EMA/CMDh: Update of the Q&A Document on Nitrosamines

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In December 2022, the Q&A document entitled "Questions and answers for marketing authorisation 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", which was jointly prepared by the EMA and the CMDh, was updated twice and has now been published on the EMA website in its new version 14.

Version 13

The additions and changes made at the beginning of December, which were included in version 13 of the document, mainly refer to question 10 "Which limits apply for nitrosamines in medicinal products?". In this question, for example, further nitrosamine compounds and their sources were added to Table 1 and additional information was added to the agenda texts.

Version 14

Finally, version 14 of the Q&A document was published in the middle of December. Questions 20 "What are the regulatory steps taken by authorities following the identification of an N-nitrosamine exceeding the AI?" and 21 "What is the approach to control the presence of nitrosamines until a substance specific AI is established?" have been updated, and question 22 "What is the approach to control the presence of N-nitrosamines exceeding the AI during CAPA implementation?" has been added.

The new version of the Q&A document "Questions and answers for marketing authorisation 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" and further information can be found on the EMA website in the section "Nitrosamine impurities".