EMA’s PRIME A Year On: Hits And Misses When It Comes To Applications
Three out of four applications have been denied entry to the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. Robert Hemmings, who chairs the EMA’s scientific advice working party, explains why.
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With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other support services, and are also proving to be keen users of the agency’s priority medicines scheme (PRIME), accounting for half of all PRIME applications in 2016.
Companies won’t necessarily lose their place on the European Medicines Agency’s priority medicines scheme if a competing product gets to market first. And they shouldn’t be put off by the fact that competing products are already on the scheme.