Report: New EU Clinical Trials Regulations to Come As Early as Next Week

Posted 10 July 2012 | By

European Commissioner for Health and Consumers John Dalli plans to introduce new clinical trials legislation as early as 17 July 2012, reports Reuters.

The legislation, previewed at a 27 June meeting in Washington, DC, is in response to what Dalli referred to as a "decline in clinical research in the EU." The EU has seen a 25% decline in the number of clinical trials conducted in the EU between 2007 and 2011, though Dalli hedged that the decline was not exclusively due to the existence of the 2001 Clinical Trials Directive.

"Let me be clear - the Clinical Trials legislation was not the only reason behind the decline in clinical research in the EU," Dalli said, citing the availability of venture capital and industry's declining productivity as two other factors.

At the time, Dalli said he would be looking to balance the speed at which products are able to be used by consumers and the ability of EU regulators to conduct safety assessments of products using complete data. "Whatever the financial situation, patient safety must always come first," concluded Dalli.

A Harmonized, EU-wide Approach to Registration

Dalli said the new rules will aim to take into account the increasing number of clinical trials being conducted abroad, including multi-country trials. Reuters explains the current rules require clinical trial applications to be submitted separately to all member states in which the trial is set to be conducted-a time-consuming process that can add considerable cost to a drug's development.

Under the new rules proposed by Dalli, the EU would move to a harmonized, EU-wide approach to clinical trials registration. The 2001 Clinical Trials Directive would be scrapped and replaced with an EU-wide regulation. Reuters notes this process would involve each EU member state individually ratifying the proposal, which could take several years to complete.

Read more:

Reuters - EU set to simplify clinical trial rules

Regulatory Focus - EC's Dalli Proposes New EU Clinical Trials Legislation


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