The procedures, eligibilities and goals of EMA’s accelerated access approaches for new medicines that fill unmet medical needs, including “Priority Medicines” (PRIME) and “Adaptive Pathways” (AP), have been taking more concrete shape, informed by the European agency’s growing implementation experience.
Since March 2016, there has been a wave of EMA releases on the different facets of its effort to give enhanced support for the development and approval of qualifying new medicines. The releases provide insight into the interrelationships between the components of the effort, and where the agency and industry are in implementing them.
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