Spring Intro 2023

03/03/2023

Common Deficiencies – 3.2.P.5 (ctd.) • Control of drug product (Specifications/Justification, Analytical Procedures/Validation, Batch Analyses) ~ 80 % • Justification of specifications • Investigation for presence of N-nitrosamines in human medicinal products is mandatory • Nitrosamines • Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. • Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities. • the risk evaluation not submitted • Risk “negligible” X • Risk or no risk

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Common Deficiencies – 3.2.S.3

• Nitrosamines

• Failure to follow the EMA guidance

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral procedures/nitrosamine-impurities#guidance-for-marketing-authorisation-holders section

There is a very low risk that nitrosamine impurities at the levels found in medicines could cause cancer in humans.

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