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"Work to Be Done" on EU Clinical Trials Regulation, Says Industry


Pharmaceutical Executive

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation.

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from  trial study reports should not be considered commercially confidential.

The Regulation also requires, among other things, that

  • all drug trials in Europe are registered on the publicly accessible EU clinical trials register

  •  a summary of the results - “understandable to a lay person” - from these trials is published on the register within a year of the trial’s end

  • Clinical Study Reports are be made publicly available, and that

  • a new, publicly accessible EU clinical trials register is set up and run by the European Medicines Agency (EMA).

The European pharma industry association, EFPIA, welcomed the vote, but said the Regulation’s revision objectives have been only partially achieved. In a press statement, EFPIA commented: “[It] is critical that the Commission and EMA interpret the Clinical Trial Regulation in a manner that respects patient privacy, the integrity of regulatory decision-making, and incentives for companies to make long-term investments in biomedical research.”

Richard Bergstrom, EFPIA’s Director General, added: “There is still work to be done. The success of this legislation will depend on how it is applied in practice.” For EFPIA, this means how the legislation is implemented at member state level, so that collaboration between ethics committees is promoted and clinical trial applications are assessed in the shortest time possible.

A key pillar of success will be the efficient operation of the EMA’s European Clinical Trials Database, says EFPIA, who are calling for the portal and database to be fully operational within the mandated timeline.

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