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EU Pharma Slams ICH Proposal For Selective Adoption Of Quality Guideline

 
• By Vibha Sharma

An unprecedented proposal by the International Council for Harmonisation that would let member states selectively adopt certain parts of one of its quality guidelines has drawn criticism from EU pharmaceutical industry associations.

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Allowing Regional Regulatory Interpretations Can Result In Divergence • Source: Shutterstock

A proposal by the International Council for Harmonisation that would allow ICH member states to "selectively adopt" certain parts of its draft Q12 guideline on managing post-approval changes has drawn strong criticism from EU pharmaceutical companies.

The ICH introduced this unprecedent proposal in the draft Q12 guideline after it became clear that some of the regulatory concepts described in the document – such as the use of explicit established conditions (ECs) and product lifecycle management (PLCM) – are not

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