EMA Ready To End Adaptive Pathways Pilot, Tap Into Lessons Learned
This article was originally published in The Pink Sheet Daily
"Successful" pilot project supports integrating concepts into existing regulatory frameworks, EMA official who coordinated it says.
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EMA official gives perspectives on how PRIME and adaptive pathways compare, and how they fit with other programs such as conditional authorization.
The EU's adaptive licensing pilot project, which was launched in March 2014, is designed to deliver an early centralized marketing license for promising innovative therapies for patients with serious or life-threatening conditions. However, while the benefits are clear, there are a number of challenges that will need to be addressed.
In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.