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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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In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
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Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

More from Geography

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.