1. Pink Sheet
  2. >>Geography
  3. >>Europe

EU Council Agrees Compromise Position On Joint Clinical Assessments

Industry Split On Whether It’s Progress Or A Letdown

 
• By Francesca Bruce

The Alliance For Regenerative Medicines is calling for advanced therapies to be given greater priority where joint clinical assessments are concerned.

Vector of business people sitting at target table brainstorming idea
Council of the EU is ready to negotiate proposals for HTA Legislation • Source: Shutterstock

The Council of the European Union has finally agreed its negotiating position on the European Commission’s proposals to introduce new legislation that would boost cooperation on health technology assessments across the EU.

One pharmaceutical industry source following the debate said the council’s position showed “a lack of trust” that could undermine a...

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
Start Free Trial

Already a subscriber?

More from Europe

EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

More from Geography

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
• By Tim Casey

Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
• By Sue Sutter

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.