The Pharmaceutical Journal
Vol 275 No 7357 p40
9 July 2005

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EMEA guideline procedures

Procedures intended to lead to transparency in the development, consultation, finalisation and implementation of guidelines based on European pharmaceutical law have been set by the European Medicines Agency (EMEA).

Guidelines are produced so that pharmaceutical companies know what they are expected to take into account in the research and development of new medicines. The production of such guidelines is a central part of the EMEA’s work in the EU pharmaceutical regulatory system. Many of them arise from harmonisation activities with Japan, the US and other international partners.

The new procedure is part of the EMEA’s response to a transparency consultation exercise carried out in 2003. A draft version was released for consultation in September 2004 and the responses received from 15 organisations and individuals have been published on the EMEA website as a PDF file (300K).

The new procedure will come into effect for all draft and final guidelines published by the EMEA after 1 September.