The European Medicines Agency has released its draft concept paper on the development of development of product-specific guidance on demonstration of bioequivalence. Public comments are open until September 30.
EMA plans to develop product-specific guidance to enable a consistent approach to the assessment of applications based on bioequivalence data across various submission routes to help companies design study programs that meet European Union regulations. The guidance will be based on EMA’s guideline on the investigation of bioequivalence.
Source: European Medicines Agency