The ICH has released a draft consolidated guideline (ICH Q1) that unifies the previous Q1A–Q1F series into a single global standard. This revision simplifies stability requirements, integrates lifecycle management, and expands the scope to advanced therapies and drug-device combinations.

 

This whitepaper provides a clear overview of the key changes — from predictive tools and modeling to stability expectations for ATMPs and critical auxiliary materials.

 

Download the full whitepaper to explore how the new guideline impacts your development and regulatory strategy

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