The Brazilian Health Regulatory Agency (Anvisa) has published, in the Brazillian Official Gazette, a set of Collegiate Board Resolutions (RDCs) and administrative orders that consolidate significant advances in the regulation of activities related to Cannabis sativa L. in Brazil. These measures were adopted in compliance with a determination issued by the Superior Court of Justice (STJ) in REsp No. 2,024,250/PR (IAC 16) and form part of Anvisa’s 2026/2027 Regulatory Agenda.

The published rules establish a new sanitary regulatory framework for the control of substances, the cultivation of the plant for specific purposes, scientific research, and supervised regulatory testing, with effectiveness as of August 4, 2026.

Key highlights include:

• RDC No. 1,011/2026, which updates Annex I to Ordinance SVS/MS No. 344/1998, governing the lists of narcotics, psychotropic, precursors, and other substances subject to special control. The resolution introduces new addenda and adjusts rules on control, prescription, importation, and commercialization, including regulatory exceptions involving plants, fungi, and derivatives, with direct impact on cannabis-related products.
• RDC No. 1,012/2026, which establishes requirements for the cultivation of Cannabis sativa L. exclusively for research purposes, authorizing such activity only for legal entities previously accredited by Anvisa. The resolution sets stringent criteria for authorization, security, control, traceability, storage, disposal, transportation, and importation, and expressly prohibits commercialization of the cultivated material.
• RDC No. 1,013/2026, which regulates the cultivation of Cannabis sativa L. with a THC content equal to or lower than 0.3%, exclusively for medicinal and research purposes. The rule requires Special Authorization, establishes detailed requirements for control, traceability, laboratory testing, transportation, and supply, prohibits exportation of the material, and mandates the destruction of plants that exceed the THC threshold. It also sets a compliance deadline of August 5, 2027 for cultivation activities currently supported by court decisions.
• RDC No. 1,014/2026, which establishes a Regulatory Sandbox for the controlled and temporary testing of activities related to medicinal cannabis, including cultivation, production of plant raw material, and preparation of derivatives on a small scale and outside an industrial model. The experimental environment will be supervised by Anvisa, allows for limited regulatory flexibility, does not confer vested rights or definitive authorization, and aims to generate evidence to support future regulatory decisions.
• RDC No. 1,015/2026, which sets forth specific sanitary rules applicable to activities related to medicinal cannabis, complementing the new regulatory framework. The resolution reinforces technical criteria, sanitary controls, responsibilities of the parties involved, and traceability mechanisms, without authorizing broad industrial production or recreational use.

In turn, Administrative Orders No. 4 and No. 5/2026 approve the opening of Administrative Regulatory Proceedings, with waiver of Regulatory Impact Analysis (RIA) and Public Consultation, both to amend Ordinance No. 344/1998 and to establish the Regulatory Sandbox. These measures directly comply with the STJ’s determination and seek to structure, in a gradual and controlled manner, the regulation of cannabis cultivation with THC content ≤ 0.3% for medicinal, pharmaceutical, and research purposes.

Taken together, the measures published by Anvisa consolidate a specific regulatory framework for the cultivation, research, and sanitary control of Cannabis sativa L., with clearer technical criteria aligned with the jurisprudence of the Superior Court of Justice.

Accordingly, the new rules impose the need to obtain specific authorizations, implement robust traceability and security systems, and adapt internal procedures by research institutions, associations, and other potentially interested stakeholders. At the same time, the creation of regulated and experimental environments, such as the regulatory sandbox, tends to foster scientific and technological development in the sector, increasing legal predictability for research and innovation initiatives.

We remain available to assist with the interpretation of the new rules, the monitoring of regulatory developments, and the assessment of legal and operational impacts applicable to each specific case.