Originally published as Covington E-Alert on August 1st, 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.

The future Regulation will be more complete and detailed than Directive 2001/20/EC (more than 90 articles and five annexes) and will revise current rules, in particular as regards the authorisation procedures, and introduce new principles, such as co-sponsoring. Overall, the new regime should reduce administrative costs for industry and better reflect the variety of clinical trials. The Commission chose a Regulation as legislative instrument to ensure that identical rules will apply throughout European Union. This will increase harmonisation of the rules, but certain issues, such as ethics and sponsor liability, will remain governed by national law.

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