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 The European Medicines Agency's (EMA) initiative called PRIME, which
stands for PRIority MEdicines, is the latest example of regulators
on both sides of the Atlantic working to evaluate truly innovative
drugs more swiftly than in the past.
In the United States, the Food and Drug Administration has
introduced a successful "breakthrough" designation, which has
speeded up approval of innovative drugs for cancer and other serious
diseases.
The European agency said it expected around 100 applications a year
for its new PRIME scheme, which aims to foster better planning of
medicine development 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.
The move could help speed development and approval of treatments for
several conditions where there are few options at present, such as
rare cancers and Alzheimer’s disease. It may also help accelerate
commercialization of new classes of antibiotics, which are badly
needed given the rise of antimicrobial resistance.
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The EMA, which approves medicines for all EU countries, is based in
London's Canary Wharf financial district. However, its future in the
UK capital is uncertain if Britons vote to leave the European Union
in a June referendum.
(Reporting by Ben Hirschler; editing by Susan Thomas)
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