Anvisa proposes creation of “Regulatory Sandbox” for cannabis cultivation by associations

The National Health Surveillance Agency (Anvisa) will hold this Wednesday (28), in Brasília, the 1st Public Meeting of the Collegiate Board of Directors (Dicol) of 2026. One of the highlights of the agenda is the voting on resolutions regarding medicinal cannabis, including the creation of a Regulatory Sandbox for associations.

The draft of the Collegiate Board Resolution (RDC) establishes an "Experimental Regulatory Environment" specifically focused on non-profit associative production. The measure aims to comply with the Superior Court of Justice (STJ) decision from November 2024, which recognized the legality of cultivation for medicinal purposes.

According to Daniel de los Santos, representative of Acuracan Therapeutic Association, the inclusion of entities in the Regulatory Sandbox is a victory for national mobilization. "Being included in the proposal is already tangible proof of Anvisa's recognition of the important role of Third Sector organizations," he states.

He mentioned that the sector's fear was being excluded from the discussion. "Our biggest fear was not being heard and being, once again, left out of the legislation," Santos concludes.

The Regulatory Sandbox model

The resolution draft proposes an exceptional and temporary regime, aimed at the controlled testing of activities related to Cannabis sativa L.. The objective of the Regulatory Sandbox is to allow associations to cultivate and produce inputs under the direct supervision of the Agency.

According to the text, this model does not authorize commercial, industrial, or advertising activities. The focus is on generating evidence and data on quality and safety to support a definitive regulatory decision in the future.

Production within the Regulatory Sandbox must occur, obligatorily, on a "small scale". The text emphasizes that activities must be carried out "outside the industrial model".

"The creation of a Regulatory Sandbox contemplates the innovation and complexity of associativism. It provides immediate legal certainty while the Agency learns how to regulate these institutions, creating rules consistent with reality," comments lawyer Emilio Figueiredo.

Fran Assis, from the Collective Historical Repair Association, believes that the model opens up to popular contribution. "It is undeniable that we, who work with real patients, know in practice that it is possible to produce derivatives of Cannabis sativa safely and accessibly, without interrupting care," he points out.

Criteria for participation in the Regulatory Sandbox

Participation in the experimental environment will not be automatic. Entities interested in joining the Regulatory Sandbox must undergo a selection process through a public call.

To apply, the legal entity must have been regularly established in the country for at least two years. The draft establishes rigorous operational limits for the functioning of approved associations.

The supply of products will be restricted to the medicinal and personal use of duly registered members. In addition, standardized production in series, typical of the conventional pharmaceutical industry, is prohibited.

Quality and safety requirements

Although the Regulatory Sandbox is an experimental model, the proposal requires compliance with sanitary requirements. Selected associations must meet the following demands:

- Appoint a legally qualified Technical Responsible;

- Present evidence of quality operational procedures;

- Control the origin of the plant material;

- Analyze the cannabinoid profile (THC and CBD content) in the products.

The text also stipulates that products must contain an explicit warning. The notice should state that the item "is not a medicine and has not been approved by Anvisa".

Project deadlines and monitoring

The maximum duration of the project in the experimental environment will be five years. Termination may occur early if unmitigated health risks are identified or if the rules of the Regulatory Sandbox are violated.

Participation in the program does not grant acquired rights or expectations of definitive authorization. According to Fran Assis, the moment calls for strategic analysis.

"We must analyze the political-administrative scenario to identify the institutional limits and the possible means to achieve our goal fairly and equitably," assesses Assis.

Daniel de los Santos reinforces his colleague's view on the need for comprehensive regulation. "We seek inclusive regulation that strengthens the Health Economic-Industrial Complex and ensures national sovereignty in the production of inputs, placing the right to health at the center of development," he concludes.

Context of the Anvisa vote

In addition to the regulation for associations via the Regulatory Sandbox, Dicol will discuss two other RDCs. One is focused on authorizing research centers, and the other on production for commercial purposes.

The development of the proposals involved an extensive analysis of data. Forty-seven scientific studies and 29 consultations with sector entities were considered, in addition to the participation of the Ministries of Health, Agriculture, Justice, and Embrapa.