Further detailed discussion ahead for draft EU Clinical Trials Regulation

The earliest vote on the proposed Clinical Trial Regulation has now been deferred until March 2014 – a necessary delay as stakeholders have drilled down into the detail of the proposals intending to streamline medicines development in the EU as speakers at the TOPRA Annual Symposium in Lisbon, Portugal, explained to an audience of around 400 regulatory professionals.

The proposed regulation comes 10 years after the original Clinical Trials Directive which enshrined Good Clinical Practice and set out to harmonise the approval and conduct of clinical trials throughout the EU. Rather than a streamlined European process as intended, varying interpretations of the Directive among member states resulted in many different approaches. According to Ingrid Kössler from the European Economic and Social Committee (EESC), in Sweden, the Directive has become the most criticised one in the EU. Rather than cutting times to implementing clinical trials, for example, the time to launch has increased by 90% to 150 days.

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