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‘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...

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More from Europe

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

Denmark: QALY Brings HTA Transparency But Industry Wants More Willingness To Value Innovation

 
• By Francesca Bruce

Rare disease drugs with limited evidence are most likely to be awarded a negative reimbursement recommendation in Denmark following a QALY-based health technology assessment, finds an analysis from industry group LIF.

AI’s Attempt To Decode EU Pharma Reform Called A ‘Car Crash’

 
• By Eliza Slawther

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

More from Geography

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.