Nordic HTA Initiative Offers ‘Practice Ground’ For Worrisome EU-Level Joint Clinical Assessment

Industry shoulders some blame for growing unease about joint clinical assessments after its failure to participate in pilots.

NORDIC FLAGS
Nordic countries offer companies the chance to prepare for EU joint clinical assessments • Source: Shutterstock

Concern continues to grow among industry and health technology assessment (HTA) bodies about the imminent EU-wide joint clinical assessments. However, if companies want to increase their chances of readiness for the challenges ahead, they should consider submitting a dossier through the Joint Nordic HTA-Bodies (JNHB) initiative to get a taste of how the collaborative assessment process might work.

This was the message from Anja Schiel and Karen Kleberg Hansen, from the Norwegian Medical Products Agency and the Danish...

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

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By 

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

More from Geography

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.