Concept paper on development of product-specific guidance on demonstration of bioequivalence released for a two-month public consultation

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01/08/2013

Concept paper on development of product-specific guidance on demonstration of bioequivalence released for a two-month public consultation

The European Medicines Agency has released a draft concept paper on the development of product-specific guidance on demonstration of bioequivalence for a two-month public consultation.

Comments should be made using the submission form and sent no later than 30 September 2013 to pkwpsecretariat@ema.europa.eu.

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.

This product-specific guidance will be based on the general principles set out in the Agency’s overarching guideline on the investigation of bioequivalence. This general guideline specifies the requirements for the design, conduct, and evaluation of bioequivalence studies.

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