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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 across the EU – is causing some concern as to whether the CTR will be effectively implemented Also see "EU

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• By Eliza Slawther

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• By Francesca Bruce

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

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EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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