EMA bioequivalence

November 18, 2013

The European Medicines Agency has released its first product-specific guidance on the demonstration of bioequivalence for 16 active substances. It’s the first wave of product-specific bioequivalence guidance, with the aim of enabling a consistent approach to the assessment of applications supported by bioequivalence data, particularly generic applications, across all authorisation routes. The guidance documents have been released for a three month public consultation - CL ICK HERE.

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Pharmacy Daily | EMA bioequivalence

EMA bioequivalence

Other recent headlines

PSA25 Excellence Awards announced

AD drug evidence bolstered

Pharmacists at the heart of health strategy

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES