Spain, through the European Union route · European Medicines Agency · New drugs
Review target
150 days
regulation
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
-
For medicines of major public health interest, in particular therapeutic innovation, the committee for human medicines can shorten its review from 210 to 150 days. The applicant asks for it before submitting the application. Centralised applications for medicines of major interest for public health, for example those that address an unmet medical need.
The official review target is 150 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Request for accelerated assessment; 2. Committee decides on the request; 3. Accelerated assessment (150 days); 4. Commission decision (67 days).
Outcome: A shorter review clock. The decision on the request has no effect on the final opinion.
Legal basis: Regulation (EC) No 726/2004, Article 14(9)
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).
About 217 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Shortened time limit for the committee opinion. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 150 days |
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, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.