How The EU Is Keeping Up With Innovation In Clinical Trials

New Guidance On Supporting Complex Clinical Trials Expected Before Summer

A senior EMA official says Europe has set the ball rolling on presenting a unified approach on clinical trial processes and strategic matters, and is taking steps to ensure there are no roadblocks.

 Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
EU wants to drive innovation in clinical trial methods • Source: Alamy

Regulators in the EU are aware that the global clinical trial landscape is evolving so quickly that recent reforms introduced by the Clinical Trial Regulation (CTR) and being delivered via the new Clinical Trial Information System (CTIS) are insufficient to ensure the region remains a desirable destination for clinical research.

This is why, just days before the CTR came into effect at the end of January this year, a new...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

More from Geography

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.