EGA Press Release

Tuesday, 1 June 2010 - London

3RD EGA BIOEQUIVALENCE FORUM IN LONDON CONTINUES SUCCESSFUL COOPERATION WITH THE EU MEDICINES AUTHORITIES ON EU GUIDELINES

The EGA’s 3rd Bioequivalence Forum is set to focus exclusively on the revised Guideline on the Investigation of Bioequivalence http://www.ema.europa.eu/pdfs/human/qwp/140198enrev1fin.pdf. Delegates will gain informative insight into the interpretation and practical implementation of the new provisions in the revised guideline from a variety of high-level speakers. These include: European pharmacokinetcs assessors, representatives from the Co-ordination Group for Mutual Recognition & Decentralised Procedures (human medicines) the CMD(h), and bioequivalence experts from the generic medicines industry.

Bioequivalence is the key to ensuring safe and effective generic medicines. The EGA welcomes this opportunity for enhanced co-operation with the CMD(h) and the EU regulatory network in this important field. Discussions between 160 delegates and representatives from national and EU medicines authorities will offer an important opportunity to harmonise the interpretation of the revised guideline among European assessors and to enhance understanding by the industry.

Early dialogue with the industry on the draft guideline, published on 21 August 2008, resulted in significant improvement of the final version published in February 2010. It offers a more robust set of criteria by which to assess the applications made for generic medicines but increases assurance regarding the acceptance of their applications and reduces the amount of time the authorities need to debate borderline issues.

Key improvements offer clarification on many study design issues, including the inclusion of a scaled approach for highly variable drugs. With the acceptability of two stage design studies and the combining of study data now added, this ensures that data generated is used to its maximum effectiveness, whilst shielding people from exposure to unnecessary clinical intervention. Robust rules on precisely what data can be used will ensure a common interpretation of outcome across the industry and all the EU competent authorities.

We hope this will lead to further helpful clarifications on other aspects relating to bio-analysis and the bioequivalence of modified release products. However to increase the predictability of further Marketing Authorisation procedures, clarification how to deal with on-going studies and MA applications is still required.

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For further information contact Julie Maréchal-Jamil
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