UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU

Changes Represent Biggest Overhaul In UK Clinical Trials Regulation In Over 20 Years

The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.

United Kingdom (UK) science development concept - microscope on flag background.
UK Is Keen To Attract More Clinical Trial Activity • Source: Shutterstock

The UK government has announced much-awaited reforms to its clinical trials framework, explaining how several existing provisions will be soon replaced with new legislation or guidance. The changes, the government says, will make it faster and easier to gain approval and to run clinical trials in the country.

Under the new framework, the clinical trials application processes will be more proportionate, streamlined and flexible, without compromising on safety....

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 United Kingdom

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By 

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By 

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Not Over Yet: Eisai And Lilly To Appeal England’s ‘Flawed’ Refusal To Fund Leqembi And Kisunla

 

Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.

More from Europe

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By 

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.