EMA Concept paper on bioequivalence

The European Medicines Agency (EMA) have issued a concept paper on ‘Development of product-specific guidance on demonstration of bioequivalence’.

According to the EMA: “Bioequivalence studies are conducted, amongst others, as part of the development of generic medicines to demonstrate that they are bioequivalent to the reference medicine. The aim of developing product-specific guidance is to enable a consistent approach to the assessment of applications based on bioequivalence data across all submission routes, i.e. the centralised, decentralised, mutual-recognition and national procedures. The guidance is intended to help companies design study programmes that meet the expectations of European Union regulators, allowing for better transparency and predictability of the scientific assessment during the authorisation process.”

For further details see: EMA

Posted by Tim Sandle