28.01.2021
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.
22.01.2021
PIC/S has updated the following four Aide-Mémoires, which became effective on 1 January, 2021:
21.01.2021
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.
19.01.2021
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.
15.01.2021
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.
15.01.2021
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.
14.01.2021
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.
14.01.2021
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.
14.01.2021
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.
21.12.2020
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.
10.12.2020
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.
10.12.2020
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.
04.12.2020
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.
03.12.2020
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.
02.12.2020
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.
27.11.2020
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.
25.11.2020
In November 2020, the WHO published a first draft on GMP for research and development facilities.
20.11.2020
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.
20.11.2020
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).
20.11.2020
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.
13.11.2020
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.
06.11.2020
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.
30.10.2020
On 27 October 2020, the European Medicines Agency (EMA) published an implementation plan to reduce nitrosamine impurities in medicinal products.
23.10.2020
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.
23.10.2020
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.
16.10.2020
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.
02.10.2020
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.
02.10.2020
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.
25.09.2020
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.
25.09.2020
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.
18.09.2020
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.
07.09.2020
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.
04.09.2020
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.
03.09.2020
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.
28.08.2020
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:
28.08.2020
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
- Manufacturing
- Requirements for the supply chain
- Inspections
- Pending applications for approval and
- Changes in manufacturing facilities for already approved medicinal products
during COVID-19.
21.08.2020
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?
According to the MHRA Inspectorate Blog, answers can be found in these two PIC/S documents:
14.08.2020
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.
07.08.2020
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.
07.08.2020
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.
It replaces the document 'Information on nitrosamines for marketing authorisation holders' EMA/428592/2019 published in September 2019, which was withdrawn.
22.07.2020
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.
22.07.2020
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has published a final assessment report on nitrosamine impurities.
17.07.2020
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).
10.07.2020
The French company GMED, based in Paris was designated 15th Notified Body under the new Medical Devices Regulation (MDR) on July 8, 2020.
10.07.2020
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.
03.07.2020
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.
19.06.2020
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).