News about GMP/cGMP

05.08.2022

CHMP: Extended Deadline for Nitrosamine Step 3 Revision and Q&A update

CHMP: Extended Deadline for Nitrosamine Step 3 Revision and Q&A update

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 extension is to allow companies to carry out a thorough investigation and identify any necessary risk mitigation measures, in particular regarding nitrosamines that may result from active substances. This extension does not affect the deadline for the completion of the level 2 confirmatory tests for chemical medicinal products. This will continue to end on 26 September 2022, by which time marketing authorisation holders should submit the full results of stage 2.

Certificates of Suitability
A similar approach is taken for Certificates of Suitability (CEP) and therefore the previously announced deadline (notice to all CEP holders for synthetic active substances regarding the presence of nitrosamines) for the submission of all necessary revisions under Step 3 is thus extended to 1 October 2023. Nevertheless, CEP holders are invited to submit their amendments as soon as the investigations are completed and thus before the deadline mentioned above.


Q&A document on nitrosamine impurities
The changes are also reflected in the accompanying Q&A document. Question 3 on the “call for review” has been updated accordingly:

  • For product containing chemically synthesised APIs, confirmatory testing activities at Step 2 are expected to be finalized at the latest by 26th September 2022.
  • The deadline for the submission of any changes required to Marketing Authorisations is by 1 October 2023.
  • For product containing biological APIs, confirmatory testing activities at Step 2 and submission of any changes required to Marketing Authorisations are expected to be finalized at the latest by 1 July 2023.

Source:

EMA: Q&A on nitrosamine impurities in human medicinal products
EMA: Nitrosamine impurities website


 

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