EU PRIME Scheme for priority medicines
What is the EU PRIME Scheme
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines targeting unmet medical needs. It is based on early dialogue with companies to optimise development plans and speed up evaluation. The aim is to reduce the time to patient access for transformative medicines, where there is significant unmet need.
PRIME does not replace the normal authorisation route, but it provides enhanced interaction and support during development.
Eligibility
The PRIME scheme focuses on medicines under development that are not yet authorised in the EU.
The Medicinal product in development must respond to the following criteria:
- Serious unmet medical need, particularly where current treatments are limited or inadequate
- Therapeutic advantage over existing options
- Innovation: the scheme is intended for medicines with a strong element of therapeutic innovation
- Potential to offer benefit to patients, with meaningful improvement of clinical outcomes
However, PRIME is not the right support vehicle for products that are already:
- in advanced development stages;
- in the pre-submission phase of a marketing authorisation application;
- authorised in the EU, where a new indication is sought.
Details on the PRIME application process
Typical timing for application is generally expected during the exploratory clinical trial phase, once there is preliminary clinical evidence supporting the medicine’s potential.
Earlier access is possible for some applicants: Small and medium-sized enterprises and academic sponsors may have access to an earlier entry route through Early PRIME, if compelling non-clinical data provide early evidence of promising efficacy. When available, efficacy clinical data will be needed to convert from Early PRIME to “full” PRIME scheme.
A PRIME eligibility request is submitted through the EMA portal IRIS, using a specific template. The information to provide consist of:
- Background information on the disease
- Background information on the product
- Existing treatments and unmet medical need
- Claim of major public health interest, including nonclinical and clinical data
- Next steps of development
About 2 months after submission, applicants receive the evaluation outcome, following the adoption/rejection by the Committee for Medicinal Products for Human Use (CHMP). Positive outcomes are made public, with the list of all products granted access to the PRIME scheme being updated monthly.
Once a medicine enters PRIME, a scientific coordinator will be appointed to support and guide the regulatory interaction.
Kick-off meeting: An early meeting is scheduled about 3 months after PRIME access is granted, to help align expectations, discuss development plans, and identify key evidence questions.
Following interactions: The process includes expert discussions and regulatory exchanges intended to strengthen the development pathway.
PRIME to date (May 2026)
How Boyds can help
At Boyds, our consultants bring extensive experience across a wide range of therapeutic areas and all stages of development, with particular expertise in advanced and novel therapies.
We can offer strategic advice about the suitability and timing of the PRIME scheme application. We can contribute to the creation of the application document, and manage communications with the EMA. We can provide support for the kick-off meeting and the following scientific advice meetings, helping to identify the key questions to discuss with the Agency, and to generate the applicant’s position in the briefing documents. Our support will help you to decisively address the challenges faced during product development and maximize the output received during advice meetings.
Céline Courtay-Cahen
Senior Manager, Regulatory Affairs
Meet the author
Dr Céline Courtay-Cahen is a highly knowledgeable regulatory affairs professional with over 10 years’ experience as a Regulatory Consultant, co-ordinating and managing projects on behalf of clients. With a PhD in Pharmacology specializing in cancer genomics. She provides operational support and strategic advice ranging from orphan drug designations to marketing applications, including early development support (PRIME in EU; Fast Track and Breakthrough in the US), clinical trials, and scientific advice. She has particular expertise in advanced therapy medicinal products (ATMPs) and biologics in both the US and Europe, and a special interest in live biotherapeutic products.