France · National Agency for the Safety of Medicines and Health Products · Cell and gene therapy
Review target
90 days
official guidance
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
-
Marketed advanced therapy medicines go through the EU centralised procedure. Advanced therapies prepared on a non-routine basis are instead covered by an ANSM authorisation of the preparing establishment. The ANSM reviews the file within 90 days, often with an inspection, and asks the biomedicine agency for an opinion. The authorisation lasts five years. An establishment that prepares, stores, distributes or supplies advanced therapy medicines on a non-routine basis, including investigational ones.
The official review target is 90 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Send the application; 2. Technical review (90 days); 3. Opinion of the biomedicine agency; 4. Decision.
Outcome: An authorisation of the establishment's activities, valid for five years and renewable. Valid for 5 years.
Legal basis: Code de la santé publique, Article L.4211-9-1 and Articles R.4211-32 and following; Regulation (EC) No 1394/2007
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 90 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 targetofficial guidance. Time to review the file. This is an official target, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: Early access authorisation, Compassionate access authorisation (named patient), Pharmaceutical establishment authorisation (operator, manufacturer, importer, distributor). See all routes on the France 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.