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EU Sees Snags In Implementing ICH Guide On Post-Approval Changes

 
• By Vibha Sharma

EU authorities say the new tools and concepts needed for implementing the new international guideline on post-approval changes (ICH Q12) will be considered when the EU framework is reviewed. 

Two arrows pointed in different directions on a signpost 3D illustration
Parts of ICH Q12 Are Not Compatible With EU Legal Framework • Source: Shutterstock

Although EU authorities have formally adopted the International Council for Harmonisation’s controversial guideline on managing post-approval changes of medicines (ICH Q12), its practical implementation remains in limbo as certain aspects of the guideline are not compatible with the current EU legal framework.

In an explanatory note accompanying the adoption of ICH Q12 and related annexes, the European Commission and the European Medicines Agency point out that there are “some...

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