Major Review Of EU PRIME Scheme Highlights Faster Approvals
Products developed under PRIME, the European Medicines Agency’s priority medicines scheme, are more likely to be granted accelerated assessment and maintain fast-track status than non-PRIME products, says a new report.
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A shortage of staff and expertise at regulatory agencies as well as tough eligibility criteria can impact expedited programs and their capacity to help deliver quicker access to innovative products.
After finding that products developed under the PRIME scheme frequently lost their accelerated status while they were being reviewed for potential EU marketing approval, the European Medicines Agency is looking into whether it should start holding “submission readiness” meetings.
The Europe Medicines Agency is reconsidering its rules governing at which stage of drug development it permits companies to enter its PRIME scheme, but it is not yet ready for the initiative to be used for extending the indications of already approved products.