Module 9 2021

For biologicals in particular

The journey has reached a destination at which:

• Precedent hazards and their risks of occurrence have been characterised – They have been eliminated, or – They can be mitigated

• Known potential hazards can be mitigated

• Harmonised regulatory guidance is in place – Applied on a case by case basis

• Key aspects addressed by guidance – Quality – Safety

The Organisation for Professionals in Regulatory Affairs

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For biologicals in particular • 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

Module 3 Guidelines & Requirements Richard Keene

The Organisation for Professionals in Regulatory Affairs

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