Brazil · Brazilian Health Regulatory Agency · New drugs
Review target
60 days
regulation
Legal time limit
-
Not published
Steps
8
6 requirements
Application fee
-
A fixed sequence for new medicines for rare diseases: a pre-submission meeting within 60 days of request, filing within 30 days of the meeting, a first review within 60 days, 30 days for the company to answer and 45 days for the final check. Phase II data with phase III ongoing can be accepted, and data can follow under a commitment term. New medicines (active ingredient new in Brazil for that rare disease) that treat, diagnose or prevent a rare disease affecting up to 65 people per 100,000, used in a serious debilitating condition and meant to change its course significantly.
The official review target is 60 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Pre-submission meeting request; 2. Pre-submission meeting (60 days); 3. File registration (30 days); 4. Rare disease status confirmed (45 days); 5. First review (60 days); 6. Company answers requirements (30 days); 7. Review of the answer (45 days); 8. Decision.
Outcome: Registration of the new medicine; GMP certification decided within 120 days. Valid for 10 years.
Legal basis: Anvisa RDC 205/2017
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 270 days end to end with the official step targets, of which up to 30 days are clock stops (time the applicant uses to answer). 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
| Review targetregulation. First review target after filing. Company answer time is not counted. | 60 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), Priority review of a registration petition, 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.