EU/FDA 5TH BILATERAL CONCORD REACHED

13 December 1993

Representatives of the European Union (formerly designated the European Community) Directorate for Industry (DG 111) and the US Food and Drug Administration held their fifth bilateral meeting last month, covering human and veterinary medicines and food products. The meetings, started in 1989, provide a forum for discussion of matters of mutual interest and concern on the technical aspects of regulation and the identification of practical areas for the harmonization of regulations.

Discussions centered on issues such as recent and anticipated regulatory developments like the setting up within Europe of the new medicines agency, the European Medicines Evaluation Agency (which will be operated out of London, UK; Marketletter November 9), recent initiatives undertaken in the USA to improve consumer information in respect of food and medicines, and measures undertaken to guarantee the integrity of data submitted for regulatory purposes and the issuance of new regulations in the USA designed to facilitate the sharing with foreign governments of confidential commercial information of the type found in applications for approval.

Also reviewed were international harmonization activities, as discussed at the Orlando International Conference on Harmonization meeting (Marketletter November 15) last month, and specific issues relating to the development of biotechnology and the appropriate basis for new regulation.

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