Brazil: ANVISA once again requests an extension of the deadline to regulate cannabis cultivation

Editor's note: Pedro Sabaciauskis' statements regarding meetings with associations were included on 10/13 at 14:43 pm.

During the 16th Public Meeting of the Board of Directors, the Brazilian National Health Security Agency (ANVISA) once again requested an extension to comply with the Superior Court of Justice's decision, which authorized the cultivation of cannabis for medicinal and pharmaceutical purposes. The Court had already demanded regulation of the cultivation last year, but ANVISA requested a postponement until September of this year. However, once again, ANVISA failed to comply, claiming it was impossible to create a regulatory framework for the industry in such a short timeframe, and requested a further extension. The THC limit is one of the most sensitive points of this regulation.

On October 8, 2025, the Brazilian Health Regulatory Agency (Anvisa) presented a technical update on the progress of regulating cannabis cultivation for exclusively medicinal and pharmaceutical purposes, as required by a court ruling. This presentation took place during the 16th Ordinary Public Meeting of the Board of Directors, broadcast live on Anvisa's YouTube channel, and provided new information on compliance with the Superior Court of Justice (STJ) ruling, which recognized the right to import seeds, plant, cultivate, and commercialize industrial hemp—as long as it is intended for therapeutic or pharmaceutical purposes.

A court decision that drives the debate
Rapporteur Director Thiago Campos highlighted that Anvisa is working together with the Attorney General's Office (AGU) and other federal agencies to consolidate a regulatory proposal that is "technically, safe and legally stable."

In November 2024, the Superior Court of Justice (STJ) ruled that industrial hemp, a variety of the plant with a THC content of less than 0,3%, cannot be considered prohibited, and that it is lawful to grant health authorizations to legal entities for cultivation and processing, limited to medicinal and pharmaceutical uses. To ensure a solid standard, the AGU (Authority of the Attorney General) requested an extension from the court, which will allow for a broader evaluation that also involves the Ministry of Agriculture and Livestock (MAPA) and the Ministry of Health. "The proposal must address scientific, health, production, and legal aspects in an integrated manner. The goal is for the regulation to not create obstacles to research, development, and innovation," Campos stated during the session.

The main areas of discussion include:

• Compliance with the STJ court decision;

• Rules for scientific research with cannabis in Brazil;

• The impacts of regulation on judicial decisions already issued and on the growing judicialization in the sector;

• Deadlines for regulatory and operational compliance;

• Maximum percentage of THC allowed in cannabis varieties grown under the new regulations;

Campos emphasized that the THC limit is one of the most sensitive points and will require technical balance: "We need to prevent a regulatory THC cap from hindering research and medications already authorized by Anvisa with higher levels. The debate should be based on scientific evidence, not moral perceptions," he stated.

ANVISA consults associations that started the movement and Embrapa 

The President of the Santacatarinense Association “Santa Cannabis”, Pedro Sabaciauskis,signed in reaction to the STJ decision, in November 2024 that "there was this recognition" of national production, which was "a movement initiated by associations." In his view, it only makes sense to create regulations that "consider associations and do not prioritize companies."

As part of the participatory development process, Anvisa announced two recent meetings. The first was with the Brazilian Agricultural Research Corporation (Embrapa), focusing on the role of agronomic research in the technological development of cannabis cultivation in Brazil. The second meeting, held in September, brought together patient and family associations to discuss the demand for therapies, access to products, and the judicialization of the process. Contacted by CannaReporter, the President of the Santa Cannabis Association stated that the discussion with the associations was "very positive," adding that, within their participation, the regulator committed to "dialogue with them and develop regulations that are science-based, transparent, and collaborative with society." These discussions, according to rapporteur Thiago Campos, will be fundamental to formulating the regulation: "We are listening to science and civil society. The goal is to develop regulations that guarantee access, quality, and safety without criminalizing patients or hindering research."

In the coming weeks, Anvisa's Board of Directors will consolidate the technical and legal contributions received before submitting the draft regulations for public consultation.

The process also provides for the definition of mechanisms for control, traceability and inspection of cultivation, in order to guarantee the restricted and safe use of cannabis.

With the advancement of the debate, Brazil takes an important step toward creating its own regulatory framework for the cultivation of medicinal cannabis, which could reduce dependence on imports and stimulate scientific and industrial production in Brazil. "Regulating cultivation is a natural and necessary step to guarantee the right to health and the advancement of research in the country," concluded Thiago Campos.

See the full ANVISA session here:

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Antonio João Costa

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I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.

I can be contacted by email at joao.costa@cannareporter.eu

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