In the previous year the European Medicines Agency (EMA) set up a public consultation to develop a scheme to optimize the development and accelerated assessment of medicines of major public health interest. 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 is characterized by enhanced interaction and early dialogue with medicine developers and the EMA.
The EMA has thus launched PRIME, where a medication can be chosen to benefit from this scheme, based on the unmet medical needs it fulfills and on early clinical data that the said medication produces. 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.