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

‘Faster Global Drug Approval’ Possible Under EMA’s Extended Reliance Framework

 
• By Neena Brizmohun

Drugs for Alzheimer’s disease, amyotrophic lateral sclerosis and other high unmet medical needs are among the new products that will now be eligible for assessment under the OPEN framework, the European Medicines Agency’s initiative for collaboratively assessing marketing applications with non-EU regulators.

collaboration
Regulatory collaboration can also help align post-approval lifecycle management for drugs • Source: Shutterstock

The OPEN framework that the European Medicines Agency started running in 2020 to allow international regulators to participate in its evaluation of EU marketing applications for COVID-19 vaccines and therapeutics has been extended to cover products in other therapeutic areas, including those targeting antimicrobial resistance (AMR).

Medicines that address a high unmet medical need, including some of those designated under the EMA’s PRIME scheme, will also...

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

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 
• By Eliza Slawther

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

More from Geography