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Lack Of Harmonization In ICH Q12 Draft Guideline Draws Fire In US

 
• By Joanne S. Eglovitch

Major pharmaceutical industry groups in the US, like their counterparts in the EU, are concerned that the draft ICH Q12 guideline does not align with the established legal framework in certain ICH regions, including the EU, in terms of implementing key concepts such as established conditions and product lifecycle management.

Businessman sinking in heap of documents and asking for help

Major pharmaceutical industry groups in the US say that while they support in principle many of the core principles of the draft ICH Q12 guideline on lifecycle management and post-approval changes, they are concerned about its implementation, and about its incompatibility with the established legal framework in certain ICH regions, including the EU.

They complain that not having a global framework for some core concepts of ICH Q12 like established conditions (ECs) and...

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