Priority Medicines Scheme - PRIME
What is it for?
PRIME aims to support the expedited development of medicines for an unmet medical need by an early dialogue with developers of promising medicines, to optimise development plans and speed up the evaluation so these medicines can reach the patients earlier. By engaging with medicine developers early on, PRIME is aimed at improving clinical trial designs so that the data generated is suitable for evaluating a marketing-authorisation application. Early dialogue and scientific advice also ensure that patients only participate in trials designed to provide the data necessary for an application, making the best use of limited resources. The service entails a meeting with the Committee for Medicinal Products for Human Use (CHMP) and from the Committee on Advanced Therapies (CAT). It provides scientific advice at key development milestones and formal written confirmation of PRIME eligibility and potential for accelerated assessment.
Who can apply?
This support service is open to any EIC beneficiary working on the development of medicines for an unmet clinical need. Academic and SMEs applicants can also apply at an early entry point by providing a sound pharmacological rationale, convincing scientific concept; relevant nonclinical effects of sufficiently large magnitude and duration; tolerability in first in man trials (no need of efficacy data).
How to apply?
Please submit the PRIME Applicant’s justification. the Pre-submission request form and the Literature references cited in the justification via Eudralink to prime@ema.europa.eu. The deadlines for the application can be found here. An SME needs to have received the SME status from EMA to benefit from this free service. Please check here to find out how to obtain it.
For more information on how to apply please check the Guidance to applicants seeking access prime scheme and this website.
Timeline and Cost
One can apply any time (no requirement on having an EIC project ongoing or having had one). The entire process from the validation of the application to completion takes ~40 days. PRIME is free of charge.
Testimonials
Please also read here and watch (from 3 h 19 min) the testimonial from the coordinator of the EIC Accelerator TREG project.
Learn more
To know more please watch here the recording of the EIC – EMA InfoDay: Regulatory support for the development of innovative medicines and technologies offered on 31/01/2023/. The presentation on Scientific Advice starts at 1 h 56 min. The slides of the presentation can be found here.
For more information please check Enhance early dialogue to facilitate accelerated assessment of PRIME and the PRIME website.
FAQ
FAQ on PRIME as part of those Qs asked during the EIC – EMA Info Day will be posted soon at the InfoDay event webpage.
Contact
EMA contact point: prime@ema.europa.eu or, alternatively, send a question to the European Medicines Agency.