CRED Getting the CMC Dossier Right 2024

29/08/2024

Types of Submission

Full 3.2.S

CEP

⚫ 3 Options:

ASMF

⚫ Full 3.2.S

• Mostly centralised/NCE (but also possible for established DS)

⚫ Active Substance Master File (ASMF)

• NCE / established DS / PhEur monographs

•

Not for biologicals / biosimilars

Letter of access

•

• Version numbers, dates, sequences

• Applicant’s Part, Restricted Part, QOS for each

• ASMF allows to withhold some intellectual property from customers

• Full ASMF submitted to Regulatory Authority

The Organisation for Professionals in Regulatory Affairs

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Types of Submission

Certificate of the European Pharmacopoeia (CEP)/Certificate of suitability (CoS)

PhEur monographs

•

• Confirms suitability of the Ph Eur monograph to control quality of API • or dictates extra tests and limits considered necessary (e.g. related substances, residual solvents, metal residues)

• CEP assessment carried out at EDQM, Strasbourg

• Surrogate for EU Regulatory Authority review • Different types: chemical, TSE, herbal, chemical + TSE, chemical + sterile, chemical + TSE + sterile • Dossier still requires information applicable to the FPM (3.2.S.4, 3.2.S.5 – product specific quality attributes? E.g. physicochemical, microbiological) and information that may not be on the CEP (3.2.S.6, 3.2.S.7) • Located in Mod 3.2.R and as Annex 5.10 of Application Form • Validity? • https://extranet.edqm.eu/publications/recherches_CEP.shtml • Completeness? • Annexes • Issued customer specific => DoA

• Applicant's duty to provide GMP information to cover CEP holder's sites

The Organisation for Professionals in Regulatory Affairs

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