Brazil · Brazilian Health Regulatory Agency · New drugs
Review target
-
Not published
Legal time limit
365 days
law
Steps
6
10 requirements
Application fee
R$37,231
Fee table in force when checked (2026-10-03)
Registration for an improvement on a medicine already registered as new in Brazil, such as a new combination, new route, new strength, new dosage form, new pack or new indication. Evidence can come from clinical and nonclinical studies, comparative studies or published technical and scientific data. Line extensions and other changes that create a different product from an existing new medicine.
The registration fee for a new route, new strength, new dosage form, new combination or monodrug approved in combination is R$37,231 for Fee table in force when checked (2026-10-03). A reduced fee of R$3,723 applies in some cases (Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 1,861.55).
1. Optional pre-submission guidance; 2. File the registration petition; 3. Technical review (365 days); 4. Technical requirements (clock stopped); 5. Decision published; 6. Public assessment report.
Outcome: Registration published in the Official Gazette, valid for 10 years. Valid for 10 years.
Legal basis: Lei 6.360/1976; Anvisa RDC 948/2024; Anvisa RDC 753/2022
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 365 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
| 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. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Registration fee for a new route, new strength, new dosage form, new combination or monodrug approved in combinationApplication · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 1,861.55. | R$37,231reduced R$3,723 |
Other routes in Brazil: Registration of a new medicine, Registration of a generic medicine, Registration of a similar medicine, Non-prescription status (MIP) for a registered medicine, Priority review of a registration petition, 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), Registration of a class III or IV medical device. 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.