Module 9 2021

16/03/2021

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 or hold times) • Currently can be very difficult to maintain a consistent level of detail globally at the IMPD stage (e.g. EU National CTA Assessments) • In time it is hoped that EU CTR and ICH Q12 once fully implemented may help

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 biologics and small molecules • For the EU also consider: ● 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

The Organisation for Professionals in Regulatory Affairs

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