Executive summary
Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) regulates peptides as medicines, compounding ingredients, or cosmetics. The 2025–2026 period saw a significant regulatory wave restricting compounding of GLP-1 peptides, introducing new quality requirements, and intensifying enforcement.
Authorities and legal categories
ANVISA: drug registration, GMP inspection, compounding oversight, import control, post-market surveillance.
Câmara Técnica de Medicamentos (CTMED): advisory committee for medicine classification.
Key instruments:
Lei 6.360/1976 and Lei 9.782/1999 (ANVISA creation).
RDC (Resolução da Diretoria Colegiada) series.
NT 200/2025 — biotecnológico vs. synthetic API rules.
RDC 973/2025 — prescription retention and SNGPC reporting for GLP-1 class.
Despacho 97/2025 — compulsory quality testing for manipulated peptides.
Draft IN (Instrução Normativa) April 2026 — CADIFA/CEP requirements, peptide mapping mandate.
- Identify the intended product or activity.
- Check registered medicine, lawful compounding, import, research material, or consumer-promotion rules against current ANVISA records.
- Research-use-only bulk has no automatic bridge to a patient product.
Approved medicines
Approved peptide medicines include Expansion of the abbreviation used in the monographs: glucagon-like peptide-1 receptor agonist. The atlas does not define the pharmacology of this class; see the monograph for what is documented about a specific compound. Источник определения: Neutral gloss; the abbreviation is printed on the tirzepatide monograph but the atlas does not define the class pharmacology · Глоссарий (semaglutida/Ozempic, Wegovy; liraglutida/Victoza, Saxenda; tirzepatida/Mounjaro), insulin analogues, teriparatida (Forteo), leuprorrelina, octreotida, desmopressina, and calcitonina.
Source: ANVISA medicines register, https://www.gov.br/anvisa
Compounding/manufacturing
Brazil has a well-developed compounding sector (farmácias de manipulação). RDC 67/2007 historically governed compounding; RDC 973/2025 and NT 200/2025 introduced new restrictions:
NT 200/2025: distinguishes biotecnológico peptides (produced via rDNA) from synthetic peptides for API classification. Only synthetic peptides can be compounded from bulk.
RDC 973/2025: requires prescription retention and notification to SNGPC for all GLP-1 class compounded preparations.
Despacho 97/2025: mandates minimum quality testing and canal amarelo (adverse event) reporting.
Compounding of semaglutida from bulk "research" raw materials is banned under the 2025 regulatory wave. Only approved API sources are permitted.
Draft IN (April 2026): would require CADIFA (Active Pharmaceutical Ingredient Specific Certificate) or CEP for peptide APIs, and mandate peptide mapping for identity.
Import
Commercial medicine import generally requires ANVISA registration, subject to statutory personal-use, clinical and other exceptions. Products outside an applicable pathway may be refused or seized.
ANVISA reported that more than 100 kg of the relevant material was imported in the second half of 2025. Separately, its 2026 announcement reported 11 inspections, eight interdictions, and ten prohibitory actions. The authority did not characterize the 100 kg figure as a 2026 port seizure.
Research-use-only products
Brazil has no research-use-only exemption. Products meeting the drug definition require ANVISA registration.
Enforcement examples and uncertainty
| Date | ANVISA instrument/action | Activity covered | Operative status | Source |
|---|---|---|---|---|
| 2025 | NT 200/2025 | Classification of biotechnology-derived and synthetic peptide APIs for compounding | Technical note described as operative on this page | ANVISA |
| 2025 | RDC 973/2025 | Prescription retention and SNGPC reporting for GLP-1-class compounded preparations | Rule described as operative on this page | ANVISA |
| 2025 | Despacho 97/2025 | Minimum quality testing and adverse-event reporting | Operative dispatch described on this page | Diário Oficial source |
| Second half of 2025 | Authority-reported import figure | More than 100 kg of the relevant material imported | Dated statistic; not characterized by ANVISA as a 2026 port seizure | ANVISA |
| April 2026 | Draft Instrução Normativa | Proposed CADIFA or CEP requirements and peptide-identity mapping | Draft proposal, not presented as a final operative rule | ANVISA |
| 2026 | Authority enforcement announcement | 11 inspections, eight interdictions, and ten prohibitory actions | Dated authority report; not a measure of the entire market | ANVISA |
What the cited 2025–2026 actions do not prove
The cited rules, proposal, statistics, and enforcement examples do not establish the status of every peptide or quantify the whole Brazilian market. Product, ingredient, activity, instrument date, and operative status still require separate verification.
Practical interpretation limits
This is general regulatory research, not legal advice. Classification can turn on composition, claims, intended use, route, supplier role, and facts not captured by a product name.
Related atlas pages: Latin America overview, cross-border supply, global framework, and approved-product label index.
Primary sources
ANVISA. https://www.gov.br/anvisa
RDC 973/2025 and NT 200/2025 (searchable via ANVISA regulatory agenda).
Despacho 97/2025. https://www.in.gov.br (search "Despacho 97/2025").
Lei 6.360/1976. https://www.planalto.gov.br/ccivil_03/LEIS/L6360.htm