Snapshot

The PRIME (PRIority MEdicines) pathway has been developed by the European Medicines Agency of EU-EMA.

This pathway can be used where The EMA launched the PRIME scheme on 7 March 2016 to provide early and “enhanced” scientific and regulatory support to medicines for unmet medical needs. This voluntary scheme is based on early, proactive, and supportive interaction and communication between the EMA and developers to optimize development plans and speed up evaluation so therapies can reach patients earlier. Specifically, the agency offers support to developers to optimize generation of robust benefit-risk data and enable accelerated assessment of applications. PRIME builds on existing regulatory framework and tools, including scientific advice and the accelerated assessment option. Eligibility: Any sponsor who is in the exploratory clinical trial phase of drug development can apply for entrance to the PRIME scheme. Eligibility will be determined based on availability of preliminary clinical evidence in patients indicating the promising activity of the medicinal product and its potential to address an unmet medical need, that is, proof of concept. Applicants from academia and micro-, small-, and medium-sized enterprises may submit an eligibility request at an earlier stage of development if they can support the request with “compelling” nonclinical data in a relevant model; early evidence of possible promising activity (proof of principle); and data from first-in-human studies indicating adequate exposure for the intended pharmacotherapeutic effects and tolerability of the therapy..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: EU-EMA

60 days