Brazil · Brazilian Health Regulatory Agency · Cell and gene therapy
Review target
-
Not published
Legal time limit
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Not published
Steps
4
3 requirements
Application fee
-
As an exception, Anvisa can register an advanced therapy product before full efficacy data exist. The company signs a commitment term with a clinical study schedule and reports every year. The agency has 120 days to decide. Serious debilitating or rare debilitating diseases, life threatening situations or public health emergencies, when no comparable alternative exists and the benefit of immediate access outweighs the missing data.
1. File the request; 2. Review (120 days); 3. Commitment term signed; 4. Annual compliance report (60 days).
Outcome: Registration valid for 5 years under a commitment term, monitored every year. Valid for 5 years.
Legal basis: Anvisa RDC 505/2021 (Chapter VI)
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 180 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
| Decisionregulation. Official maximum time for the agency decision. It is a target in the rules, not an observed review time. Time the applicant spends answering questions is not counted. | 120 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Brazil: Registration of an advanced therapy product, Advanced therapy for an individual patient without registration. See all routes on the Brazil 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.