Spain, through the European Union route · European Medicines Agency · Cell and gene therapy
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
8
12 requirements
Application fee
€865,200
From 2025-01-01
Gene therapies, somatic cell therapies and tissue engineered products must use the centralised procedure. The Committee for Advanced Therapies prepares the draft opinion, and the committee for human medicines adopts the final opinion. The European Commission decides. All advanced therapy medicinal products placed on the EU market. Custom-made products prepared on a non-routine basis for one patient in a hospital fall under a national exemption instead.
The official review target is 210 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The centralised marketing authorisation application where a new active substance is claimed (same fee rule as other medicines) is €865,200 for From 2025-01-01.
1. Pre-submission and eligibility; 2. Initial assessment with the advanced therapies committee (120 days); 3. First clock stop: applicant answers; 4. Further assessment and list of outstanding issues (60 days); 5. Second clock stop (if needed); 6. Draft opinion by the advanced therapies committee, final opinion by the committee for human medicines (30 days); 7. Re-examination (optional); 8. Commission decision (67 days).
Outcome: One marketing authorisation valid in every EU country, decided by the European Commission. Valid for 5 years.
Legal basis: Regulation (EC) No 1394/2007; Regulation (EC) No 726/2004, Annex I, point 1a
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 458 days end to end with the official step targets, of which up to 121 days are clock stops (time the applicant uses to answer). Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionofficial guidance. Time for the Commission decision after the agency recommendation, as stated by the agency. | 67 days |
| Review targetregulation. Maximum active days for the committee opinion. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 210 days |
| Typical total timeofficial guidance. The agency says the assessment of a new medicine usually lasts around a year, including clock stops. This is a general statement, not a target. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Centralised marketing authorisation application where a new active substance is claimed (same fee rule as other medicines)Application · From 2025-01-01 · SMEs: payment deferred until the decision. Designated orphan medicines: 10% reduction, or 100% for SMEs. | €865,200 |
Other routes in Spain: Centralised marketing authorisation, new active substance, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), Orphan designation, Paediatric investigation plan. See all routes on the Spain page or explore them in the Regulatory section.
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 (31 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.