UK MHRA Calls On Pharma To Embrace RWD Early

The UK’s MHRA is urging drug companies to engage in discussions on their strategies relating to using real-world data earlier in their development cycle.

The MHRA's Alison Cave at the BIA conference this month (Pink Sheet)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is encouraging companies to “spread the word, have ideas and come talk” about their real-world evidence (RWE) strategies, with the aim of moving these discussions to earlier stages of the drug development cycle.

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 Conferences

Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 

While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

UK Health Secretary Admits VPAG ‘More Expensive’ Than Expected & Needs To Be ‘Resolved’

 

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

More from Geography

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By 

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By 

PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By 

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.