EU Pharma Alarmed By Regional Variations In ICH's Draft Biowaiver Guideline

 
• By Vibha Sharma

European drug companies have expressed concern over region-specific requirements variations permitted in an ICH guideline that proposes a harmonized approach to granting waivers for in vivo bioequivalence studies.

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EFPIA says a disharmonized approach will defeat ICH's harmonization goal • Source: Shutterstock

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