Brazil peptide regulation

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.

• 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.

Approved peptide medicines include GLP-1 receptor agonists (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

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.

• 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.

Brazil has no research-use-only exemption. Products meeting the drug definition require ANVISA registration.

• 2025–2026: ANVISA active enforcement against research peptide importers and compounders using unauthorised bulk substances.

• April 2026 draft IN signals further tightening of peptide API quality requirements.

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.

1. ANVISA. https://www.gov.br/anvisa

2. RDC 973/2025 and NT 200/2025 (searchable via ANVISA regulatory agenda).

3. Despacho 97/2025. https://www.in.gov.br (search "Despacho 97/2025").

4. Lei 6.360/1976. https://www.planalto.gov.br/ccivil_03/LEIS/L6360.htm