In Brazil’s pharmaceutical landscape, the most critical regulation governing the lifecycle of medicinal products is Law No. 6,360/1976. Enforced by Anvisa (Agência Nacional de Vigilância Sanitária), this law, ANVISA´s Resolutions of the collegiate board, normative instructions and guidesestablishes the legal and operational framework for the sanitary control of medicines, drugs, pharmaceutical inputs, and related products across their entire lifecycle—from development and registration to commercialization and post-market surveillance.Regulating Medicines in Brazil: Why Law 6,360/1976 Still Sets the Standard?Enacted in 1976, Law No. 6,360 lays the foundation for Brazil’s health Regulatory system. It defines the requirements for manufacturing, importing, marketing, labeling, packaging, advertising, and registration of medicinal products and their subsequent renewal.This law ensures that all medicinal products distributed in the Brazilian market meet predefined safety, efficacy, and quality standards, and that these standards are consistently upheld throughout the product’s lifecycle.Scope and Regulatory CoverageThe law applies to a wide range of products, including:Medicines and drugs for human usePharmaceutical raw materials and inputsDiagnostic and therapeutic medical productsCosmetics, sanitizers, and personal hygiene items (where applicable)Medical Device and other health related products