CRED Getting the CMC Dossier Right 2024

28/08/2024

Role of Regulatory Team Member [3]

Typical deliverables during registration ● Determine the CTD contents and structure (e.g. enhanced vs traditional, use of ICH Q12, where information will be located, use of post approval comparability protocols) ● CTD authoring: Set timelines, identify authors reviewers and approvers, story board the control strategy, plan review meetings, identify and agree mitigation strategies on risks ● Consider the need for pre-submission agency meetings ● Post submission – Plan for queries

– Plan for pre-approval inspections – Plan for post approval changes

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Drug Substance Development

● Medicinal chemistry route rarely suitable for clinical supply manufacture ● Clinical supplies route(s) typically are new routes and these can be changed during development ● Key decision is when to identify and introduce the commercial manufacturing process and how different it will be to the clinical supplies route(s) ● Primary stability data planning for DS and DP often drives the timelines ● Registration dossier commitments only refer to the commercial manufacturing process

Medicinal Chemistry Route – Non-GMP (Pre-clinical) • Lab scale mg / g

Clinical Supplies Route(s) – Appropriate GMP (clinical supplies) • Kilo scale 1 – 10 Kg

Commercial Manufacturing Process – Full GMP • 100 Kg – several Tonnes

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