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Differences Put Aside As ICH Finalizes Guide On Post Approval Changes

Final Q12 Document Adopted At Singapore Meeting

 
• By Vibha Sharma

An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.

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ICH Q12 Will Promote Continual Improvement In Pharma Sector • Source: Shutterstock

The International Council for Harmonisation has finalized three key guidelines at its latest meeting in Singapore, including the highly-debated quality guideline (ICH Q12) on lifecycle management of post approval changes.

The other two guidelines that have been finalized are the ICH E9(R1) addendum to defining the appropriate estimand for a clinical trial/sensitivity analyses, and the ICH M9 guideline on biopharmaceutics...

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