CRED Getting the CMC Dossier Right 2024

29/08/2024

Assessment

Fixed require ments

⚫ Basis of quality assessment

● Directives, Regulations

● other commission documents

● Ph. Eur./national pharmacopoeias

● ICH & EMA guidelines & supportive Q&As

● EMA reflection papers

Variety of interpre tation

● Good Practice guides and other regulatory documents

● published evidence

● good regulatory assessor thinking

The Organisation for Professionals in Regulatory Affairs

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Module 1 and the drug substance

All applications :

● Application form – Addresses – All sites (incl. intermediate manufacturing sites) – CEP or ASMF number and version ● CEP/letter of access to ASMF – Addresses – CEP currently valid? Declaration of access filled in? complete with all annexes? – ASMF: latest version provided to CA?

Some applications :

● EU-GMP certificates for sterile DS – Inspection less than 3 years ago? ● Similarity assessment (Orphan) – Appropriate amount of information ● New active substance claim

● QP declaration

– Common/from all BR sites – Addresses – Audit less than 3 years ago?

The Organisation for Professionals in Regulatory Affairs

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