CRED Getting the CMC Dossier Right 2024

05/09/2024

What Changes could have a serious impact?

• Pharmaceutical Form* – Capsule to Tablet, Plain to Film Coated Tablet

• Immediate Release to Modified Release*

• Major changes to Formulation – Comparative bioavailability study and multi-media dissolution comparisons, and biowaiver request

• Changes to Injectable Formulation – Further compatibility studies

• Changes to Locally Applied, Locally Acting products *: extensive pharmaceutical comparison or therapeutic equivalence studies

• Packaging changes – further stability studies

*Always consider getting scientific advice if significant changes could lead to need for additional pharmacodynamic/therapeutic clinical studies

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Product Lifecycle

EMA EMEA-H-19984/03, 21 June 2024 European Medicines Agency post-authorisation procedural advice for users of the centralised procedure Many ICH Guidelines are very useful for the initial submissions e.g. Stability Guidelines and Product Development

Look for opportunities to include:

1. Post Approval Change Management Protocols (already available in US and Europe) 2. Use ICH Q12 tools to provide more detail in the dossier on how future changes could be assessed

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