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.



Posted on the EMA website on 26 October 2015