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.
EMA Bolsters PRIME Scheme With Improvements
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.
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