Module 9 2024

03/09/2024

General Structure of Module 3 (cont.)

• Module 3 is essentially broken down into key areas

Description of the substance/product

1. 2. 3. 4. 5. 6. 7.

Manufacturing Process

Characterisation of the substance/product Controls to test the final substance/product

Reference material/standards

Container closure

Stability

• Essentially the same for drug substance (3.2.S) and drug product (3.2.P) • Small molecules: option to refer to a Drug Master File/Active Substance Master File in place of or supporting 3.2.S (EU) – DMFs can be a viable option for other elements in other countries (e.g. US, China etc)

The Organisation for Professionals in Regulatory Affairs

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Specific Module 3 Components

• Will not go through all Module 3 components

• Focus on key Module 3 sections for Active Substances & Products

• Placebos, Non investigational Medicinal Products (NIMPs), comparators are similar but different • Much of the basic content is currently defined for commercial products in ICH M4Q and for clinical products through regional guidance • Medical Devices continues to be a hot topic around how to position dossier components – especially following introduction of the EU Medical Device regulation and the increasing role of Notified Bodies

The Organisation for Professionals in Regulatory Affairs

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