Brazil · Brazilian Health Regulatory Agency · Cell and gene therapy
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
An advanced therapy made non-routinely for a specific patient in imminent life threat, with no alternative in Brazil, is not registered. Cell and tissue products need a prior notice to Anvisa; gene therapy needs prior authorization, which Anvisa answers within 30 days. These products cannot be sold. Individual patients in imminent risk of death with no therapeutic alternative available in Brazil, under a licensed professional. Not for expanded access or compassionate use programs.
1. Prior notice or authorization request; 2. Agency answer for gene therapy (30 days); 3. Follow-up report per patient (180 days).
Outcome: Use is allowed for the named patient. Sale is prohibited.
Legal basis: Anvisa RDC 505/2021 (Art. 13 and Chapter VII)
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 210 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. Applies to gene therapy authorization only. If the agency does not answer within 30 days, the product may be given. | 30 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Brazil: Registration of an advanced therapy product, Advanced therapy registration with additional efficacy data to follow. 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.