Improving bioequivalence studies

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15/07/2015

Improving bioequivalence studies

EMA consults on a new batch of specific guidance for four active substances

The European Medicines Agency (EMA) has released for consultation product-specific guidance on bioequivalence studies for four active substances: asenapine, prasugrel, sitagliptin and zonisamide.

This follows the finalisation of bioequivalence guidance which covered 16 active substances in 2014 and 2015.

Comments on the draft guidance documents should be made using the form provided and sent to pkwp@ema.europa.eu no later than 1 November 2015.

As part of the development of generic medicines, companies need to demonstrate that the generic and the reference product are bioequivalent, which means that, under similar conditions, they release the same active ingredient into the body at the same rate and level. This is done through bioequivalence studies. Such studies can also be required for example for applications for variations of a marketing authorisation, fixed-dose combinations, extensions of indication and hybrid applications.

EMA has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the EU, i.e. the centralised procedure via EMA, and the decentralised, mutual-recognition and national authorisation procedures via the national competent authorities. These guidance documents describe the specific requirements for the demonstration of bioequivalence for each active substance.

This initiative aims to help companies design study programmes that meet the expectations of European Union (EU) regulators and allows better predictability of the scientific assessment.

EMA intends to release product-specific bioequivalence guidance for new substances twice a year.

Companies should consult the EMA webpage Product-specific bioequivalence guidance to find out about the newly released guidance.

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