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Major Review Of EU PRIME Scheme Highlights Faster Approvals

 
• By Neena Brizmohun

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.

Gene Therapy Concept
Potentially curative gene therapies have been developed under the PRIME scheme • Source: Alamy

PRIME, the European Medicines Agency’s scheme for the development of drugs for unmet medical needs, has had a positive impact in supporting the evaluation of EU marketing applications for such products and reducing the overall time to approval.

Marketing authorization applications (MAAs) for PRIME-supported products are more likely to be granted accelerated assessment by the EMA and maintain the fast-track

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