Brazil ANVISA

Anvisa Creates Cosmetovigilance Technical Chamber, Portaria 471/2026

ANVISA has established a Technical Chamber of Cosmetovigilance (CTEC) under Portaria 471/2026, linked to the General Management for Monitoring Products Subject to Health Surveillance (GGMON). The chamber has a consultative nature and comprises five titular members and five alternates from higher education and research institutions across different regions of Brazil, plus representation from the Ministry of Health. The CTEC will analyze and evaluate safety signals, propose regulatory measures, develop methodologies and technical criteria, and qualify data from notification systems and other sources.

Final Results Published, Brazilian Pharmacopeia Selection, 2026-2031 Committees

ANVISA published the final results of the 2026 selection process for the Brazilian Pharmacopeia (Farmacopeia Brasileira), including appeal evaluation outcomes, overall scores, and results by committee. Selected candidates will compose the Technical Thematic Committees that will operate from 2026 to 2031. The Brazilian Pharmacopeia establishes minimum quality, authenticity, and purity requirements for pharmaceutical inputs, medicines, and other health-surveillance products.

ANVISA Discusses Normative Instruction for GLP-1 Pen Manipulation

ANVISA's Collegiate Board will discuss at its April 29 public meeting a proposed normative instruction establishing technical requirements for compounded GLP-1/GIP receptor agonist medications. The instruction covers import procedures, supplier qualification, quality control testing, stability, storage, and transport of active pharmaceutical ingredients for magistral manipulation. The draft is available for public consultation as part of a broader action plan announced April 6, 2026, addressing irregularities in weight-loss pen importation and manipulation.