1. Pink Sheet
  2. >>Pathways & Standards

A Breakthrough Therapies Pathway In Europe? Not Likely, Regulators Say

 
• By Kate Rawson

Drug companies looking for a FDA-style Breakthrough Therapies pathway in Europe shouldn’t hold their breath: The current European health care reimbursement landscape, regulators say, cannot support a Breakthrough pathway. Europe is looking for other ways to shorten drug development times until the bigger-picture reimbursement question can be addressed. Is adaptive licensing the answer?

The relationship between the Food & Drug Administration and its regulatory counterpart in Europe, the European Medicines Agency, could be characterized as a friendly competition between two peers.

FDA considers it a point of pride when new therapies are available to U.S. patients before other countries, and agency...

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 Approval Standards

More from Pathways & Standards