The PRIME scheme aims to support the development of novel medicines that target an unmet clinical need in conditions that are seriously debilitating or life-threatening. The scheme offers enhanced support to medicine developers to optimize the development of a medicine and expedite the achievement of a marketing authorization in the EU. The eligibility criteria for PRIME are set high, and the overall approval rate for PRIME sits at 25% of applications as of May 2022. To apply for PRIME, applicants must provide any available data showing a meaningful improvement in clinical outcomes, such as impacting the prevention, onset, and duration of a given condition or improving the morbidity or mortality of a disease. The new online platform offers pre-submission support to any applicant planning a PRIME application, including a virtual pre-submission meeting to discuss PRIME eligibility. The 2024 deadlines for submission and timetable for assessment for PRIME eligibility requests are available on the EMA website.
The PRIME scheme has several key benefits for applicants, including:
- Early appointment of CHMP or CAT rapporteur
- Kick-off meeting with rapporteur and multidisciplinary group of experts from EMA/European medicines regulatory network
- Appointment of PRIME Scientific Coordinator
- The iterative scientific guidance on major issues and overall development plans
- Shorter timelines and expedited follow-up scientific advice (under certain criteria)
- Meeting for submission readiness
- Confirmation of potential accelerated evaluation
When to apply
Any sponsor participating in the development process exploratory clinical trial stage may submit a request for enrolment into the PRIME scheme.
- This is based on the fact that there is preliminary clinical evidence available to show the drug’s promising activity and its potential to substantially address an unmet medical need or proof of concept
How to apply
- To submit a PRIME eligibility request, drug developers should use the secure online IRIS platform provided by the EMA
- The platform offers a centralized location for requests, communications, information sharing, and document delivery pertaining to a PRIME eligibility process from applicants and EMA
For more details visit the official website:
