Brazil · Brazilian Health Regulatory Agency · New drugs
Review target
-
Not published
Legal time limit
120 days
law
Steps
6
7 requirements
Application fee
-
Registration petitions that meet public health criteria get a legal maximum of 120 days instead of 365. The agency checks eligibility within 45 days. Medicines registered with priority must reach the market within 365 days or the registration is cancelled. Neglected, emerging or serious debilitating diseases without alternatives, pediatric products without alternatives, vaccines for the national immunization program, products fully made in Brazil, the first new generic or biosimilar from a different economic group, public partnership products, or on formal request of the Minister of Health.
1. Priority requested; 2. Eligibility check (45 days); 3. Priority technical review (120 days); 4. Technical requirements (clock stopped) (60 days); 5. Decision; 6. Market launch within 365 days (365 days).
Outcome: Faster decision on the registration; all linked petitions, including GMP certification, are also prioritized.
Legal basis: Lei 6.360/1976 (Art. 17-A); Anvisa RDC 1.001/2025
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 530 days end to end with the official step targets, of which up to 60 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Validationregulation. Time for the agency to confirm the priority classification. | 45 days |
| Legal time limitlaw. 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 a new medicine, Registration of an innovative medicine, Registration of a generic medicine, Registration of a similar medicine, Non-prescription status (MIP) for a registered medicine, Registration of a new biological product (individual development route), Biosimilar registration (comparability route), Special procedure for new medicines for rare diseases, Registration under a commitment term, Optimized analysis using an equivalent foreign authority, Good manufacturing practice certification (CBPF). 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet