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New Rules for Clinical Trials Proposed in Europe by Peter W.L. Bogaert
Covington & Burling LLP - Brussels Office
Grant H. Castle
Covington & Burling LLP - London Office
Genevieve Michaux
Covington & Burling LLP - Brussels Office
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August 2, 2012
Previously published on August 1, 2012
On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated by the pharmaceutical industry, academia, and patients for years. Directive 2001/20/EC aims at harmonising the requirements throughout the EU but has not prevented divergent national requirements that, especially for multinational clinical trials, substantially hinder a swift handling of clinical trial applications and generate a very burdensome and costly administration. The Proposal primarily seeks to cut the red tape and to facilitate the conduct of multinational trials and restore competitiveness in clinical research in Europe.
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