CRED Getting the CMC Dossier Right 2024

28/08/2024

Feasible ways to submit DS data (cont …)

3 main ways to submit Drug Substance data:

1. Full details of manufacture: originator proprietary data or via cross-referral to another application 2. Active Substance Master File (ASMF): (commonly referred to as a DMF - Drug Master File). ● Applicant files Applicant’s (Open) part ● Manufacturer files both Closed (confidential) and Applicant’s parts.

3. Certificate of Suitability to the monograph of the European Pharmacopoeia (CEP)

● Data assessed by EDQM, CEP is issued and this is filed in dossier ● Replaces many sections of 3.2.S

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ASMF procedure

• Full details of chemistry, manufacturing process, quality control submitted to regulatory authority by holder of the ASMF according to Guideline

• Active Substance Master File Procedure (CPMP/QWP/227/02 or EMEA/CVMP/134/02)

• Applicant’s Part included in Marketing Authorisation (MA) Application

• Letter of Access (original) permitting reference to the ASMF by each applicant required to be filed by ASM and copy included in MA dossier • Emphasis on demonstrating that all potential impurities from synthesis can be controlled

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