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EMA Bolsters PRIME Scheme With Improvements

 
• By Neena Brizmohun

The European Medicines Agency will hold submission readiness meetings with the sponsors of products in the priority medicines scheme around a year ahead of them submitting their marketing authorization applications for regulatory review.

The way forward railway
The PRIME scheme is designed to get medicines for unmet medical needs to patients faster • Source: Shutterstock

The European Medicines Agency is implementing improvements to its PRIME (priority medicines) scheme – introducing a regulatory roadmap and product development tracker, providing expedited scientific advice, and holding submission readiness meetings to help avoid the submission of premature marketing applications.

PRIME was launched in 2016 to help speed up the development and regulatory review of medicines for unmet medical needs...

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