EMA PRIME (priority medicines) scheme

Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.

What PRIME is

PRIME enhances EMA's support for medicines that target unmet medical needs. It is based on early dialogue with companies to optimise development plans and speed up evaluation, building on existing tools such as scientific advice and accelerated assessment. Developers of a PRIME medicine can expect to be eligible for accelerated assessment when they apply for authorisation.^[1]

Which medicines qualify

PRIME focuses on medicines under development that are not yet authorised in the EU and target conditions with an unmet need, where no treatment exists or the medicine offers a major therapeutic advantage. Applicants must show available data with a meaningful improvement in clinical outcomes, such as an effect on the prevention, onset or duration of a condition, or on morbidity or mortality.^[1]

PRIME is not meant for products already in advanced development, in the pre-submission phase, or already authorised in the EU and seeking a new indication.^[1]

What developers receive

• A dedicated EMA contact point coordinating PRIME support.^[1]
• A kick-off meeting with the rapporteur and a multidisciplinary group of experts.^[1]
• Guidance on the overall development plan and regulatory strategy, and iterative scientific advice on key issues.^[1]

What PRIME means for patients and families

News that a medicine is in PRIME means regulators think it is promising and are helping its development. It does not mean the medicine can be prescribed or imported.

Before EU authorisation, access in Europe is through clinical trials or national compassionate use programmes. For patients in the Gulf, if the same medicine is approved by the US FDA, it can be requested through the local named-patient or special access route.^{[2, 3]}

How PRIME compares with US programs

The closest US equivalents are Fast Track and Breakthrough Therapy. Fast Track brings more frequent FDA meetings and possible rolling review; Breakthrough Therapy adds intensive guidance from Phase 1 when early evidence suggests substantial improvement over available therapy.^{[4, 5]}

None of these programs makes a medicine available before approval. Access before approval is through trials or, in the US, expanded access, which needs the manufacturer's agreement and FDA authorization.^[6]

Questions to ask the treating specialist

• Is this medicine still in development, or already authorised somewhere?
• Is there a trial with a site we could reach?
• If it is approved in the US first, could the hospital request it for the named patient here?

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.

We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.

Sources for these answers: ^{[1, 2]}

Related

• FDA Breakthrough Therapy designation
• EU compassionate use (Article 83)
• All access pathways
• US expanded access (compassionate use)
• Named-patient access, explained
• Answers to common access questions

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.