Draft reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)

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Download document Draft reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)
Reference number EMA/CHMP/57760/2015
Status draft: consultation closed
First published 2015-10-26
Last updated 2015-10-26

Summary

The reflection paper has been developed to provide an overview of the accelerated assessment of priority medicines (PRIME) scheme proposed to reinforce early dialogue and regulatory support to stimulate innovation, optimise development and enable accelerated assessment of new medicines addressing major public health needs within the current regulatory framework. It includes details on eligibility criteria and procedural aspects to enter the scheme as well as incentives offered to eligible products throughout the development.