Europe Launches Fast-Approval Drug Plan
On the heels of the U.S. Food and Drug Administration’s successful "breakthrough" designation, which has speeded up approval of innovative drugs for cancer and other serious diseases, comes news that European regulators have followed suit.
On Monday they launched a new plan to speed the approval of promising new drugs, and address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials.
The European Medicines Agency's (EMA) initiative is called PRIME -- which stands for PRIority MEdicines. It’s the latest example of regulators on both sides of the Atlantic working to evaluate truly innovative drugs more swiftly than in the past.
The program’s administrators expect around 100 applications a year. They are determined to foster better planning of medicine development, and to help companies generate the data needed for approval more rapidly. Experimental drugs accepted into the program will get continuous support from an EMA expert, who will be appointed early in the process and provide guidance on overall development plans and regulatory strategy.
This development could help speed approval of treatments for several conditions where there are few options at present, such as rare cancers and Alzheimer’s disease.