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

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