Module 18 2021

07/02/2021

The level of information will depend on the Product  High ● A new chemical/biological product with limited experience, or a new delivery system/pharmaceutical form How much information to include in the CTD

 What about ● A basic solution for injection of a well established active substance?

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Drug Substance information

3 options for presenting drug substance information in the CTD Module 3.2.S. 1. Full information ● Populating all sections with relevant data 2. Active Substance Master File (ASMF)

● Applicants Part ● Restricted Part 3. European Pharmacopoeia Certificate of Suitability (CEP) ● Minimises information needed in the Module 3.2.S

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