EMA consults on bioequivalence guidance

Published: 30-Aug-2013
Regulatory

Would help create a consistent approach to applications based on bioequivalence data


The European Medicines Agency (EMA) is consulting pharma companies on a concept paper explaining how it might release product-specific guidance on demonstration of bioequivalence. This can show, for instance, that generic medicines are the same as branded reference medicines.

Product-specific guidance would help create a 'consistent approach to…applications based on bioequivalence data,' said EMA.

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