaceuticals.

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

The Central Drugs Standard Control Organization (CDSCO), the Ministry of Health, and the Government of India have released a 25-page document Draft Guidelines on GDP for Pharmaceutical Products. The guidelines have been developed following WHO TRS 1025 – Annex 7: Good Storage and Distribution Practices for Medical Products, with a broader focus on pharmaceutical product storage.

The European Commission (EC) launched a Biotech and Biomanufacturing Hub.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published details of what its members are doing to improve the environmental sustainability of the pharma industry. EFPIA aims to adopt innovative practices that reduce environmental impact, exceeding EU Green Deal targets under the Zero Pollution, Circular Economy, and Climate Action plans.

Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies.

The EC has published the long-awaited revised and new documents of the EU GMP Guide for consultation: Chapter 4 Documentation, Annex 11 Computerised Systems and the new Annex 22 Artificial Intelligence. Stakeholder consultations are open until 7 October on the EC website.

On 2 July 2021 the European Medicines Agency has released a revised version of the 17-pages Q&A to aid marketing authorisation holders to assess their risk for nitrosamine impurities. The revision affects questions 3 and 10:

PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.

The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.

The EMA has released the comments of the ICH guideline Q9 (R1) draft from december 2021 in late april. The document contributes principles and examples of tools for quality risk management. The document consists of 56 pages of comments from organizations such as the PDA, EFPIA and many others. In the following some excerpts:

On 08. October 2022, the Australian Therapeutic Goods Administration (TGA), published the draft guidance "Boundary and combination products - medicines, medical devices, and biologicals". The current guidance originally dates back to 2005. Since then, there have been significant changes in the regulation of therapeutic goods.

The EMA released Version 2 of its Reflection paper on GMP and Marketing Authorisation Holders on 10 January 2022. A minor text addition to the document was performed: The section on „Serialisation Data - Uploading Responsibilities" was amended with the following paragraph regarding Contract Manufacturing Organisations:

On March 9, 2020, the European Commission published version 17 of the Q&A on safety features for medicinal products. The document is updated on a regular basis (we reported).

The European Commission (EC) launched an online public consultation on cooperation with the European Medicines Agency (EMA) under the Health Technology Assessment (HTA) Regulation. The cooperation, which is outlined in a draft implementing act, includes the exchange of information between the Coordination Group on Health Technology Assessment (Member States), the Commission and the EMA.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has again revised its GMP Guide. Changes have been made to include the new EU Annex 1 on Sterile Manufacturing of Medicinal Products, which enters into force on Friday, 25 August 2023. From this same date, the PIC/S GMP Guide will also be valid.

This year's list of guidelines to be published by the CDER (Center for Drug Evaluation and Research) comprises 14 categories with a total of 89 documents. 

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in form of Annexes.

With the publication of the 54th Technical Report Series No. 1025 of the WHO, several new and revised Guidelines were adopted and recommended for use.

The FDA has issued guidance on how alternative tools can be used alongside or instead of traditional on-site inspections to assess manufacturing facilities named in pending applications. 

The aborted negotiations between Switzerland and the EU on the institutional framework agreement (we reported) are casting their shadow: new regulations are needed to ensure the safe supply of medical devices within Switzerland. However, not only Swiss manufacturers are affected. Medical device manufacturers who are not domiciled in Switzerland but who place products on the market there must also mandate an authorized representative in Switzerland.

The Medical Device Coordination Group (MDCG) issued a second revision to its surveillance guidance for medical devices. The changes align the guidance with EU regulations on transitional provisions for certain medical devices and in vitro diagnostic devices (IVDs).

The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025. Switzerland is implementing extended transitional periods in line with the EU Regulation 2024/1860.

All marketing authorisation holders for metformin-containing medicines will be asked by the EMA or the national competent authorities to test their medicines for the presence of nitrosamines before releasing them to the market. This is to be a preventive measure, as stated in the notification on the EMA website.

On 24 October 2023, the European Commission adopted steps to prevent drug shortages and increase the security of supply in the European Union.

On 26 April 2023, the European Commission published a 182-page proposal for the reform of the EU's pharmaceutical legislation and a 184-page proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with a 103-page Annex. The proposal should pave the way for the biggest reform in more than 20 years and aims to reshape the regulation of the pharmaceutical sector.

This month, the Medical Devices Coordinating Group of the European Commission, MDCG, published a 7-page guideline for notified bodies, distributors, and importers of medical devices. It should provide a basis for the certification of quality management systems (QMS) related to repackaging and relabeling processes of medical devices according to MDR and IVDR.

EMA published the revision 6 of the Appendix 1 (“Acceptable intakes (AIs) established for N-nitrosamines”) of the EMA Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (EMA/409815/2020 Rev.21).

Following a two-years drafting process the CHMP of the EMA has adopted the final guideline on quality documentation for medicinal products when used with a medical device on July 22, 2021.

On 1 August 2025, the International Council for Harmonisation (ICH) endorsed the draft version of the ICH Q3E Guideline for Extractables and Leachables and made it available for public consultation. The guideline addresses a gap in the ICH's current guidelines on impurities and comes along with a supporting document on Class 3 leachable monographs.

Concurrent with the application of the IVDR in the EU, the new Swiss regulation on in vitro diagnostic medical devices, IvDO, came into force on 26 May 2022. This is the first time since 2001 that the "third country rules" apply to IVDs in Switzerland, as they already do for all other medical devices for a year now (we reported). As of the same date, clinical trials with in vitro diagnostic medical devices are regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).

On 24 August 2022 the EMA (European Medicines Agency) published a 72-pages strong overview on the comments received as feedback on the draft of ICH Q2 Validation of analytical procedures along with a 54-pages PDF on comments made regarding the draft of ICH Q14 Analytical procedure development. The volume of the documents indicates the large number of comments that were submitted.

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.

The Medical Device Coordination Group (MDCG) has updated its guidance on standardisation for medical devices, including topics such as the European Pharmacopoeia and common specifications.

After five years of drafting, PIC/S has now published the final version of a new guideline on data integrity, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). The document has already been applied in practice on a trial basis during this time and has been modified twice.

In Mid-November, the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products (Step 4)" was finally adopted during the General Assembly of the International Council for Harmonisation (ICH). With the adoption within the ICH organization, the guidelines are considered harmonized and thus represent the current state of science and technology. A concept paper for the Guideline was first submitted in November 2018.

MedTech Europe, along with 34 national associations, published an open letter to EU Health Commissioner Stella Kyriakides on 14 September 2023.

The European Medicines Agency, EMA, has updated its regulatory and procedural guidance documents on parallel distribution as of 9 June 2021. 

The deadline of 26 May 2020 should have been the date: The European Commission's Medical Device Regulation (MDR) was supposed to come into force. Due to the Corona crisis, the European Commission is now submitting a proposal to postpone the implementation deadline.

WHO published a 31-page draft guideline, "GMP for investigational radiopharmaceutical products", in March 2021. It offers recommendations for minimum standards in the manufacture of new radiopharmaceuticals for Phase I-III clinical trials that do not have a marketing authorization (MAA).

The FDA published the second revision to the industry guidance on "Control of Nitrosamine Impurities in Human Drugs".

The World Health Organisation (WHO) has published three new draft guidelines, which are currently available for comments. In September 2020, all comments will be consolidated and reviewed. The documents will then be prepared for discussion and presented at the 55th virtual meeting of the ECSPP (WHO Expert Committee on Specifications for Pharmaceutical Preparations). It is scheduled to take place from 12 to 16 October 2020.

Every year since 2008, the International Criminal Police Organisation (INTERPOL) has carried out large-scale operations to combat the illegal trade in medicines, known as Operation Pangea.

The WHO has recently published a draft document that will be of interest to all GMP practitioners in the field of pharmaceutical quality control laboratories: WHO good practices for pharmaceutical quality control laboratories. It provides recommendations for a Quality Management System (QMS) within which analyses of pharmaceutical products should be performed by quality control laboratories. The aim is to ensure accurate and reliable analytical results.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products to include

• the revised Annex 13 on the Manufacture of Investigational Medicinal Products and
• the new Annex 16 on the Certification by the Authorised Person and Batch Release.

As part of the annual budget planning acting FDA Commissioner Janet Woodcock has addressed the problem of weaknesses in the medical devices supply chain and its overall dependence on foreign medical devices.

The International Council for Harmonisation (ICH) published a revised version of its Q9 guideline on 20 January, updating the original guideline, which is now 18 years old.

Dr. Janet Woodcock has been appointed as acting commissioner of the FDA. The previous commissioner, Dr. Stephen M. Hahn, stepped down from his role at the start of President Biden's term of office.

The new monograph on Cannabis flower (3028) will be published in Ph. Eur. Supplement 11.5 in January 2024. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.

The draft ICH Q14 guideline on analytical procedure development reached stage 2 of the ICH process on 24 March 2022. This also applies to the revised ICH Q2 (R2) guideline on the validation of analytical procedures. Both documents are now in the public consultation phase. They jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products.

On 15 February 2021, the European Commission published a 13-page document on the management of legacy devices. It clarifies questions on how these will be identified in EUDAMED or how the different Unique Device Identifiers (UDI) will be generated or assigned.  

The Assembly of the International Council for Harmonisation (ICH) has adopted the revised Q5A(R2) Guideline on the Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The guideline describes a general approach to testing and assessing the viral safety of those products and sets out the data that should be submitted in marketing authorisation applications and registration packages. These products include biotherapeutics and biological products derived from characterised cell cultures of human or animal origin (mammals, birds, insects). The term "virus" used therein does not include non-conventionally transmissible pathogens, such as mammalian prion-associated pathogens.

On 5 December 2023, the European Commission (EC) announced that it has adopted an implementing act to designate five EU reference laboratories (EURLs) for class D in vitro diagnostic medical devices (IVDs).

On 23 June 2020, the European medicines regulatory network published the outcome of a lessons learned exercise on the presence of nitrosamines in sartan medicines. This includes recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities. The report is called "Lessons learnt from presence of N-nitrosamine impurities in sartan medicines".

PIC/S has updated the following four Aide-Mémoires, which became effective on 1 January, 2021:

ICH published the revised version (Step 4) of the ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents on 22 April 2021.

On 29 April, the Food and Drug Administration (FDA) issued a final rule that will phase out its general enforcement discretion approach for laboratory developed tests (LDTs) over a four-year period.

The EMA has updated its Q&A document on N-nitrosamines as of 7 July 2023. Revision 16 comes with an amendment to Q&A 10 on the limits that apply for N-nitrosamines in medicinal products. Introduced are the Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N-nitrosamines.

The European Commission has published a new Regulation (2024/1938) providing new rules on standards of quality and safety for substances of human origin (SoHO).

The European Commission published Version 19 of the Q&A on safety features for medicinal products in late December 2021.

The European Directorate for the Quality of Medicines, EDQM, has identified another azido impurity which was tested positive in a mutagenic evaluation. So far, it has only been found in "Losartan potassium".

The Committee for Medicinal Products for Human Use (CHMP) and the CMDh (Coordination Group on Mutual Recognition Procedures and Decentralised Procedures) of the EMA extended the deadline for submission of variation applications under Step 3: "Variation of marketing authorisation for chemical medicinal products" from 26 September 2022 to 1 October 2023.

The Swissmedic Guideline on GMP-Compliance by Foreign Manufacturers was published on 1.5.2023 as version 3.0. It is addressed to the holders of marketing authorisations for medicinal products from abroad or from Switzerland if these medicinal products contain active substances from foreign manufacturers.

The 6-page amending Regulations (EU) 2023/607 with new transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the Official Journal of the European Union on 20 March 2023. It entered into force upon publication. This is intended to alleviate supply shortages of important medical devices (we reported). The regulation is binding in its entirety and directly applicable in all member states.

The European Medicines Agency (EMA) updated Appendix 1 (EMA/307633/2024 /Rev. 5) of the Nitrosamine Q&As, listing nitrosamines with established Acceptable Intake (AI) values.

Finally the date has come: as of 26 May 2021 the EU rules on medical devices (EU MDR) entered into force. Following a one year postponement due to COVID-19, this regulation is considered a big step forward to improve the safety and quality of medical devices. There are, however, still plenty of uncertainties for their manufacturers, but there is also a saying that every journey begins with single steps.

The ICH has published the 2024 Implementation Survey Report. It contains the results of a study aimed to monitor the adequacy of implementation and adherence to ICH Guidelines by regulatory authorities – continuing the assessment initiated in 2019 and repeated in 2021.

On 26 June 2025, Implementing Regulation (EU) 2025/1234 was published in the Official Journal of the EU, entering into force on 16 July 2025. It amends Implementing Regulation (EU) 2021/2226, which sets out the requirements for the electronic provision of instructions for use for medical devices. The regulations have been expanded. Switzerland is adopting these requirements immediately, initially without any additional amendments to the Swiss MepV (Medical Devices Ordinance).

Questions about the EU-UK Trade and Cooperation Agreement, which will apply from January 1, 2021, were clarified by the European Commission in a 39-page Q&A on the EU-UK Trade and Cooperation Agreement on December 24, 2020. In total, it consists of 133 pairs of questions and answers.

On 19 April 2022, the EMA published the annual report of the GMP/GDP Inspectors Working Group for the year 2021. Both, Brexit and the COVID pandemic had resulted in no reports being issued for the last three years. Instead the EMA had published a Business Continuity Plan (BCP), which was primarily based on a prioritisation of tasks.

The US FDA is proposing to amend the cGMP requirements of the Quality System Regulation for medical devices, namely the 21 CFR Parts 4 and 820. Finally, the ISO 13485:2016 should be incorporated in the US Quality System, by reference. This proposal comes four years after the US FDA announced its willingness to align the two systems.

Shortly before the end of the year, WHO published a 38-page draft with twelve chapters and two appedices on technology transfer in pharmaceutical manufacturing.

The ICH Q12 Implementation Working Group (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material is now accessible on the ICH website.

Appendix 3 of the EMA’s Nitrosamine Q&A has been updated. The Appendix deals with the enhanced Ames test conditions for N-nitrosamines.

In January 2021, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published the English translation of the document on remote inspections, "Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products".

EMA has published a draft reflection paper on linking electronic product information (ePI) from medicine packages. This paper describes components to be put in place to realise an EU-wide solution in which ePI could be easily accessed by citizens wherever they are in Europe, in their preferred language when available.

The EDQM informs that the standards cannabis flower for system suitability HRS (Herbal Reference Standard) and cannabidiol for cannabis CRS (Chemical Reference Substance) that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively.

On 30 October 2023, the World Health Organization (WHO) recognized regulatory authorities as "WHO-Listed Authorities" for the first time. WHO-Listed Authorities (WLA) are regulatory authorities that operate in accordance with international standards and fulfil the requirements based on an established benchmarking and performance evaluation process.

The EMA has updated its Q&A document on nitrosamine impurities in human medicinal products. In collaboration with the Heads of Medicines Agencies (HMA) responses to six questions were revised. Specifically, EMA updated one answer to reflect its position on the acceptability of the Ames test and another to clarify responsibilities concerning active substance master files and the certification of suitability.

As of July 2020 the EMA (European Medicines Agency) has amended the European "Joint Audit Programme, JAP". These adaptations enable regulatory authorities from third countries with an existing EU-MRA (Mutual Recognition Agreement) to participate as co-auditors in JAP audits of EEA GMP inspectorates.

Japan's PMDA (Pharmaceuticals and Medical Devices Agency) published changes to its principles for global clinical trials late last year. This revised document was published in English at the end of April 2022.

A new part of the ISO 14644 cleanroom series has been published: ISO/TR 14644-21:2023 Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques.

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) entered into force on 28 January 2022.  It modernises the existing rules on the authorisation and use of veterinary medicines in the European Union (EU). 

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence Monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. 

The EMA has published two new GDP Q&As for wholesale distributors and brokers on suspicious offers.

From 23 to 30 June 2022, Interpol conducted its 15^th globally coordinated operation PANGEA against the illegal online trade of medicines. From fake COVID-19 tests to doping substances or narcotics, the range of illegal shipments was broad.

On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).

In December 2019, the International Organization for Standardization (ISO) published the revised standard ISO 14971:2019 on application of risk management to medical devices. This standard has now been added to the list of Recognized Consensus Standards by the US FDA.

The Assembly of the International Council for Harmonisation (ICH) adopted the revised Q2(R2) Guideline on the Validation of Analytical Procedures and the new Q14 Guideline on Analytical Procedure Development. They jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products.

The Netherlands’ DEKRA Certification B.V. was named the fifth notified body under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in June 2021. Dekra Certification B.V. is also a designated notified body under the MDR.

In a statement dated 13 November 2020, EMA announces that its CHMP (Committee for Medicinal Products for Human Use) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines.

The EMA Q&A on nitrosamine impurities has been updated on 2 October 2023 and is now available as Revision 18. The update concerns Q&A 3 regarding the “call of review” and how to report steps 1 and 2 to the competent authorities. The update highlights the responsibilities of MAH(s) to control, report, and mitigate the detection of Nitrosamine impurities throughout the product life cycle, using the established procedure.

On 17 May 2021 the USFDA has released a revised version of its guidance on remote inspections. The 14-page document was originally published in August 2020 (we reported). As the pandemic still restricts most onsite inspections the FDA further clarifies general questions that came up since then.

On 1 March 2023, the final ICH Guideline Q13 on continuous manufacturing (CM) of active pharmaceutical ingredients and drug products was published by the FDA. In addition to the guidance, the agency also issued a discussion paper on AI for stakeholders' comments. With these publications, the FDA aims to facilitate the adoption of advanced manufacturing technologies for the pharmaceutical industry.

The US Food and Drug Administration (FDA) has released its Quality Management System Regulation (QMSR) final rule after years of development. It is a rework of the Quality System Regulation (QSR) – 21 CFR Part 820.

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has published its 2022 work plan with the organization’s planned actions for this year. Not only does PIC/S plan to resume its assessments for membership application but also to revise or draft new GMP guidelines.

EMA has published a concept paper on the revision of GMP Guide Part IV on ATMPs for public consultation. 

As announced by PIC/S on 23 April, 2021, the PIC/S GMP Guide has been revised. The changes will take effect on 1 May 2021. 

A first targeted consultation to the Annex 1 of the EU GMP Guide allowed about 140 companies and organizations to comment. The drafting group processed more than 6200 lines of comments. These have now been taken into account in the preparation of a second draft.

From 1 June 2023 multi-factor authentication (MFA) will be introduced for user login to CTIS (Clinical Trials Information System) for both sponsors and Member States. This should significantly increase user account security.

The EMA has published a question and answer document on the regulatory requirements for the authorisation of Cannabis-derived medicinal products in the EU and the work of the Committee for Herbal Medicinal Products (HMPC) in relation to medicinal plant monographs. This was considered useful as those involved in the production of Cannabis products often have little experience of the EU regulatory system for medicinal products.

The FDA’s Center for Devices and Radiological Health (CDRH) has published its lists with guidance documents intended to be published next year. At this stage CDRH is interested in receiving external feedback on whether the listed documents should be revised or withdrawn.

The EMA's GMDP Inspectors Working Group (GMPD IWG) has published its 2024 annual report.

The European Union has published the Delegated Regulation (EU) 2021/457 in its Official Journal on 17 March 2021. It amends the Delegated Regulation (VO) 2016/161 on safety features necessary for the packaging of medicinal products for human use. The amendment is to exempt the obligation for wholesalers to deactivate the unique identifier of medicinal products exported to the United Kingdom, being considered a third country now.

On 23 February 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that five monographs on sartans have been revised. They will be effective immediately as of 1 April 2021. 

The Therapeutic Goods Administration (TGA) has initiated a consultation phase to harmonise the basic principles for medical devices in Australia with the EU Medical Device Regulations. A comparison of the two regulatory systems revealed that the EU MDR and IVDR regulations impose additional safety and performance requirements, e.g. for clinical evidence or the information to be provided for medical devices. The keywords here are risk minimisation, risk management systems, and measures to reduce risks due to user error.

ICH has published a training presentation on ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle compiled by the Q12 Expert Working Group.

On August 12, 2020, the European Commission published version 18 of the Q&A on safety characteristics for medicinal products. The document, which has now grown to 34 pages, was thus the second update this year (we reported).
New are the questions 4.6, 5.12, 5.13 and 6.9, which are briefly summarized below: 

The European Medicines Agency (EMA) has updated guidance on GMP and GDP. The EMA has added two questions and answers on the basic requirements for active substances used as starting material in relation to third party audits.

The EMA added two good distribution practice (GDP) questions to its Q&A section on GMP/GDP topics in early January 2023. They should clarify how the GDP rules apply to brokers operating outside the European Economic Area (EEA).

The European Medicines Agency EMA updated its Q&A on nitrosamines on 30 March 2023. The update amends Q&A 22 referring to the approach to control  the presence of nitrosamines exceeding the AI during CAPA implementation. It is now indicated that no variation should be submitted to implement temporary above AI (acceptable intake) limits in specifications.

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.

As of July 2021, the European Pharmacopoeia (Ph. Eur.) now contains chapter 2.1.7 "Balances for analytical purposes". It was included as an addition to section 2.1 Apparatus and defines the requirements placed on the "balance" tool in an analytical procedure.

End of December 2019, the EMA has updated the Q&A document for marketing authorisation holders who are currently reviewing their medicines for the possible presence of nitrosamines and testing products at risk.

The Dublin-based National Standards Authority of Ireland (NSAI) was designated by the European Commission as the eleventh Notified Body under MDR and thus added to the NANDO database.

The Brazilian health regulatory agency, ANVISA, warns of counterfeit medicinal products for which import was banned immediately.
This was announced by Swissmedic, who was informed directly by ANVISA on 23 September 2020. 

The US government's Office of Information and Regulatory Affairs has issued a timeline for harmonizing, or converting, the 21 CFR 820 with the European ISO 13485 for medical devices.

On 12 April 2021, Dr Janet Woodcock, acting head of the US FDA, announced Dr Patrizia Cavazzoni's new role as director of CDER.

The EMA has published for consultation the draft guideline on risk management requirements for elemental impurities in veterinary medicinal products (VMPs). As the Ph. Eur. General Monograph 2619 on pharmaceutical preparations applies to all VMPs, risk management of elemental impurities in all VMPs in the EU market is expected.

The European Commission (EC) has proposed the Critical Medicines Act to enhance the availability of essential medicines in the EU. The regulation aims to diversify supply chains, boost EU pharmaceutical production, and improve access to critical medicines.

The WHO published a 29-page draft guideline on Good Manufacturing Practices for Medical Gases in February 2021. The reason given for this step is a sharp increase in the demand for medical gases, particularly oxygen used to provide respiratory care to covid patients.

The International Pharmaceutical Excipients Council (IPEC) Federation has released an update of its position paper advocating for independent third party audits and certification programs. The position paper was first published in September 2015.

The MHRA is further extending its regulatory network. A new regulatory recognition framework for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. It should be in place by the first quarter of 2024.

On 23 February, the German Bundestag approved the government's bill on the "controlled use of cannabis". The law allows adults to possess up to 50 grams of cannabis in private and up to 25 grams in public.

DEKRA Certification UK Ltd has become the first organisation after Brexit to complete the new designation process that any potential organisation must go through to become approved to certify medical devices in the UK. With this step taken it is now designated as a UK approved body to undertake assessments for general medical devices (known as Part II designation) and has joined the three current UK Approved Bodies BSI Assurance UK Ltd, SGS United Kingdom Ltd, and UL International (UK) Ltd. These three bodies had been approved before Brexit.

On 1 September 2020, the British MHRA (Medicines and Healthcare products Regulatory Agency) published numerous guidelines explaining how medicinal products, active ingredients, medical devices or clinical trials are to be regulated after the brexit transition period ends on 1 January 2021.

During the press conference of the PDA/FDA Joint Regulatory Conference 2024, PDA (Parenteral Drug Association) announced interesting new publications and the formation of the new D/A/CH Chapter to support local members.

In February 2025, EMA's CHMP adopted a positive opinion approving changes to the manufacturing process for Champix, a smoking cessation medicine.

The Q2(R2)/Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revised the ICH Q2(R1) Guideline on Validation of Analytical Procedures. The ICH Q2(R2) revised Guideline and the Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. A Step 4 introductory training presentation has now been developed by the Q2(R2)/Q14 Expert Working Group.

This year's Center for Drug Evaluation and Research (CDER) list of guidance documents scheduled for publication includes 18 categories with a total of 105 documents.

EMA has updated its FAQ document on the European Shortages Monitoring Platform (ESMP), addressing six new questions – five related to data submission and reporting. 

The European Commission has released a 10-page Q&A document on the practical aspects of the new transitional provisions for certain medical devices and iv-medical devices. These were laid down in the Regulation (EU) 2023/607, which was published on 15 March 2023 (we reported).

As the Indian Directorate General of Foreign Trade announced on 3 March 2020, the export of 26 active ingredients and medicinal products will be severely restricted until further notice due to the global spread of the coronavirus.

The US FDA, Health Canada, and the British regulatory agency MHRA have jointly released 10 guiding principles to support the development of Good Machine Learning Practice (GMLP). As a basic framework it should help to promote safe, effective, and high-quality medical devices, while using AI (artificial intelligence) and ML (machine learning).

During this year‘s Regulatory Conference, the Parental Drug Association (PDA) announced that a comprehensive AI glossary is available on its website.

As the PIC/S announced on 30 November 2020, the Brazilian National Health Authority "Agência Nacional de Vigilância Sanitária" (ANVISA) has become the 54th member of PIC/S. 

The European Medicines Agency (EMA) plans to establish clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides. This week, EMA published new concept papers, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.

On 11 December, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced a validity extension of GMP and GDP certificates.

The European Commission published a Notice this January dealing with the legal framework for medicinal products marketed in Northern Ireland. On 9 March 2021, the UK MHRA, for its part, followed up and also addressed the issue. 

Swissmedic has updated its medicinal products' portal, introducing a new process for ordering GxP certificates and granting direct access to all pre-registered company administrators. However, Swissmedic acknowledged the absence of a new onboarding process for companies or administrators as a known issue.

On 14 January 2020, the EMA published a draft Reflection Paper on the GMP-related obligations of marketing authorisation holders (MAHs). In general, these responsibilities relate to outsourcing and technical agreements. However, they are spread over the different chapters and annexes of the EU GMP Guideline and are also quite numerous. The aim of the reflection paper now is to clarify in a single document what the different responsibilities are and what they mean for MAHs at a practical level. It also addresses the legal provisions in European Directives and other Directives that relate to GMP and also affect marketing authorisation holders.

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.

The EDQM has released an updated version of the guideline “How to Read a CEP”, offering clear explanations of the information contained in Certificates of Suitability (CEPs) to European Pharmacopoeia monographs.

In late June 2023, the European Medicines Agency updated two Q&A documents on centralised marketing authorization procedures. With this, EMA provides scientific and regulatory advice to pharmaceutical companies on the regulatory process for the European drug approval. Q&As relevant before, during, and after the approval of medicines for the European market have been updated or newly added.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published the 21st edition of the Guideline for the Preparation, Use, and Quality Assurance of Blood Components earlier this month. As a compendium of widely accepted, harmonised European technical standards the guide should provide safety, efficacy, and quality requirements for the preparation, use, and quality control of blood components in Europe and beyond.

The Brazilian health regulatory authority, ANVISA, has decided to consider evaluation reports from international regulatory bodies in their decision-making process.

To a new one! The EMA Q&A on nitrosamine impurities has been updated again after only three weeks and is now available as Revision 17 corr. The update concerns Q&As 20, 21 and 22 and a correction of the table including the potency score calculation in example 4 for N-nitroso-l-nebivolol. It had been omitted in the previously revised version 17 and has now been re-introduced.

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the top 10 deficiencies identified in 2023 following the initial evaluation of new applications for Certificates of Suitability (CEP).

On 12 May 2022, the EMA published the final guideline on quality of herbal medicinal products/traditional herbal medicinal products. The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) originally started working on the revision of the guideline in 2015. Revision 3 which now represents the final guidance was adopted in January 2022.

An update of the Appendix 1 (“Acceptable intakes established for N-nitrosamines”) of the Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products has just been published by the EMA.

This month the US FDA issued a 28-page new guidance for immediate implementation, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). It provides drug manufacturers and applicants with a framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA. Ways to predict the mutagenic and carcinogenic risk of NDSRIs and acceptable intake (AI) limits are outlined.

The Chinese drug authority NMPA has published its long-awaited draft annex to the Chinese GMP for sterile drugs for public review and comment. There is close alignment with the tripartite WHO/EU/PICs GMP Annex that was published in 2022.

Today, the European Commission published the revised Chapter 1, Pharmaceutical Quality System, of the EU GMP Guide. The public consultation phase closes on December 3, 2025.

The EMA has published 14 questions and answers for biological products on its website. The CHMP Biologics Working Party developed the page that provides their agreed positions on issues that typically arise from discussions or correspondence during assessment procedures of biological human medicinal products.

The Access Consortium is a collaborative initiative of like-minded, medium-sized regulators from Australia, Canada, Singapore, Switzerland, and the United Kingdom.

The European medicines regulatory network has announced the automatically applied extension of the validity of GMP and GDP certificates for sites in the EEA (European Economic Area) until the end of 2022, unless there are restrictions on the validity period stated in the clarifying remarks of the certificate. This extension also applies to time-limited manufacturing and import and wholesale authorisations.

The European Council has adopted its negotiating position on the major reform of EU pharmaceutical laws, the 'Pharma Package', and is now ready to start talks with the European Parliament.

In May 2020, the WHO published the following three drafts for commentary: 

Swissmedic has updated its guidance on Good Manufacturing Practice (GMP) compliance for foreign manufacturers, clarifying documentation requirements for various application types (e.g., new authorizations, type IA/IB/II changes for human and veterinary medicines).

On 4 July 2022 the European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices considered to be high-risk. These relevant harmonised standards had already been partially introduced in the repealed Directive 98/97/EC. Now the specifications have been updated and adapted to the state of the art.

In a press release the EMA informs pharmaceutical and medical device manufacturers about the withdrawal of Great Britain from the EU on 31 January 2020. What are the current developments?

EMA published Revision 3 of the Q&A on the Protocol on Ireland and Northern Ireland on 5 March 2021. The 11-page document contains 28 pairs of questions and answers. It is updated regularly and will be of interest to all GMP professionals who have business relationships with companies in Northern Ireland.

One thing is certain: The FDA’s utilizing remote regulatory assessment is here to stay and remain a regular tool to support onsite inspections. This was addressed by FDA Commissioner Robert Califf and his associate Commissioner for Regulatory Affairs, Judith McMeekin, in a statement released end of July.

As of 31 January 2022, the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) entered into force, repealing the Clinical Trial Directive (EC) No. 2001/20/EC. This step is meant to facilitate the daily business of sponsors in the EU immensely, when it comes to filing clinical trial applications. The new Clinical Trials Information System (CTIS) serves as a single-entry point for submission and assessment of clinical trial data for all EU and EEA countries and has gone live.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the online-only European Pharmacopoeia (Ph. Eur.) in June 2025, transitioning to a more environmentally friendly format. The new platform will enhance user experience with a modern interface and improved search tools.

As the EMA announced on 30 April 2020, all ranitidine medicines in the EU are to be taken off the market. 

The EU GMP Annex 21: Importation of medicinal products has finally been published on February 21, 2022, and will enter into force on August 21, 2022. The 6-page new Annex summarises the GMP requirements for Manufacturing Import Authorization (MIA) holders of human, investigational, and veterinary medicinal products from outside the EU/EEA. Medicinal products entering the EU/EEA for export only and are neither processed in any way nor released for placing on the EU/EEA market, are not covered by this Annex.

The European Commission (EC) has published a call for evidence on the medical device and in vitro diagnostic regulations (MDR/IVDR). The initiative aims to simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate. The overall structure of the current regulatory framework will be maintained.

The Australian authority TGA has published a revision of the guideline on licenses and certification "Guidance on Australian manufacturing licenses and overseas good manufacturing practice (GMP) certification" on 1 December 2021. The revision relates to an expansion of possible inspection types as well as the scheduling of the inspection for licensing procedures.

The US FDA’s CDER revised the Manual of Policies and Procedures (MAPP) on managing surveillance inspections based on its Site Selection Model. The CDER staff uses this model to prioritise manufacturing sites for national and international routine quality-related cGMP surveillance inspections.

The European Medicines Agency (EMA) has launched an initiative to collaborate with non-EU authorities and WHO to drive the evaluation processes for COVID-19 vaccines and therapeutics.

The new European standard EN 17141:2020 has been issued on 12 August 2020 and will replace the DIN EN ISO 14698 (Parts 1 and 2) of the year 2003, which no longer reflects the state of the art.

On 20 July 2020, EMA published the final 10-page Guideline on the quality of water for pharmaceutical use.
The date of entry into force will be 1 February 2021.

The European Commission's Medical Device Coordination Group (MDCG) published a definition on ‘hybrid audits’ in early December.

The document gives notified bodies some flexibility regarding the duration of physical presence during audits under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR).

The Association of German Engineers (VDI) has updated and published for comment its cleanroom standards, VDI 2083 Part 4.1 and Part 4.2. Part 4.1 covers the planning, construction, and initial commissioning of cleanrooms, and Part 4.2 covers the energy efficiency of cleanrooms.

Swissmedic announced on 23 January that companies with a valid manufacturing licence for the manufacture of medicinal products can apply for a GMP certificate. The certificates do not contain a validity date, but the date of the GMP inspection.

In November 2020, the WHO published a first draft on GMP for research and development facilities.

The long-awaited final version of the new EU Annex 1 "Manufacture of Sterile Medicinal Products" was published on 25 August 2022. The deadline for entry into force is 25 August 2023. Regarding section 8.123 on freeze-drying and product transfer, the deadline for entry into force is two years from now and will thus become mandatory on 25 August 2024.

The EMA has published an updated Q&A on the impact of MRA between the EU and the US. Since last year, the US has confirmed the capability of 4 additional EU Member States for veterinary product inspections.

The World Health Organisation (WHO) announced that Senegal had became the 7th country and Rwanda the 8th country to achieve the status of a stable, well-functioning regulatory authority for the regulation of medicines in Africa.

On 14 October 2021, the European Commission has proposed a “progressive roll-out” of the upcoming In Vitro Diagnostic Medical Devices Regulation, IVDR. The reason given for that is to prevent disruption in the supply of those essential healthcare products that fall under it, as well as a serious shortage of notified body capacity. The IVDR was planned to apply as of 26 May 2022.

The European Commission published the 4-page draft version of the new Annex 21: Importation of medicinal products on 20 March 2020. Apart from the main Chapters and Annexes of the EU GMP Guide, it has become necessary to establish specific guidelines for the activity of importing medicinal products.

The U.S. FDA announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. 

The FDA’s Office of Regulatory Affairs (ORA), responsible for inspections and other field activities, has released its summary on inspectional observations listed on FDA Forms 483 from October 2020 to September 2021.

On 22 March, the German Cannabis Law was passed by the Bundesrat. The law will therefore come into force on 1 April as planned.

In July 2021, EDQM published a revised version of the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" (PA/PHCEP (09) 108). This guidance includes the current requirements for how an application for Certificates of Suitability must be conducted in eCTD format.

On 24 May 2023, the European Commission provided a downloadable template that notified bodies can use under Regulation (EU) 2023/607.

The Australian regulatory authority for therapeutic goods TGA has updated its19-pages quality requirements for medical cannabis products. These are now in line with TGO 93 and refer to

• any medicinal cannabis product imported into or supplied in Australia
• cannabis plant used in the manufacture of medicinal cannabis products e.g., as an ingredient or as a starting material for an extract used as an ingredient
• any other ingredients used in the manufacture of medicinal cannabis products, such as excipients
• steps and procedures carried out in the manufacture of medicinal cannabis product.

The European Commission has tasked its ad-hoc working group (WG) on pharmaceuticals in the environment with drafting a concept paper on the regulatory framework. The WG formed in 2020, is joined by the following Member States: Austria, The Czech Republic, Finland, France, Germany, Ireland, The Netherlands, Slovenia, Spain, Sweden, Poland, Romania, Italy and the European Medicines Agency (EMA).

The European Commission, the EMA and the European Network of Medicines Regulatory Authorities have published the third version of the Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic on July 1, 2020. The document has meanwhile grown from originally 7 to now 23 pages and intends to serve pharmaceutical companies as a guide on current adjustments to the regulatory framework due to COVID-19.

As we already reported in December 2022, the use of the Clinical Trials Information System (CTIS) is now obligatory in the EU.

On 27 July 2021, ICH published the anticipated draft of its Q13 Guideline on Continuous Manufacturing of Drug Substances & Drug Products. In Stage 2 of the ICH process the 44-page document has thus been released for public commentation.

The guideline is intended to provide "scientific and legal considerations for the design, implementation, operation and lifecycle management of continuous manufacturing (CM)".

The European Commission (EC) designated the German company TÜV Rheinland as a Notified Body under the In Vitro Diagnostics (IVDR) Regulation on 1 December 2020.

The European Commission has revised and restructured the Compilation of Community Procedures on Inspections and Exchange of Information. In addition to new content and editorial adjustments, the 295-page document has been divided into a Part I including procedural topics and a Part II containing interpretation documents and templates. The documents were last updated in 2014.

On 8 April 2020, the Medical Device Coordination Group (MDCG) published a five-page guideline on the conduct of audits by Notified Bodies to be applied during the COVID 19 pandemic. 

As announced by TÜV Süd Product Service GmbH on 17 June 2020, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) designated the company as the fourth Notified Body according to the In Vitro Diagnostic Regulation (IVDR).

The Drug Regulatory Authority of Pakistan (DRAP) issued a Rapid Alert on 22 August 2024 regarding counterfeit batches of Propylene Glycol. The batches are tagged with Dow Chemical labels, and some are declared to be from 'Dow Europe GmbH, Made in Germany'.

PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents will enter into force on 1 January 2025.

After a one-year postponement period, the European In Vitro Diagnostic Medical Devices Regulation (IVDR) finally came into force on 26 May 2022 and follows the Medical Device Regulation (MDR), which has been in force for one year.

The European Commission (EC) has published a new version 21 of its Q&As on safety features for medicinal products for human use. Four new questions have been added.

On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the designation of two new UK Approved Bodies (UKAB) to increase the capacity to certify the performance and safety of medical devices.

As announced by the European Commission on 18 February 2021, the Italian Istituto Superiore di Sanità (ISS) has been designated as the 19. Notified Body under the EU Medical Devices Regulation (MDR) 2017/745.

In order to address the current exceptional circumstances, the UK regulatory authority MHRA has opted for a temporary flexibility on good manufacturing practice (GMP). The authority considers these steps necessary to meet the current  supply needs of medicines in the UK. In this context, the GDP requirements for wholesalers have already been relaxed and the discretionary scope for QPs has also been extended.

The US Food and Drug Administration (FDA) presented a "scaled-down" plan for collecting quality metrics from drug manufacturers end of March. The docket is an attempt to reactivate previously paused efforts to collect manufacturing quality metrics data. The primary aim of the program is to mitigate potential drug shortages and promote improved quality management in the pharmaceutical industry.

The European Court of Justice (ECJ) has ruled that harmonised technical standards are part of EU law and should therefore be freely accessible to EU citizens (Judgment of 05.03.2024, ref. C-588/21 P).

As announced on 26 January 2021, the Jordan Food & Drug Administration (JFDA) has submitted a complete application for membership to the PIC/S.

Brasil‘s Anvisa has launched a new tool, a dashboard, which allows you to consult the list of active ingredients in medicinal products for which registration applications are being assessed by the agency.

The International Council for Harmonisation (ICH) held its Assembly meeting on 13–14 May 2025 in Madrid, Spain, alongside 11 Working Groups and prior meetings of the Management and MedDRA Steering Committees.

The FDA has issued final guidance clarifying "remanufacturing" for reusable medical devices needing maintenace or repair, aiming for consistency and better understanding of federal laws.

The UK MHRA has released guidance on the labelling and packaging of medicinal products following the Windsor Framework. It introduces a “UK Only” label and the take over of the MHRA to approve and license medicines across the UK. Furthermore, the application of the EU Falsified Medicines Directive (FMD) in Northern Ireland will no longer apply. The Windsor Framework covers the supply of medicines into Northern Ireland and will replace the current Brexit conditions.

The ACSS Consortium, a joint initiative of the regulatory authorities of Australia (TGA), Canada (HC), Singapore (HSA) and Switzerland (Swissmedic) announces a new membership: the British MHRA. Following as short observatory role, the MHRA will officially start to work with the consortium partners on January 1, 2021.Along with this, the group has changed its name to accommodate the new partner, and will be known as the "Access Consortium". The new name reflects the group’s key aim of providing patients with timely ‘access’ to high quality, safe and effective therapeutic products across the five countries.

The World Health Organization (WHO) has published the 10^th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volume 2, Good manufacturing practices (GMP) and inspection".

The ICH has published the updated Q9(R1) Annex 1: Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM).

On 17 May 2023, EMA published recommendations for industry on the for marketing authorisation holders, wholesalers, distributors, and manufacturers to minimise the occurrence of medicine shortages and their impact.

Swissmedic clarified on 20 November 2020 that GMP certificates issued after routine inspections in 2017 or 2018 are valid until 2021 or until the conduct of the next routine inspection.  

The U.S. Food and Drug Administration (FDA) has launched Elsa, a generative AI tool aimed at enhancing the productivity of its employees, from scientists to investigators.

Given the changed situation regarding COVID-19 and the differing measures introduced by the various cantons in Switzerland, Swissmedic has decided to adapt the way inspections in the healthcare field are carried out. As of 3 November 2020, inspections will only be performed after prior clarification of possible COVID-19-related capacity problems.

The EMA (European Medicines Agency) announces that the deadline for the completion of a risk assessment for all chemically defined human medicinal products that bear the risk of nitrosamine formation or (cross)contamination will be extended until 31 March 2021. For biological medicinal products, the final date for completion of a risk assessment will be 1 July 2020.

On 25 September 2023, Swissmedic expanded a list of frequently asked questions for marketing authorisation holders submitting adverse drug reaction (ADR) reports under the authority's pharmacovigilance program. The Swiss surveillance authority is thereby preparing manufacturers in its area of application for the additional documentation requirements in individual case reports, which will be mandatory from 1 January 2024.

The US FDA has revised its 16-year-old guidance on how to investigate out-of-specification (OOS) test results in laboratories. The document includes all necessary steps to be taken when investigating OOS test results. It also considers the responsibilities of the analyst and the laboratory supervisor in case of OOS results being identified, along with additional testing steps and a final evaluation of all results.

The Australian Therapeutic Goods Administration (TGA) has opened a consultation on 16 June 2023 on the risk classification of medical devices containing certain animal, microbial or recombinant materials.

On 9 November 2023, the EMA published a 5-page document with three Q&As on the extended interpretation of Annex 12 of the EU GMP Guideline "Manufacture of medicinal products using ionising radiation" for X-ray sterilisation processes. The questions relate to the use of X-ray sterilisation for single-use systems (SUS) in pharmaceutical manufacturing. These processes are becoming increasingly established.

The European Commission (EC) has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

The International Coalition of Medicines Regulatory Authorities (ICMRA) is announcing the initiation of two regulatory collaboration pilots addressing facility inspections and Chemistry and Manufacturing Controls (CMC) and Post-Approval Change (PAC) submission assessments and related regulatory actions.

The European Medicines Agency (EMA) has adopted the ICH guidance on the continuous manufacturing of drug substances and drug products which marks the Step 5 process of document adoption by the Regulatory Members of the ICH Assembly. The document was released on 6 January 2023 and will come into effect on 10 July 2023.

As communicated by the EMA, the EUDRAGMDP database will be „merged“ with EMA’s Organisation Management Service (OMS). This is an important change to be aware of for all manufacturers, importers and distributors of human and veterinary medicines whose information is recorded in EUDRAGMDP.

The FDA has finalized two guidance documents to help ensure that prescription drugs are identified and traced properly while moving through the supply chain. The documents address how to comply with the DSCSA (Drug Supply Chain Security Act) requirements.

The Australian Therapeutic Goods Administration (TGA) has suspended all foreign GMP inspections and QMS (Quality Management System) audits until further notice.

Robert M. Califf, M.D., was sworn in as new Commissioner of the Food and Drugs Administration on February 17, 2022. He has previously served as Commissioner from February 2016 to January 2017, during President Obama’s final year in office. 

The ICH Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management was adopted by the CHMP (European Committee for Medicinal Products for Human Use) in January 2020. On March 4,  the EMA (European Medicines Agency) published a two page note on the implementation of ICH Q12. It addresses the fact that there are conceptual differences between ICH Q12 and the EU legal framework. Therefore, a 1:1 application in the EU is not possible without further ado.

ICH has published the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM). These materials, include a Q9(R1) Introduction Presentation replacing 5 presentations in the current ICH Q9 Briefing Pack and updated ICH Q8/Q9/Q10 Training Material which replaces 12 presentations developed in 2006-2010.

Emer Cooke from Ireland began her mandate as Executive Director of the EMA on November 16, 2020. On June 25, 2020 she was the first woman nominated for this position (we reported).

Swissmedic has published a new Technical Interpretation based on the guidelines of Good Distribution Practice (GDP). It defines the minimum requirements for wholesalers handling medicinal products returned by retailers, particularly with regard to the time limits that must be observed between delivery and return of the medicinal products.

EMA releases templates to assist marketing authorisation holders (MAHs) in creating plans to prevent and mitigate shortages. The EMA is urging MAHs in the EU/EEA Area to develop a plan to prevent shortages and minimise the likelihood of shortages for their marketed medicines.

The draft for the ICH Q3D(R2) Guideline for Elemental Impurities has reached Step 2 on September 25, 2020 and thus the consultation phase. The draft guideline includes, amongst others, corrected PDE values for gold, silver and nickel and a new appendix for impurities that are applied cutaneously or transcutaneously.  

The ICH has published the ICH Q13 IWG "Continuous Manufacturing of Drug Substances and Drug Products" Modules 1–12 video training material.

EMA published the document "GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances" in February 2021.

The EMA has published for consultation a reflection paper on the qualification of non-mutagenic impurities (NMI).

The ICH Q3C “Guideline for Residual Solvents” has undergone revision to become finalised as version R9 using the Minor Revision Procedure. This revised document was published on 24 January 2024 and reached Step 4 of the ICH Process, which is the adoption of a harmonised guideline.

The EMA has revised the Q&As on good manufacturing and distribution practices (GMPs/GDPs). A new question and answer on the documentation of supply chain traceability has been added to the section about EU GMP Guide Annex 16 certification by a qualified person and batch release.

The ICH published a press release on June 20, regarding a face-to-face meeting on June 12 and 13, 2023, in Vancouver, Canada. Meetings of 14 working groups, the ICH Management Committee and the MedDRA Management Committee were also held during that time.

The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management (PQKM) collaborative pilots have been extended until the end of 2025. ICMRA is actively seeking new applications for collaborative review by multiple global regulators. 

On 23 July 2021, EMA has finalized its reflection paper on GMP-related responsibilities and marketing authorisation holder companies (MAHs). As various tasks are spread over different chapters and annexes of the EU GMP Guide and various directives, the paper now summarizes them in a single 29-page document. This is to provide clarity on which responsibilities are to be considered and what they signify for MAHs at a practical level.

The ICH published a 29-page presentation on the revision of ICH Q9 on 14 March 2023. The guideline on quality risk management was published in January 2023 (we reported) and will come into force in July 2023.

In the second week of January, the European Commission (EC) published a list of members appointed to the MDR and IVDR expert panels. On 10 September 2019, the 12 expert panels were designated by the Commission Implementing Decision (EU) 2019/1396.

The Mutual Recognition Agreement between Switzerland and the USA signed in January entered into force on 27 July 2023. As already reported, the MRA allows the FDA and the Swissmedic to share and use each other's GMP inspectional findings regarding medicinal products.

On 26 November 2021, the European Commission issued the Implementing Regulation (EU) 2021/2078 on the European Database for Medical Devices, Eudamed. The document provides a legally binding framework for all users.

The Pharmacopoeial Discussion Group (PDG) signed off on the harmonised general chapter “Elemental Impurities (G-07)” on 19 June 2024. The PDG, which includes the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP), worked on this chapter to align elemental impurity requirements across regions based on the ICH Q3D Guideline.

The guideline on Good Agricultural and Collection Practice (GACP) for herbal starting materials has been in place since 2006 to ensure consistent quality of herbal substances. The newly released Revision 1 updates the document to current standards, reflecting developments over the past decade such as the growing use of indoor cultivation technologies and published legal interpretations. In addition, Annex 1 introduces specific requirements for indoor cultivation practices.

An update of the EMA's Appendix 1 to the questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products has just been published (EMA/72902/2024 /Rev. 3).

The European Medicines Agency (EMA) has published a revised version 12 of its Q&A on nitrosamines for marketing authorisation holders dated 10 October 2022. The revision includes an update of Q&A 10 on the limits for nitrosamines in medicinal products and introduces a new Q&A 21 on the approach to control presence of nitrosamine while the AI is being established.

On 17 September 2021, the US FDA released the revised Q&A Guidance on Biosimilar Development and the BPCI Act. The 28-page document provides rapid, development-related guidance to biosimilar and interchangeable biosimilar sponsors and other stakeholders on discrete issues.

On 1 July 2023, the new "Nitrosamines Specialist Group" of the Swiss regulatory agency Swissmedic started its work, as announced in May. The group is divided into a coordination office and a centre of expertise for all issues regarding nitrosamines.

The European Commission adopted two implementing decisions on the sterilisation of medical devices. These decisions were made in accordance with the regulations governing medical devices and in vitro diagnostics (IVDs) in the EU.

Regulation (EU) 2024/1860 amending the MDR and the IVDR was published in the Official Journal of the EU on 9 July and entered into force immediately.

The EDQM pre-published the revised monograph on Propylene glycol (0430) adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The revision took part as a response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol (DEG) contamination in several medicinal products in Africa and Asia and confirmed cases of propylene glycol adulterated with EG with over 190 fatalities in Indonesia.

On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) announced that they were phasing out the extraordinary regulatory flexibilities for medicines that were effective during the COVID-19 pandemic.

The EDQM informs that the 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2023, and to follow the instructions that the EDQM provides.

Finally, the long-awaited nomination for the next FDA commissioner is here. President Biden has nominated Dr. Robert Califf, a clinical trial expert and founding director of the Duke Clinical Research Institute.

The GMP/GDP Inspectors Working Group has amended their FAQs on GDP. Two new questions deal with the possibility and conditions for remote activities of the resposible person (RP) for GDP.

The CMDh (EMA's Coordination Group for Mutual Recognition and Decentralized Procedures) has approached one of the EMA's Safety Working Parties (SWPs) with the following two questions regarding chlorobutanol...

On 22 February 2021, the European Medicines Agency (EMA) published a 14-page implementation plan dealing with the prevention of nitrosamine impurities. It is based on the results of the CHMP's scientific review of the subject.   

The Indian Health Ministry has introduced revised rules under Schedule M of the Drugs and Cosmetics Rules, aimed at ensuring robust quality control for pharmaceutical and biopharmaceutical products. Schedule M outlines Good Manufacturing Practices (GMP) for pharmaceutical products.

Centrally authorised medicinal products placed on the market in one European Member State may be marketed under the same name in any other Member State by a distributor independent of the marketing authorisation holder. This process of parallel distribution is supervised by the EMA.

The European Medicines Agency (EMA) has published four new questions and answers around Remote Batch Certification/Confirmation of a Qualified Person (QP). One Q&A deals with the residence specification for a QP. They apply to EU/EEA QP certification or QP confirmation, as described in EU GMP, and specifically in Annex 16. It applies to the manufacture and importation of human and veterinary medicinal products and investigational medicinal products.

The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are launching a joint project to harmonise pharmacopoeial standards for active substances and medicinal products. This initiative aims to reduce the burden on manufacturers by aligning pharmacopoeial standards across different regulatory regions.

The Analysis and Control Laboratories Department of the Turkish Medicines and Medical Devices Agency has become a full member of the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

On 5 September 2024 the EMA and the Heads of Medicine Agencies HMA, published guiding principles that set how EU medicine regulators can use large language models (LLMs), a form of generative AI, focusing on text generation in regulatory science and for regulatory activities. The 10-page document provides high-level recommendations to facilitate LLMs' safe, responsible, and effective use, being of interest to anyone who uses or would like to use such AI models in the future.

The WHO has published a new draft guideline on considerations for the prevention and control of nitrosamine contamination in pharmaceutical products. This guideline applies to all manufacturers of excipients, active pharmaceutical ingredients and finished pharmaceutical products.

On 17 April 2020, the European Parliament voted by 693 to one votes and with two abstentions to delay the entry into force of the EU Medical Device Regulation (MDR) by one year - to 26 May 2021. 

The IPEC (International Pharmaceutical Excipients Council Federation) has published a summarizing position paper on „The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products. The 7-page paper describes the IPEC Federation’s position on the role of excipients when conducting N-nitrosamine risk assessments for medicinal products.

In the context of the revised Annex 1 (we reported), the Contamination Control Strategy (CCS) is currently an issue everyone is talking about. This concept must be implemented by 25 August 2023 – when Annex 1 comes into force.

The Norwegian DNV GL Presafe AS (Notified Body 2460) is now a Notified Body for EU Medical Devices Regulation (MDR) 2017/745.

The new European medical device regulation came into force on 26 May 2021. Parallel, a complete revision of the Medical Devices Regulation MepV was carried out in Switzerland, under the responsibility of the Swiss BAG (Federal Office of Public Health). In context of the alignment of the MepV and the KlinV-Mep with the new EU regulations MDR and IVDR on medical devices, it was also necessary to update the existing MRA (Mutual Recognition Agreement) between Switzerland and the EU. This agreement ensures barrier-free market access and joint implementation. The MRA is, in turn, part of an "overall package" of an institutional framework agreement (Insta), which has not yet been conclusively agreed on. On the contrary: Switzerland has meanwhile broken off negotiations with the EU and described them as "having failed".

The EMA has published the three-year rolling work plan for the Quality Innovation Group (QIG) for the period 2025-2027. QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines.

The EMA has published 3 new or updated questions and answers on Annex 1 of the EU GMP Guide. They deal with bioburden levels and sampling, and open versus closed isolators. The answers are summarised below:

A second revised version of the Q&A document was published on May 26, 2020. A new block of questions (sub-point 6) with six questions and answers deals with the additional temporary flexibility in the GMP/GDP area.

At the end of December 2023, the Indian Ministry of Health revised the provisions of Schedule M of the Drugs and Cosmetics Act. Schedule M describes good manufacturing practices (GMP) for pharmaceutical products.

The European Commission updated the Q&A document on the new transitional provisions for certain medical devices and in vitro medical devices with five additional questions on 18 July 2023.

The Medical Device Coordination Group (MDCG), in collaboration with the Artificial Intelligence Board (AIB), has released MDCG 2025-6, a joint guidance document detailing how the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the new Artificial Intelligence Act (AIA) must be applied in tandem to Medical Device Artificial Intelligence (MDAI) systems.

On 1 June 2020, the PIC/S adopted the following two documents:

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue. 

On August 19, 2020, the US FDA issued a 12-page guideline for the pharmaceutical industry in the form of a Q&A, which deals specifically with questions regarding:

Health Canada and Swissmedic agreed to expand the existing approach to include both the recognition of GMP extra-jurisdictional inspection outcomes (inspections outside Switzerland and Canada) as well as active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope.

The Northern Ireland question was one of the trickiest open issues in the Brexit negotiations. A general political agreement has now been reached with the so-called "Windsor Framework": The European Commission and the government of the United Kingdom have put together a comprehensive package of solutions to reconcile the movement of goods to Northern Ireland while ensuring effective protective measures for the EU's internal market. The Windsor Framework is to replace the previous Northern Ireland Protocol in the future. The legally binding adoption is pending.

The updated 〈1231〉 Water for Pharmaceutical Purposes addresses stakeholder input by clarifying and expanding guidance on water system design, control, and testing.

The MHRA announces its return  to on-site risk based GxP inspections starting from 29 March 2021. However, it is planned to use a combined approach of both, remote and on-site inspections.

The European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have jointly published a comprehensive report on nitrosamine impurities in human medicines, summarising key regulatory and scientific developments since their discovery in 2018.

The French company GMED, based in Paris was designated 15th Notified Body under the new Medical Devices Regulation (MDR) on July 8, 2020.

To ensure market surveillance of medical devices, manufacturers, authorized representatives and importers based in Switzerland must register with Swissmedic within three months of first placing a product on the market. This was revealed in a Swissmedic announcement in late November.
After the applicants have undergone the process, they will be assigned an individual Swiss identification number, the Swiss Single Registration Number (CHRN).

The Chinese NMPA applied for PIC/S pre-accession on 24 September 2021. Although this stage is a voluntary assessment process, gaps are identified between PIC/S membership requirements and the system used by the regulatory agency that is interested.

On 25 June 2020, the Management Board of the European Medicines Agency (EMA) selected the Irish pharmacist Emer Cooke as the new EMA Executive Director from a list of candidates prepared by the European Commission.

On 18 May 2021, Swissmedic and the Federal Office of Consumer Protection and Food Safety (BVL) signed a first Memorandum of Understanding on cooperation in the area of veterinary medicinal products.

On 16 December 2021, EMA published the ICH Q9 draft document on Quality Risk Management (QRM) in step 2b. The draft provides important additional guidance on four specific areas:

• the levels of subjectivity in risk assessments and in QRM outputs,
• the product availability risks,
• the lack of understanding as to what constitutes formality in QRM work, and
• the lack of clarity on risk-based decision-making.

The two facilities of the Italian company Steril Milano S.r.L. in Monza and Reggiolo have closed their doors since March 2021. The company, which offers a sterilization service for medical devices, is facing serious allegations of manipulation. In the meantime, Steril Milano S.r.L's certificate has been withdrawn by the responsible accreditation body.

As of 31 January 2023, using the new Clinical Trials Information System (CTIS) will become mandatory. CTIS serves as a single entry point of contact for the submission and assessment of clinical trial data in all EU and EEA countries. This facilitates the daily business of sponsors in the EU immensely. In the past sponsors had to submit clinical trial applications separately to competent national authorities (NCAs) and ethics committees in each European country to gain regulatory approval. Publication of the trial information is built into the system, as well.

On 1 July 2020, the Swiss Federal Council adopted the revised Ordinance on Medical Devices (MedDO) and the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD).   

The US FDA is planning a gradual re-start of on-site surveillance inspections in cooperation with the Centers for Disease Control and Prevention (CDC).

The European Medicines Agency (EMA) issued a revised Version 7 of its Q&A guidance on nitrosamines dated January 22, 2022. The revision includes a new nitrosamine for testing and an updated section on testing and control of multiple impurities in one product. For such a case, a step-by-step decision tree is presented in Annex 1.

While the European Pharmacopoeia (Ph. Eur.) already includes parts of the ICH Q3D guideline on elemental impurities in the general chapter on Elemental impurities (5.20), the requirements for extractable elements from plastic containers for pharmaceutical use and closures are legally binding.

On 7 August 2025, the World Health Organization (WHO) officially designated Health Canada, Japan's MHLW/PMDA (Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency), and the United Kingdom's MHRA (Medicines and Healthcare Products Regulatory Agency) as WHO-listed authorities (WLAs).

The International Council for Harmonisation (ICH) held its Assembly Meeting in Montréal, Canada on November 5-6, 2024.

After the US FDA already announced the gradual resumption of on-site surveillance inspections in May (we reported), the MHRA is now also following this course. The short Guidance for industry on MHRA's expectations for return to UK on-site inspections published on 11 August 2020 sets out the procedure.   

The European Commission announces that the EUDAMED Actor Registration Module will go live on 1 December 2020. Meanwhile a website has been set up to explain all the necessary steps to register  for access to EUDAMED and the following modules.

Once a year, operation PANGEA takes place, a globally organized action by Interpol against the online distribution of illegally imported medicines. Within this week of action, participating countries check (and close) suspicious websites and seize counterfeit medicines. In addition, this action aims to create public awareness of the issue.

On 4 March 2021, Swissmedic announced the numbers on medicinal products illegally imported into Switzerland. In 2020, 6733 illegal imports were recorded. Compared to the previous year, the number has decreased only slightly.  Among the countries of origin, Singapore has replaced India, which has long been in the lead. It was followed by Western European countries such as the UK and Germany in particular.

Singapore is increasingly being used as a hub by suppliers of illegal medicinal products.

The British MHRA has set up a standalone MHRA-GMDP database> as a new service (alpha release). This step obviously separates the UK from the EudraGMDP where the competent EU authorities publish manufacturing and wholesale approvals, GMP certificates and non-compliance reports.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation until 15 August 2024.

On 16 March 2023, the FDA issued its final guidance on detailed definitions around "suspect products" and "illegitimate products".

In December 2020, the Medical Device Coordination Group (MDCG) of the European Commission published a six-page Q&A document on Notified Body audits of medical device manufacturers during the COVID 19 pandemic. 

POWTECH TECHNOPHARM will once again take place in Nuremberg from 23 – 25 September 2025. In line with the new focus on the GxP-compliant production of pharmaceuticals, GMP-Verlag will also be there this year.

How can manufacturers of pharmaceuticals and APIs detect and prevent nitrosamine impurities in pharmaceutical products and what are possible causes of the contaminations? These questions have been occupying regulatory authorities and of course the pharmaceutical industry for the last two years. Answers are now provided by the 24-page guidance on Control of Nitrosamine Impurities in Human Drugs, which was published by the US FDA on 1 September 2020.

As of 2 December 2021, the new general chapter <1469> on nitrosamine impurities has been added to the United States Pharmacopeia (USP). With this, it is intended to support both pharmaceutical manufacturers and authorities in assessing the presence of nitrosamines and implementing appropriate control strategies and analytical procedures. The chapter is aligned with the current FDA guidances.

According to Swissmedic, the independent SwissGMDP database will be launched in the first quarter of 2024. The database will be maintained similar to the European EudraGMDP database of the EMA. The GMP or GDP certificates of every company in Switzerland that has a valid Swissmedic operating licence will be listed. Contrary to the EudraGMDP, the SwissGMDP certificates contain all approved activities, i.e. the GDP activities and Switzerland-specific GMP activities of the Swiss companies will also be listed in the certificates.

On 24 February 2021, the U.S. Food and Drug Administration announced a revision to its September 3, 2020, Guidance for Industry, Control of Nitrosamine Impurities in Human Drugs. The revision extends the recommended timeframe for manufacturers to assess the risk of nitrosamines in active pharmaceutical ingredients (APIs) and drug products from 6 to 7 months.

The European Commission has published a Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).

The HPMC (Committee on Herbal Medicinal Products, HPMC) of the EMA has published a concept paper on Good agricultural and collection practice for starting materials of herbal origin on 1 March 2022. Of interest to GMP professionales is, that the revision of the original guideline dating back to 2006, will address open questions about the applicability of GACP versus GMP, or a requirement of a combination of both. With a growing market for herbal medicinal product, e.g., Cannabis products, enhanced guidelines on the subject intent to clarify open issues.

On 9 January 2024, the Swiss Medicines Agency Swissmedic informed about critical deficits in the system of medical device regulation. 

The International Council for Harmonisation (ICH) held its Assembly on 4-5 June 2024 in Fukuoka, Japan, alongside meetings of 13 Working Groups, the ICH Management Committee, and the MedDRA Management Committee. ICH welcomed new members ANMAT (Argentina) and JFDA (Jordan), expanding to 23 Members and 35 Observers.

EMA has published a Q&A on how to reflect third party audit(s) in part C of the QP declaration.

This week the WHO published a draft guideline on GMP for excipients used in pharmaceutical products. With the original guideline published in 1999, a revision was overdue. Excipients play an essential role in pharmaceutical dosage forms and their impact on the quality of the finished product is considerable. The guideline is addressed to excipient manufacturers and pharmaceutical manufacturers.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for wholesalers and manufacturers in response to the Windsor Framework, which updated the terms of Brexit.

The FDA has published Considerations for Complying with 21 CFR 211.110 for comment.

On 15 May 2020, the European Commission has announced to extend the time frame for the consultation on Annex 21 Importation of Medicinal Products until 20 August 2020. This step is justified by the challenges arising in connection with COVID-19.

The Medical Device Coordination Group (MDCG) has updated its questions and answers document on requirements relating to notified bodies to explain how notified bodies can use previous assessments to avoid unnecessary duplication of work.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is planning to establish a new AI-based "regulatory sandbox" to help artificial intelligence (AI) developers test and provide evidence for their technologies in a virtual space under regulatory monitoring. The so-called AI-Airlock is expected to go into operation in April 2024.

What should a crisis-proof drug supply in Europe resemble? In this regard, the European Commission presented a 25-page pharmaceutical strategy on November 25, 2020. It was awaited with great interest. One thing is for certain: the implementation of the strategy will not leave the EU pharmaceutical legislation unaffected.

The mutual recognition of inspections of certain veterinary medicines between the European Union and the United States has reached a significant milestone: On 31 May 2023, the US FDA recognised the capability of 16 EU Member States to carry out GMP inspections for certain veterinary products at a level equal to the US. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines.

The Medical Device Coordination Group MDCG, a group of Member States experts, endorsed a joint implementation plan on the implementation of the IVDR, more precisely Regulation (EU) 2017/746 on invitro diagnostic medical devices. The plan should serve to set priority actions and monitor their implementation.  The IVDR will enter into force on 26 May 2022 with an extended transitional period of five years.

Team-NB, the European association of Notified Bodies, strongly recommends that medical device manufacturers of Class D devices submit applications for In Vitro Diagnostic Regulation (IVDR) certification this year to ensure timely processing.

FDA’s CDER has updated the recommended acceptable intake (AI) limits for certain hypothetical nitrosamine drug substance-related impurities (NDSRIs) and other identified nitrosamine impurities (Table 1) as well as the recommended interim AI limits for certain nitrosamine impurities for approved or currently marketed products (Table 3).

The European Medicines Agency (EMA) has answered nine questions on the application of revised Brexit rules to centrally authorised medicinal products for human use in Northern Ireland (Regulation (EU) 2023/1182).

In collaboration with the World Health Organization (WHO), the European Medicines Agency (EMA) supports a pilot programme that allows pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities.

Already in March last year, an adaption of the Delegated Regulation (EU) 2016/161 on safety features allowed a temporary derogation of the obligation for wholesalers to deactivate the individual identifier (IE) of medicinal products exported to the UK - as a third country we reported). This exemption was granted for the year 2021.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has elaborated a document describing the principles for the declassification of documents pertaining to the CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) procedure while ensuring when necessary, the confidentiality of information.

How is Switzerland adapting to the EU regarding the implementation of MDR, IVDR and ICH Q12?
 

On 18 September 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its recommendation to suspend all ranitidine-containing medicinal products in the EU due to the presence of low levels of the impurity N-nitrosodimethylamine (NDMA).This follows a re-examination of CHMP’s April 2020 opinion, which was requested by one of the companies marketing ranitidine medicines. The EMA has published a detailed statement on this recommendation.

PIC/S has published the following two guidance documents for GDP inspectors: an "Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain" (PI 044-1) and a "Questions & Answers (Q&A) document regarding the PIC/S GDP Guide" (PS/INF 22/2017).

On 1 August 2023, the UK government published a statement on the indefinite extension of CE marking recognition beyond 2024. MHRA clarifies: This extension does not apply to medical devices and in vitro diagnostic medical devices.

The World Health Organization (WHO) has released a draft document titled Points to Consider in Continuous Manufacturing of Pharmaceutical Products for public comment.

The European Commission, the EMA and the European Medicines Regulatory Network have developed a 7-page Q&A to guide pharmaceutical companies in making flexible adjustments to the regulatory framework during the COVID 19 pandemic. The EMA has established a task force for this purpose, to take quick and coordinated regulatory action.

The US Food and Drug Administration (FDA) released a draft guidance detailing how manufacturers should report postapproval manufacturing changes for licensed biosimilar and interchangeable products.

The EMA has published a pilot report on the creation and testing of electronic product information (ePI) in regulatory procedures. The findings suggest that the EU regulatory system is ready for ePI and can begin phased implementation, though further development is needed, including additional features and IT system integration.

This guideline is an essential reading for all regulatory professionals involved in preparing MAAs. It describes the revised requirements for assessing the potential environmental risks of human medicinal products. The guideline was adopted on 15 February 2024 and will enter into force on 1 September 2024. The changes and extended requirements for environmental risk assessment will be mandatory for all pharmaceutical companies placing their medicines on the EU market.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published further guidance for the preparation of dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance.

The European Medicines Agency (EMA) announced that the deadline for the submission of risk assessments for all human medicines presenting a risk for the presence of nitrosamine impurities or (cross)contaminations will be extended to 1 October 2020. The announcement was made just one day ahead of the original deadline scheduled for 26 March 2020. This will give all companies affected more time to review their manufacturing processes and carry out the required risk assessments.

The reason given for this step is the challenges and impact of the restrictions in place to combat the COVID 19 pandemic.

ISPE has released the new GAMP^® Guide: Artificial Intelligence, addressing the use of AI in GxP-regulated areas within the life sciences sector.

ICH Q3D (R2) has reached Step 4 of the ICH-Process and will now be distributed to the Member States for implementation. The revision (R2) focused on the establishment of limits for elemental impurities by the dermal route of exposure, summarized in a new Appendix 5 and error corrections of the PDEs for Silver (oral), Gold (oral, parenteral and inhalation) and Nickel (inhalation).

At its June 2025 session, the European Pharmacopoeia Commission (EPC) adopted three revised texts on pharmaceutical waters. This is an important step towards achieving international harmonisation with the pharmacopoeias of India, Japan and the US.

EMA has updated its Q&A document on drug-device combination products by end of June 2021. It includes the current requirements under the Medical Devices Regulation (MDR), which entered into force on 26 May 2021. Marketing authorisation holders of combination products are provided with detailed information on all current adjustments.

On 10 October 2022, the EMA published a 24-pages document on data quality (DQ) framework, which is open for consultation until 18 November 2022. As the topic of data quality and data overall becomes more and more critical to regulating medicinal products, a Data Quality Framework for EU medicines regulation is a logical consequence to provide a unitary approach. Thus, the amount of data that digitalisation brings along not only opens up new possibilities, but also increasingly complex data landscapes.

EMA’s Biologics Working Party has updated the question-and-answer document for biological medicinal products, adding information on nitrogen gas for backfilling, container closure systems and prior knowledge.

According to a press release from the UK government Switzerland and the United Kingdom have started negotiations on a modern and free trade arrangement (FTA) this month.

On September 15, the U. S. Pharmacopeia USP published the final draft of the chapter <1083> Supplier Qualification.

In June 2022, the European Commission published the Question & Answers document on safety features for medicinal products for human use in version 20, coming along with one new Q&A on UI verification of authenticity.

On 16 April 2021, Swissmedic announced that it is seeking harmonization with EU regulations regarding the handling of nitrosamine impurities.

On February 6^th, 2023, the European Medicines Agency (EMA) published the first revision of the guideline "ICH Guideline Q9 (R1) on Quality Risk Management (QRM) Step 5".

The 27-page document includes "principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.“

The US FDA announced that it is postponing most foreign inspections through April with immediate effect due to the Coronavirus disease. Inspections outside the US that are considered critical will be reviewed by the FDA on a case-by-case basis.

The BIO INN Laboratories of the Egyptian Drug Authority (EDA) have joined the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), as an associated member.

The European Commission (EC) Medical Device Coordination Group (MDCG) has published guidance on qualification of in vitro diagnostic medical devices (IVDs) (MDCG 2024-11). The guidance determines which products fall under the scope of Regulation (EU) 2017/746 (IVDR) as IVD.

The EMA has published a four-page consultation document in the form of Q&As concerning the physical attendance and the place of a personal residence of a Qualified Person on 11 May 2022. The guidance states that the work of a QP must be adapted to current standards to enable remote certifications without a QP being present at the site. A public consultation is possible until 13 June 2022.

EMA and the Korean Ministry of Food and Drug Safety (MFDS) have signed an agreement to exchange confidential information on medicines for the treatment, diagnosis or prevention of COVID-19.

The FDA issued a draft guidance outlining a framework of methods, designs and controls for preventing cross-contamination of non-penicillin beta-lactam antibacterial drugs and compounds, which serves as an update for a 2013 guidance with the same title. (Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability).

The Active Pharmaceutical Ingredients Committee (APIC) has published the 2^nd revision of its nitrosamine risk management guidance for API manufacturers. This guidance document was first prepared in 2020 by the APIC Nitrosamines Task Force.

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

On 9 August 2023, Swissmedic announced its accreditation for GMP/GDP inspections in the field of ATMPs (Advanced Therapy Medicinal Products). Previously, the authority's competence confirmation was limited to medicinal products.

On 27 October 2020, the European Medicines Agency (EMA) published an implementation plan to reduce nitrosamine impurities in medicinal products.

The Swiss Federal Council intends to grant an extended period for the certification of medical devices in accordance with the extension of the corresponding EU regulation (we reported). This will require an amendment of the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The revision of the two ordinances is planned for autumn 2023.

The European Pharmacopoeia (Ph. Eur.) has published a significantly revised version of general chapter 3.2.1 Glass containers for pharmaceutical use in Pharmeuropa 37.3, marking the first major update since 2019 (Ph. Eur. Supplement 9.6).

The WHO has published three GMP-relevant draft documents in recent weeks:

• WHO good manufacturing practices for investigational products
• WHO good manufacturing practices for medicinal gases, Rev.1
• WHO good practices for research and development facilities of pharmaceutical products

The Swedish company Intertek announced on 15 May 2020 that Intertek Medical Notified Body AB (IMNB) has been designated as the 14th Notified Body against the EU Medical Device Regulation 2017/745 (MDR). 

On 17 February 2021, Swissmedic announced that it will now permanently support the "Orbis" project. Orbis enables manufacturers to submit their marketing authorization applications submitted to the US FDA simultaneously to other international regulatory authorities, provided they participate in the project.

On 27 March 2024, Japan's PMDA (Pharmaceuticals and Medical Devices Agency) published an English-language version of its updated recommendations on the quality, safety, and efficacy of biosimilars. The 14-page document, Questions and Answers on Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars, has been updated to reflect the current state of scientific knowledge. The revised sections of the document are indicated and relate to Q&As 9, 10, and 11.

EMA has updated ist questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products.

Following the detection of 1-nitroso-4-methyl-piperazine (MeNP) impurities in some batches of rifampicin in February 2021, the EMA is requesting manufacturers to test the drug for the presence of MeNP. 

The US FDA, in cooperation with the Indian authorities, has seized 500 shipments of illegal and potentially dangerous unapproved prescription drugs and medical devices. The products were in transit to American consumers by international mail.

On 30 April 2020, the European Commission has announced to extend the time frame for the second consultation on Annex 1 Manufacture of Sterile Products until 20 July 2020. This step is justified by the challenges arising in connection with COVID-19.

On 7 November 2023, MedTech Europe published a position paper on the Medical Devices Regulation (MDR (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746). In the report, the association presents its vision for a regulated legal framework and outlines possible solutions to the ongoing challenges, which have not been overcome after the implementation phase of the MDR and IVDR.

On 15 July 2021 the PIC/S recommendation document How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management (PI 054-1) came into force. The document provides practical guidance and covers all relevant steps in change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks.

On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 "Computerised Systems". The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA.

Shortly after the publication of the EMA's final assessment report on nitrosamine impurities in medicinal products (we reported), a 15-page Q&A for marketing authorisation holders and applicants was published on 6 August 2020.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has published a final assessment report on nitrosamine impurities.

In its Q&A section on GMP and GDP, EMA has added questions and answers on additional guidance to Annex 8 on sampling excipients at risk of glycol contamination, emphasising stringent measures for high-risk substances. In seven key questions, EMA highlights the risks of diethylene glycol (DEG) and ethylene glycol (EG) contamination, emphasising the responsibilities of manufacturers and supply chain management.

The European Medicines Agency EMA has further updated its Q&A on nitrosamine impurities. The document is intended to support marketing authorization holders of human medicinal products and considers the latest regulatory requirements (we reported).

The International Coalition of Medicines Regulatory Authorities, ICMRA, has published a comprehensive reflection paper on experiences with different inspection models to maintain GCP and GMP inspections during the covid pandemic. The working group responsible for the paper was composed of representatives from various regulatory agencies around the world. To anticipate the group's conclusion: Remote inspections enable minimal regulatory oversight during the pandemic but will not be able to replace on-site inspections in the future.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of the EMA has published a Q&A for the practical handling of processes for mutual recognition of authorisations during the COVID 19 crisis. 

The International Council for Harmonisation (ICH) has made the Minutes of the ICH Assembly Meeting in Singapore, in November 2019, publicly available. In contrast to the already published press release we reported), the meeting minutes include new details on the following interesting projects for the GMP area:

On 6 December 2021, the EMA published all stakeholder comments received on the Guideline on quality documentation for medicinal products when used with a medical device (we reported). It will enter into force on 1 January 2022. Comments were received from 36 different stakeholders from all over Europe, including e.g., MedTech Europe, Medicines for Europe or the Parenteral Drug Association, PDA.

On 23 October, the European Parliament has adopted a resolution to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to address ongoing implementation challenges and support patient access to essential medical devices by 2025.

The new "swissdamed" medical devices platform has been gradually rolled out since 6 August 2024. The first release of the "Actors" module enables economic operators to register online.

MedTech Europe is calling on EU lawmakers to align cross-sector digital legislation – the AI Act, Cybersecurity Act, Data Act and the European Health Data Space (EHDS) – with medical-device requirements to avoid duplicative or conflicting obligations.

In December 2019, the European Medicines Agency (EMA) revised a four-page Q&A document on the EU-US Mutual Recognition Agreement (MRA) on marketing authorisation applications and variations.

With the publication of Delegated Regulation 2022/2239, the European Commission has released the revised and amended labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation (CTR). This eliminates the need to retroactively label the expiration date on the primary packaging of unapproved investigational products for which new stability and shelf-life data become available over time.

The Japanese MHLW (Japanese Minister of Health, Labour and Welfare) has released the 18^th Edition of the Japanese Pharmacopoeia (JP) as an English translation for download free of charge.

The Swiss Agency for Therapeutic Products, Swissmedic, will, according to an announcement made on 1 September 2020, carry out regular GMP and GDP inspections on site again with immediate effect. Protective measures such as distance and hygiene rules must continue to be followed and infections must be traced.

The Australian Therapeutic Goods Administration, TGA,  updated its GMP approach to overseas manufacturers of medicines and biologicals on 1 November 2021. With the COVID-pandemic still being an issue, TGA named remote inspections the only currently available option for certification applications.

The PIC/S Committee has granted the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) the status of Associated Partner Organisation.

The European Commission published version 18B of the Q&A on safety features for medicinal products in late May 2021. In the 34-page document, question 1.14 "Are there mandatory specifications for tamper evidence?" was updated.

On 26 July 2022, the EMA published a concept paper to start the process for the revision of the Guideline on the chemistry of active substances. The document dates from 2016 and does not consider the nitrosamine issue that has developed in recent years.

On 16 February 2023, the European Parliament voted positively to extend the deadline for the certification of medical devices under the EU Medical Devices Regulation (MDR). In January, the deadline extension was proposed by the European Commission to prevent massive supply shortages. Not enough Notified Bodies are available for the recertification of many medical devices, as a requirement of the MDR.

On 8 November 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a blog post announcing the resumption of international on-site inspections.
Important to know: Notwithstanding, the ‘expiry’ of GMP certificates issued by the MHRA will again be extended until the end of 2023.

Last month, the EMA published the final guideline on computerised systems and data integrity in clinical trials, which will enter into force on 10 September 2023. Clinical trials are increasingly using computerised systems for data collection, which come with progressively more complex user surfaces.

On its Inspectorate Blog, the UK MHRA (Medicines and Healthcare products Regulatory Agency) has critically reviewed the implementation of the requirements on HBELs and the prevention of cross contamination in shared facilities. What are the expectations to be met and what deficiencies have been identified in recent inspections?

Swissmedic has established the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

On 21 September 2021, an amendment to Delegated Regulation (EU) 2016/161 was published in the Official Journal of the European Union. Article 47 "Evaluation of notifications" was adapted and in Annex I, containing the list of medicinal products exempted from the obligation to bear the safety features, a new entry has been added.

On 8 March 2023, the European Commission published Delegated Regulations (EU) 2023/502 and 2023/503 to extend the reassessment period for notified bodies under MDR/IVDR to five years. The new time frame has already come into force.

The EMA has published a new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations (MDR and IVDR) for combinations of medicinal products and medical devices.

The European Medicines Agency has published two new concept papers for Annex 4 and Annex 5 for veterinary medicinal products on 11 November 2021...

The WHO has released a series of new and updated guidelines related to pharmaceutical manufacturing, testing, and development, published as part of Technical Report Series No. 1060 (TRS 1060). Annexes 2 through 9 address a range of topics, including nitrosamine control, GMP for excipients, bioanalytical methods and blood establishments.

As part of the recent publication of EMA's Annual Report 2022, the 3-year work plan 2021-2023 has also been updated. The 13-page work plan has been developed with a main focus on the network strategy and the scientific regulatory strategy (RSS). The security and resilience of the supply chain is of particular importance.

The PMDA has established an office in Washington, D.C. This is the PMDA's second overseas office, following the establishment of the Asia office in Thailand in July.

On 31 October 2023, Swissmedic published a Q&A with the title "Interpretation of GMP Annex 1 2022 (Rev. 1)". In the 25-page document, the Swiss Agency for Therapeutic Products provides key answers to questions related to Annex 1, which came into force in August 2023, and to repeatedly asked questions from the previous version.

On 3rd June 2020, the European Commission published a concept for the safe and affordable supply of medicinal products in Europe. 
The initiative "Pharmaceutical Strategy - Timely patient access to affordable medicines" is designed to facilitate innovation in the pharmaceutical industry. 

On 11 January 2021, the European Commission (EC) announced what needs to be considered when Notified Bodies conduct remote audits of medical device and in vitro diagnostic manufacturers due to the COVID-19 situation.

Swissmedic has published an updated version of its technical interpretation for a Product Quality Review (I-SMI.TI.14e).

On 18 April, the EMA launched a new draft version of the Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin. This update brings the document up to date with current standards, incorporates the increased development of indoor growing technologies and also covers best practice and legal interpretations published over the last 10 years.

The 3-year work plan for the EU GMDP Inspectors Working Group (IWG) aligns with Network Strategy and Regulatory Science Strategy (RSS) goals, emphasising supply chain integrity, product quality, and the impact of new manufacturing technologies. 10 documents of the GMP Guide will be revised or newly launched.

The WHO published a draft on GMP for investigational products in November 2020. The 28-page working document comprises 18 chapters and can be commented on until 6 January 2021. The guideline currently in force and consisting of 12 pages was published in 1996.  

EMA has added three new questions to its guidance on good manufacturing practices to address risks of diethylene and ethylene glycol (DEG/EG) contamination in glycerol and other excipients.

The Medical Device Coordination Group (MDCG) has revised its guidance regarding the designation, re-assessment, and notification of conformity assessment bodies and notified bodies.

On 25 October 2022, the UK Regulatory Agency MHRA, announced that the introduction of the future UK Medical Device Regulation will be delayed by twelve months. The intended date for introduction of the new and standalone regulation is now set for July 2024.

Swissmedic published an updated version of Technical Interpretation 17: Responsible Person: requirements on 26 August 2024. The document outlines the Swiss Inspectorate’s understanding of an RP in accordance with the Medicinal Products Licensing Ordinance (MPLO). It can also serve as a reference for companies to assess whether an individual meets the criteria for applying to Swissmedic to act as an RP.

On 14/15 March 2022, the ISPE Aseptic Conference took place in North Bethesda, USA. The hybrid conference opened with a keynote presentations on regulatory news.

Paul A. Gustafson, who is chairing the PIC/S this year, gave an overview on the PIC/S activities and in this context referred to the future Annex 1 of the EU GMP Guide: The document is in its final adoption process. A publication is to be expected between the beginning of July and the end of September this year. The European Commission is currently awaiting the review of the PIC/S and the WHO. Both organisations had contributed to the two draft documents of Annex 1. The European Commission has not revealed a release date, yet.

The Medical Device Coordination Group (MDCG) has updated its manual on the classification of products that are on the borderlines between medtech and other regulatory categories (Version 4).

Swissmedic has issued an update regarding non-standardized medicinal products, revising an information sheet and the list of products impacted by a specific manufacturing regulation. This product category addresses patient-specific preparations.

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

On 11 October 2022, the ICH published the revised Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin as Step 2 document. This guideline addresses the testing and evaluation of the viral safety of biotechnology products and explains what data should be provided in the application dossier for the marketing and registration of these products.

From 6 to 7 November 2023, the PIC/S Committee Meeting took place in Bangkok, Thailand, chaired by Paul Gustafson from Health Canada. The Ministry of Public Health of the Thai Food and Drug Administration (Thai FDA) hosted the meeting.

The meeting was attended by 37 of the 56 Participating Authorities (PAs) as well as various applicants, pre-applicants and partner organisations.

The European Medicines Agency (EMA) has added 7 Q&As to their quality of medicines questions and answers. They refer to EMA‘s 1998 guidance on the shelf-life of sterile products for human use after opening or reconstitution (CPMP/QWP/159/96 corr).

As announced by the UN Commission on 2 December 2020, cannabis was removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs following WHO's recommendation.

On 12 January 2023, the FDA signed a Mutual Recognition Agreement between the United States and Switzerland, allowing the FDA and Swissmedic to share each other's GMP inspectional findings, which will reduce unnecessary costs and duplicative efforts.

Starting 1 October 2025, the European Medicines Agency (EMA) has begun accepting FDA inspection findings for manufacturing sites located outside the United States. The decision follows a successful pilot under the EU–US Mutual Recognition Agreement (MRA).

The revised ISO 14644-5:2025 “Cleanrooms and Associated Controlled Environments – Part 5: Operations” replaces the previous 2005 edition. It sets out the basic requirements for planning, operating and controlling cleanrooms, as referenced in regulations such as EU GMP Annex 1.