PRIME is a European Medicines Agency (EMA) initiative to increase assistance for the development of medicines that address an unmet medical need.
Through PRIME, the Agency provides early and proactive support to drug developers to maximise the production of reliable data on a medicine’s benefits and risks and to allow accelerated assessment of drug applications.
PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. Developers of a medicine that benefited from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation.
Key benefits for applicants
- Early CHMP or CAT rapporteur appointment
- 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
The PRIME programme focuses on developing drugs that are not yet approved in the EU. They focus on diseases for which there is either no available treatment or where they can provide a significant therapeutic advantage over current therapies.
A medicine must demonstrate the ability to significantly address an unmet medical need to be accepted for PRIME. This might entail, for instance, developing brand-new therapeutic techniques or enhancing current ones.
Applications must be supported by any data that can demonstrate a meaningful improvement in clinical outcomes, such as:
- Having an effect on the prevention, onset, and course of a specific condition.
- Decreasing a disease’s morbidity or mortality.
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 centralised location for requests, communications, information sharing, and document delivery pertaining to a PRIME eligibility process from applicants and EMA.
- For more details –