EU HTA Regulation: Joint Scientific Consultations Are An ‘Important Strategic Opportunity’

Manufacturers should make use of joint scientific consultations under the EU Health Technology Assessment Regulation, but they must pay close attention to the selection criteria as consultation slots are limited, experts say.

Joint scientific consultations can provide companies with advice on generating evidence for joint clinical assessments (Shutterstock)

Companies with products that will undergo an EU-level joint clinical assessment (JCA) have until 3 March if they want to apply for a joint scientific consultation (JSC), or scientific advice. While slots for JSCs will open again later this year, experts from pharmaceutical services provider Cencora, formerly known as AmerisourceBergen, are advising companies to make the most of this opportunity.

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 Health Technology Assessment

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

More from Geography

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.