Challenges for the new regulatory framework of medical Cannabis in Brazil

Until recently, the regulation of medical Cannabis (MC) in Brazil was based on norms that did not comprehensively address its sanitary and regulatory dimensions. In February 2026, the Brazilian Health Regulatory Agency (Anvisa) issued a new set of regulations - Collegiate Board Resolutions (RDCs) 1,011, 1,012, 1,013, 1,014, and 1,015 - covering MC from the update of the List of Controlled Substances to cultivation, research, production, quality control, and regulatory experimentation (regulatory sandbox). These regulations are expected to represent a significant shift in the regulatory framework, with potential implications for research and evidence generation, its use within the Brazilian Unified Health System (SUS), and litigation for access. However, important challenges remain, including regulatory clarity regarding controlled substances, the need for coordination among governmental bodies - including Anvisa - in implementing the new framework, difficulties faced by producers in adapting to the new requirements, and, notably, the persistent regulatory gap concerning imports. Positive outcomes will depend on strengthening the research agenda and on producing robust evidence to support health technology incorporation and public financing.