Accelerated Assessment Decision ‘Imminent’ For Two Products In EMA’s PRIME Scheme

The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.

airport runway under the sun as background
The EMA's PRIME scheme should speed time to market • Source: Shuttestock

Two of the investigational products in the European Medicines Agency’s priority medicines (PRIME) scheme for drugs for unmet medical need have now reached the stage where decisions are imminent on whether they will be accepted for review under the EU’s accelerated assessment procedure.

Jordi Llinares Garcia of the EMA revealed this development on May 19 at a meeting the agency hosted at its headquarters in London to mark the first anniversary of PRIME...

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

More from Geography

China NMPA Lays Out Regulatory Priorities At DIA

 
• By 

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By 

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.