CRED Getting the CMC Dossier Right 2024

Learning Objectives: To gain an understanding of the different parts of module 3.2.P. To learn how to critically evaluate the data in module 3.2.P.

Scenario: You work in a regulatory department for a small generic pharmaceutical company, TOPRAgenerics. A product has been identified and is coming off patent in 5 years and your team have been tasked with advising what CMC data should be generated for a generic application. The product is a topical gel and has the active substance TOPEX. You now need to discuss what approach to take and present back what data would be needed. Consider the following:- This is a generic of an existing product, what information might you want and need to best develop and register a product that is a copy of one that is already on the market and what we would need to do to demonstrate that. Work methodically through the 3.2.P and what information you are going to need and where it can be made equivalent. Task: Firstly, select a member of the group to act as a representative for your regulatory department. They will be responsible for making the notes and reporting the findings to the rest of the groups. Establish what sections of the dossier we will need to focus on to demonstrate that we have a suitable product.