01/28/2026 | Ministry of Health

https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-aprova-por-unanimidade-regras-que-cumprem-decisao-do-stj-para-producao-de-cannabis-medicinal 

Regulations cover all stages of production for exclusively pharmaceutical purposes and establish monitoring and safety protocols.

The Brazilian National Health Surveillance Agency (Anvisa) approved this Wednesday (January 28, 2026), during the 1st Public Meeting of the Collegiate Board (Dicol) of 2026, the regulation of all stages of cannabis production for medicinal purposes in Brazil. The measure fulfills a ruling by the Superior Court of Justice (STJ) from November 2024, which defined the legality of production "for exclusively medicinal and/or pharmaceutical purposes linked to the protection of the right to health."

"This is a step that brings concrete hope to thousands of Brazilian families: by providing predictability and security for research and medicinal purposes, we pave the way for science and the country's productive sector to develop quality solutions for children, adolescents, adults, and the elderly, putting care first and bringing innovation closer to those who need it most," stated the director-president of Anvisa, Leandro Safatle.

Three Collegiate Board Resolutions (RDC) were presented to address issues of access to products and scientific research initiatives that, according to Leandro Safatle, fulfill the role of the Health Surveillance Agency in "providing responsible regulatory responses, based on evidence, so that the patient is at the center of decisions." The regulation is exclusively for medicinal purposes and considers all established sanitary rules.

Production

The first RDC (Regulatory Resolution) provides for the issuance of a Special Authorization (AE) for production exclusively by legal entities, with prior sanitary inspection and the requirement of traceability, control, and security mechanisms.

Production must be restricted to a THC content of up to 0.3%, a non-psychotropic substance, as established by the STJ (Superior Court of Justice). Only materials demonstrably within this standard may be imported or acquired. All inputs must be previously regulated by MAPA (registered cultivars), and all batches of the produced material must be submitted to laboratory analysis.

There is a provision that activities may be immediately suspended and production destroyed in cases of unjustified standards or any other possible irregularity. The measures meet the international control requirements of the UN Conventions and the International Narcotics Control Board (INCB).

The resolution also includes the permanent control and security of the premises. The creation of a committee coordinated by Anvisa (Brazilian Health Regulatory Agency), the Ministry of Justice, the Ministry of Health (MS), and the Ministry of Agriculture and Livestock (Mapa) is also planned to promote oversight and safety at all stages of production, with permanent control actions.

Research

The Research RDC (Regulatory Resolution) provides for the granting of Special Authorization exclusively to teaching and research institutions recognized by the Ministry of Education (MEC), public Scientific, Technological and Innovation Institutions (ICTs), pharmaceutical industries, and State Defense Agencies.

Safety and control requirements are also foreseen and involve prior inspection of the site by the health authority, the requirement of physical protection barriers and 24-hour surveillance – with a camera and alarm system, restricted access, and entry and exit control.

The products resulting from the research may not be commercialized, but may be shared with other institutions, duly authorized by Anvisa, for the performance of analyses and other activities inherent to the research. Products for research with THC above 0.3% must be obtained through importation with prior authorization from Anvisa (Brazilian Health Regulatory Agency) and compliance with the requirements established by the UN.

Associations

The third approved Resolution creates a specific instrument for non-profit patient associations, which also does not provide authorization for commercialization. The objective is to evaluate, in a controlled and supervised environment, the sanitary viability of small-scale production and operation, outside the industrial model; and to produce data and evidence on the quality and safety of production by these institutions for future regulatory decisions by Anvisa.

Anvisa will issue a public call for proposals with a maximum number of projects selected for each cycle, according to technical and sanitary criteria, production limits, and the number of patients served.

Like the other resolutions, this proposal also includes a monitoring plan with the definition of indicators and quality control requirements, as well as traceability of inputs and products until dispensing to patients.

Data-Driven Development

The development of the proposals, reported by director Thiago Campos, was supported by scientific research and other governmental institutions. Twenty-nine consultations were held with patient associations and the scientific community, in addition to an analysis of international experiences. The Agency received 47 scientific papers from 139 researchers, 41 of whom were from Brazil. Discussions also involved the Ministries of Health, Agriculture and Livestock, Justice, and the Brazilian Agricultural Research Corporation (Embrapa).

According to the rapporteur, the approved regulations establish a regulatory environment that covers the entire pharmaceutical production chain. “It starts from the premise that regulated, safe, and monitored cultivation, prohibiting any unauthorized use or use disconnected from the formal sanitary chain, enables the production of the raw material; the raw material, in more advanced stages, enables the production of medicines; and research provides the necessary substrate to determine, with greater precision, the real therapeutic potential of the plant,” he noted.

Update on Regulatory Standards

At the same meeting, the Agency approved an update to the regulatory framework for the manufacture and import of cannabis products for medicinal use in the country, RDC 327/2019.

Currently, 49 cannabis products are regulated by Anvisa and can be available in pharmacies and drugstores. These products, which are currently on the market, must advance to the stages of clinical studies that indicate a basis for efficacy for future approval as a medicine.

Among the innovations of the resolution is the expansion of the public that can make medicinal use of cannabis-based products, including patients suffering from serious debilitating diseases.

Another novelty is the possibility of new routes of pharmaceutical administration. Until now, only nasal and oral routes were foreseen. Based on already known scientific evidence, the regulation now authorizes dermatological, sublingual, buccal, and inhalational use, which broaden adherence to treatment for patients in special conditions.

Finally, the dissemination of information about cannabis-based medications by laboratories is restricted to prescribing professionals, and the information must be previously approved by Anvisa (Brazilian Health Regulatory Agency).

Compounding

This specific topic will be the subject of a new resolution, which will still be discussed by Anvisa.