Spain, through the European Union route · European Medicines Agency · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
6
2 requirements
Application fee
-
PRIME is a European Medicines Agency scheme that gives early and enhanced support to developers of medicines that target an unmet medical need. Support includes early appointment of a rapporteur, iterative scientific advice and a submission readiness meeting. Products in PRIME can expect to be eligible for accelerated assessment. Medicines in the exploratory clinical trial phase with preliminary clinical evidence of potential to address an unmet medical need to a significant extent. SMEs and academic applicants can ask for Early Entry with strong non-clinical data.
1. Eligibility request; 2. Eligibility granted; 3. Rapporteur appointed; 4. Kick-off meeting; 5. Submission readiness meeting; 6. Application with confirmation of accelerated assessment.
Outcome: PRIME eligibility. It gives enhanced support and an expected eligibility for accelerated assessment at the time of application.
Legal basis: Agency scheme built on scientific advice and accelerated assessment under Regulation (EC) No 726/2004
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: Centralised marketing authorisation, new active substance, Centralised authorisation of advanced therapy medicinal products, Centralised marketing authorisation, known active substance or new fixed combination, Centralised hybrid application, Centralised biosimilar application, Centralised well-established use application, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Paediatric investigation plan, Integral drug-device combination authorised as a medicine, Decentralised procedure. See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.