This year marks 50 years since Law No. 6,360/1976 was enacted, the law that first established health surveillance requirements for medicinal products in Brazil.

Published in September 1976, Law No. 6,360 created the legal framework requiring medicinal products, drugs, active pharmaceutical ingredients, devices, cosmetics, and sanitizing products to undergo health surveillance before reaching the Brazilian market. It introduced the requirement of prior marketing authorization, along with quality control and traceability principles that remain foundational to Brazil’s regulatory system today.

The law predates ANVISA itself by 23 years. When the Agency was created in 1999 through Law No. 9,782, it inherited and began administering the framework that Law No. 6,360 had already put in place. Since then, the law has been amended repeatedly, most recently through Law No. 15,440/2026, to keep pace with the evolution of the health and pharmaceutical sector.

Half a century later, Law No. 6,360 remains the legal backbone for medicinal product marketing authorization in Brazil, the reference point from which decades of resolutions, normative instructions, and regulatory guides have since been built.