EDQM: Nitrosamines and CEPs

As recently reported in detail in our News, the Q&A document "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 been updated again and published on the EMA website. On the one hand, the new Q&A document contains new scientific approaches for the categorization of N-nitrosamines as well as for the determination of acceptable intakes (AIs) and the new annexes Appendix 2 and 3.

The EDQM has now published the resulting measures for CEP holders in its Newsroom.

The measures are divided, in very basic terms, into the following groups:

Newly categorized N-nitrosamines

Here, CEP- holders are requested to adjust their risk assessments, control strategies, and CEP applications in light of the new acceptable intakes (AIs) and submit a request for minor changes to the EDQM.

N-nitrosamines applications already submitted

Here, CEP holders are encouraged to proactively update risk assessments and CEP applications to reflect the new information from the Q&A document and submit the new data.

New N-nitrosamines and substances not listed in the annexes of the Q&A document

Here, CEP holders should generally use the so-called "Carcinogenic Potency Categorization Approach (CPCA)" described in the revised Q&A document to determine the acceptable intakes (AIs) and the resulting risk assessment and control strategy.
As usual, should there be any further questions regarding the respective CEP applications, these can be sent to EDQM via email box with reference to the respective dossier.

Please find here the updated Q&A document "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" as well as the information for CEP holders in EDQM's Newsroom.