Module 9 2024

03/09/2024

Module 3

• The Q, S & E data requirements for product approval submissions are presented in harmonised regulatory procedural guidance for the Common Technical Document, acceptable now in essentially all regulatory jurisdictions

• The ICH CTD guidance describing the core of a MAA or BLA dossier has clearly defined requirements for:

Structure

•

Format

•

Content

•

Granularity

•

• Relationships between sections

• The expectations of regulatory reviewers must be carefully matched, regardless of product class, and a successful filing is contingent on a clear understanding of how the file is put together

• An awareness of common deficiencies, notably for biological product submissions, is a first step in getting it right

The Organisation for Professionals in Regulatory Affairs

63

Development of Bioassays

Day 2: Lecture 7

With

Paula Urquhart

The Organisation for Professionals in Regulatory Affairs

64

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