New UK Drug Applications At ‘Sustained Levels’ Post-Brexit

MHRA Vaunts ‘Exciting’ New Operating Model

The MHRA’s chief executive explains to the Pink Sheet how the agency will ensure the UK remains an attractive place to seek approval of new innovative drugs and build on the regulatory flexibilities introduced during the COVID-19 pandemic.

Closeup of mobile phone screen with logo lettering of UK MHRA agency, serum vials and syringe background - Image ID: 2H94BWR
The UK MHRA is undergoing a period of change • Source: Alamy

The UK Medicines and Healthcare products Regulatory Agency has painted a positive picture of its post-Brexit performance, saying that new drug applications have remained at “sustained levels” since the UK left the EU, and that the number of clinical trials is “buoyant.”

The agency also has an “exciting new operating model” that includes a new Innovative Medicines team, while its new international...

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

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

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.

More from Geography

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

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.