The entry into force of Anvisa's Collegiate Board Resolutions (RDCs) numbers 1,011 to 1,015 of 2026 represents a watershed moment in the regulation of medicinal cannabis.

This set of regulations consolidates the guidelines established by the Superior Court of Justice (STJ) in the judgment of the Incident of Assumption of Competence (IAC) number 16, enhancing legal certainty for research, cultivation, and industrialization in the country.

Below, we present a detailed analysis of the practical operation of the new rules and their effects on the Brazilian pharmaceutical market.

The STJ ruling and the transition to the administrative sphere

In November 2024, the First Section of the STJ recognized the lawfulness of cultivating industrial hemp exclusively for medicinal and pharmaceutical industrial purposes.

The ruling ordered Anvisa to issue detailed regulations on the sector. The result of this process was the publication of the package of RDCs in the first half of 2026.

Subsequently, the STJ itself confirmed that the regulations issued complied with the ruling in an adequate and comprehensive manner, extending the special regulatory treatment to products with a tetrahydrocannabinol (THC) content of up to 0.3%.

The new regulatory design of Anvisa's RDCs

The five new Anvisa resolutions organize the sector through a functional and operational division of activities:

• RDC 1.011/2026: It promoted an amendment to Ordinance 344/1998 to remove the species Cannabis sativa L., with a THC content of up to 0.3%, from the list of prohibited plants (List E) and include it in the list of controlled substances (Schedule C1).
• RDC 1,012/2026: Regulates cultivation rules for scientific and research purposes, allowing the acquisition of domestic seeds from authorized suppliers, without exclusive dependence on importation.
• RDC 1.013/2026: It establishes cultivation parameters for the pharmaceutical and therapeutic use of plants containing up to 0.3% of THC, covering traceability, monitoring, and the safe transport of raw materials.
• RDC 1,014/2026: It established the Regulatory Sandbox, which allows for monitored testing of cultivation and processing focused on innovation under the direct supervision of the regulatory agency.
• RDC 1,015/2026: It revoked the former RDC 327/2019, regulating the process of industrialization, distribution, and trade of medicinal Cannabis products.

Urgent compliance deadlines for companies

For establishments currently operating based on preliminary or final judicial decisions, Anvisa has imposed specific transition deadlines.

Companies in this condition must adapt their operations and obtain the respective Special Authorization (AE) by the date of August 5, 2027.

Failure to comply with this deadline will result in the loss of legal protection for the cultivation and handling of the substances, requiring prompt and preventive action by regulatory departments.

Regulatory sandbox and risk governance

The Experimental Regulatory Environment (Sandbox) created by RDC 1.014/2026 will have a maximum duration of five years.

Because of its transitional and testing nature, participation in the program does not guarantee acquired rights or the automatic obtaining of definitive authorization after the expiration of the term.

Therefore, companies that decide to participate must carefully structure the allocation of regulatory risks in their contracts with investors and partner suppliers.

Industrialization, new formats, and tariff flexibility

RDC Resolution 1,015/2026 brought important benefits by eliminating the mandatory import of pharmaceutical inputs, thereby stimulating domestic verticalized production.

There was also an expansion of the permitted routes of administration, with the inclusion of buccal, sublingual, and dermatological forms of use.

Another relevant point clarified by Anvisa is that, because they are in a transitional category, these products are not under the price control of CMED (Chamber of Regulation of the Medicine Market) until they undergo final drug registration.

Medical Cannabis in Brazil: Crucial Regulatory Aspects