Module 9 2024

03/09/2024

Module 3 Level of Detail

• The level of detail registered in your Module 3 is critical

• There is no “one size fits all” model

• The ideal scenario would be to register the minimal amount of information while providing sufficient information for regulators • This needs to be balanced with clearly defined requirements in legislation, guidance and current regulatory expectations • There is also a balance to be struck between regulatory and Good Manufacturing Practice requirements in Module 3 (e.g. shipping, room classifications etc) • Currently can be very difficult to maintain a consistent level of detail globally at the IMPD stage although EU CTR is helping harmonisation for EU countries

The Organisation for Professionals in Regulatory Affairs

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General Structure of Module 3

• First point of reference for an EU MAA should be Notice to Applicants Volume 2B, CTD – Module 3 and increasingly EMA pre-/post authorisation guidance and Q&A

• Provides guidance on the format required for a registration application

• Provides specific guidance for different modalities and product types

For the EU also consider:

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Ph. Eur. – has a legal basis

•

• Scientific guidelines - while not legal requirements deviation from these must typically be strongly justified • Q&As – driving new requirements and expectations

The Organisation for Professionals in Regulatory Affairs

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