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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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

Photo of Grant Castle Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.