Issue 25: Pharmaceutical regulatory roundup

BY DR TIM SANDLE  | 1 October 2024

Catch up with the latest news from around the pharmaceutical industry with issue 25 of our regulatory review, curated by Dr Tim Sandle.

Nitrosamines

The European Medicines Agency (EMA) has published the sixth revision of Appendix 1 (“Acceptable intakes (AIs) established for N-nitrosamines”) of the EMA 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 (EMA/409815/2020 Rev.21).