CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.R Regional guidance

Any additional drug substance information specific to each region is provided here

For EU*:

• Certificates of Suitability (CEP)

• Statement of Compliance to Annex 1 of Directive

2001/83/EC Part 1, module 2, paragraph 3.2(9) i.e. specific measures concerning the prevention of transmission of TSE

* Qualified person declarations for GMP of active substances are located in annex 5.22 to Module 1

The Organisation for Professionals in Regulatory Affairs

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Feasible ways to submit DS data

Guideline on Summary of Requirements for Active substances in the Quality part of the Dossier (CHMP/QWP/297/97) – depending on the classification i.e.

New active substances

•

• Existing active substances not described in Ph. Eur. or member state pharmacopoeia, or • Existing active substances described in Ph. Eur. or member state pharmacopoeia, and the nature of drug, i.e. organic, inorganic, herbal, the required data may be submitted in one of three ways

The Organisation for Professionals in Regulatory Affairs

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