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EU Commission Proposes Simpler Rules for Clinical Trials

by JMC on July 25, 2012

The European Commission has put forward a new set of rules designed to make it easier to conduct clinical trials.

At present, pharmaceutical companies often face difficulties when trying to carry out cross-border trials. The proposals – which will replace 2001’s Clinical Trials Directive – aim to cut red tape and costs for pharmaceutical companies by speeding up and simplifying authorisation and reporting procedures. This in turn should make Europe more attractive to researchers, with the bloc recording a 25 per cent decrease in clinical trials between 2007 and 2011.

John Dalli, European commissioner for health and consumer policy, observed that clinical research is “crucial” for developing new medicines and improving existing ones. “Today’s proposal significantly facilitates the management of clinical trials, while maintaining the highest standards of patient safety and the robustness and reliability of trial data. “£640 million (€800 million) per year could be saved in regulatory costs. All this will boost research and development in the EU, thus contributing to economic growth.”

Industry groups have welcomed the proposals, with Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, saying they provide “a unique opportunity to create a competitive European medical research environment”. He remarked: “Recent years have seen a significant decrease in the number of clinical trials conducted in Europe, this has to stop if we want Europe to continue to play a leading role in medical research.”

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