EGA Press Release

Wednesday , 08 October 2008

2nd EGA Bioequivalence Forum in Paris Continues Successful Cooperation
with EU Medicines Authorities on EU Guidelines

Following on from last year’s highly successful event in Lisbon, the EGA is holding its 2nd Bioequivalence Forum today in Paris in cooperation with the Co-ordination Group for Mutual Recognition & Decentralised Procedures for human medicines—the CMD(h).

This year’s Forum, organised under the title “Bioequivalence guideline revision, regulatory procedures and good practices: paving the way towards an even more efficient regulatory framework”, has attracted more than 140 participants from the generic medicines industry and the national and EU medicines authorities. The CMD(h) is participating with the European generic medicines industry in this joint effort to develop and improve the interpretation of guidelines and standards within the bioequivalence arena.

Bioequivalence is the key to ensuring safe and effective generic medicines. A generic medicine and its reference product are considered to be bioequivalent when the appropriate bioequivalence study(ies) demonstrate(s) that the two formulations have a similar rate and extent of absorption of the medicinal product in the human body (bioavailability). This ensures comparable in vivo performance in terms of quality, safety and efficacy for both medicinal products.

The EGA welcomes this opportunity for enhanced co-operation with the CMD(h) and the EU regulatory network in this important field, particularly as it will allow for an early, one-to-one dialogue on the key aspects of the consultation document released to the public on 21 August 2008 with a view to establishing a revised Guideline on Bioequivalence for the European Union (www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf). An entire session of the full-day event will be dedicated solely to the new guideline. A lively, interactive exchange will be fostered through an informal question and answer format. Throughout the day, each topic will be introduced by an expert speaker and the discussion will led by a panel of invited speakers from regulatory authorities and the generic medicines industry, with full participation from all attendees encouraged in a round-table discussion format.

The main topics of discussion on this year’s programme include:

• Data Integrity, GCP and GLP Inspections,
• Early and Late Dialogue with Authorities from Scientific Advice to Referrals,
• Outcome of the Revision of the Bioequivalence Guideline,
• Guidance for the Development of Locally acting Products (dermatological and ophthalmic medical preparations, GI tract medicines).

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