Module 9 2021

16/03/2021

Why is Module 3 important (cont.)?

• Module 3 applies equally through IMPD development up to licencing and beyond

• 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 also critical to lifecycle maintenance and future compliance

The Organisation for Professionals in Regulatory Affairs

5

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..)

• Ideally Module 3 of your MAA should be built from the last IMPD

The Organisation for Professionals in Regulatory Affairs

6

3