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MEPs Pass Clinical Trials Laws But Implementation Will Be Troublesome

 
• By Faraz Kermani

Europe’s parliamentarians have unsurprisingly and overwhelmingly voted in favor of the Clinical Trials Regulation – but implementation and transparency problems hover on the horizon.

The European Parliament’s nod to the Clinical Trials Regulation late on April 2 clears the way for EU pharmaceutical manufacturers to benefit from faster approval timelines, while patients and clinicians will profit from increased transparency. Still, challenges remain, in terms of effective enforcement of the new laws affecting the bloc’s 28 member states, and diverse approaches to transparency.

Experiences gained from some member countries’ handling of the Transparency Directive − which was designed to regulate pricing and reimbursement...

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