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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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UK Needs Specialist Scientific Knowledge To Stay Competitive Post-Brexit, AstraZeneca Says

 
• By Eliza Slawther

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Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 
• By Neena Brizmohun

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

UK Targets Contamination Tests & Pharmacokinetic Studies In Animal Testing Phase Out

 
• By Eliza Slawther

Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.

EU Moment Of Truth For Teplizumab, Etuvetidigene Autotemcel & Other Drugs

 
• By Neena Brizmohun

The sponsors of a number of drugs could this week learn whether the European Medicines Agency will recommend in favor of approving their products. And while teplizumab was approved in the US in 2022, Sanofi told the Pink Sheet why it waited to submit the drug for regulatory review in the EU.

More from Geography

‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change

Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.

Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 
• By Neena Brizmohun

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

Hope For Stability, Credibility As US FDA Vet Pazdur Takes Over CDER

 
• By Sarah Karlin-Smith

The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.