CRED 8 Presentations

01/07/2024

How to address possible nitrosamines impurities

• Risk for nitrosamine formation should be evaluated for all chemical and biological medicinal products • If a risk cannot be excluded, confirmatory testing data should be provided • To come to a positive B/R it should be confirmed that the AI is met throughout shelf life of the proposed product, no possibility for post-approval commitment • Timely action essential considering time needed for performing testing as well as establishment AI and the limited remaining time after restart procedure

The Organisation for Professionals in Regulatory Affairs

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Common objections regarding clinical studies

• Primary endpoints; • Strength used;

• Suitability fasting or fed conditions; • Justification extrapolation of PK data:

- with healthy volunteers to a patient population; - from one age group to another (e.g. from adults to adolescents); - in 1 indication to other indications

The Organisation for Professionals in Regulatory Affairs

40