Brazil · Brazilian Health Regulatory Agency · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
4
3 requirements
Application fee
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Anvisa may grant registration with open items when public health benefits outweigh the risks. Items that are not low risk need a signed commitment term. Such registrations start with 3 years of validity, then 5 years after the first renewal and 10 after the second. New biologics for serious or high mortality diseases may be filed with phase II done and phase III ongoing. Medicines where some technical requirements will be completed after approval.
1. Registration petition; 2. Benefit-risk review; 3. Commitment term and decision; 4. Commitments fulfilled.
Outcome: Registration with conditions; can be suspended or cancelled if commitments are not met. Valid for 3 years.
Legal basis: Anvisa RDC 948/2024 (Art. 38); Anvisa RDC 912/2024 (Art. 3); Anvisa RDC 55/2010 (Art. 23)
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
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), Priority review of a registration petition, Special procedure for new medicines for rare diseases, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.