EMA launches Priority Medicines Scheme
In the previous year the European Medicines Agency (EMA) set up a public consultation to develop a scheme to optimise the development and accelerated assessment of medicines of major public health interest (Read in OrphaNews). It was developed in consultation with the Agency's scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients (STAMP) as well as the European medicines regulatory network. This scheme for priority medicines was called PRIME) and is based on enhanced interaction and early dialogue with medicine developers.
The EMA has launched PRIME where a medicine is chosen to benefit from it based on its benefit patients with unmet medical needs based on early clinical data. The EMA encourages applicants from the academic sector and micro-, small- and medium-sized enterprises (SMEs), who can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. Companies can also request fee waivers for scientific advice.
The EMA has outlined the process once a candidate medicine has been selected for PRIME which is described in detail on their website.
For more information
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