Module 9 2024

03/09/2024

Why is Module 3 Important (cont.)?

• Module 3 applies equally through IMPD development up to licencing and into the lifecycle • Getting Module 3 into a suitable state is not simply a case of “dumping all CMC information into a defined format” • Your Module 3 must coherently tell the story of the development while ensuring that continued compliance of your CMC elements are well defined

• Getting Module 3 approved is a requirement for your CTA/MAA but;

• Getting an appropriate Module 3 approved is absolutely critical to lifecycle maintenance and future compliance

The Organisation for Professionals in Regulatory Affairs

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Evolution of Module 3 Alongside Product Development

• Your Module 3 content should evolve and build as your product is developed

• Phase specific expectations are defined in EU IMPD guidance (e.g. biologics, impurities etc..) but expectations evolve over time

• In an ideal world Module 3 of your MAA should be built from the last IMPD/IND

The Organisation for Professionals in Regulatory Affairs

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