EMA/CMDh updated Q&A document on nitrosamines

Revision 22 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” has been published on the EMA website.

The additions and changes made mainly concern the questions 10 and 22.

Updates to Q&A 10 to clarify the applicable acceptable intake (AI) limit to different administration routes and accepted in vivo study type.

Update of Q&A 22 to highlight expectations for the submission of changes in shelf-life and storage conditions required to comply with the interim limit during CAPA implementation.

SOURCES:

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities/nitrosamine-impurities-guidance-marketing-authorisation-holders