1st Ordinary Public Meeting in 2026 of the Board of Directors of the National Health Surveillance Agency (Anvisa) in Brazil discusses the regulation of medicinal cannabis production
Three Resolutions from the Board of Directors were presented to address issues of access to products and scientific research initiatives which, according to the President of Anvisa (Brazilian Health Regulatory Agency), fulfill the role of the Health Surveillance Agency in "providing responsible, evidence-based regulatory responses so that the patient is at the center of decisions.". The regulation is exclusively for medicinal purposes and considers all established sanitary rules. The President of Anvisa states that this is a step that brings concrete hope to thousands of Brazilian families.
Brazil’s National Health Surveillance Agency (Anvisa) began the year by approving regulations for all stages of cannabis production for medicinal purposes in Brazil during the 1st Public Meeting of the Board of Directors. On this occasion, three resolutions from the Board of Directors were presented to address issues of access to products and scientific research initiatives.
The first Resolution provides for the issuance of a Special Authorization for production exclusively by legal entities, with prior sanitary inspection and requirements for traceability, control, and safety mechanisms.
Production must be restricted to a THC content of up to 0.3%, a non-psychotropic substance. Only materials demonstrably within this standard may be imported or acquired. All inputs must be previously regulated by the Ministry of Agriculture and Livestock (registered cultivars), and all batches of the produced material must be submitted to laboratory analysis.
The second Resolution on research provides for the granting of Special Authorization exclusively to educational and research institutions recognized by the Ministry of Education, public Scientific, Technological and Innovation Institutions, pharmaceutical industries, and State Defense Agencies.
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 and compliance with the requirements established by the UN.
The third Resolution approved creates a specific instrument for non-profit patient associations, which also does not provide for 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.
At the same meeting, the Agency approved the update to the regulatory framework for the manufacture and import of cannabis products for medicinal use in the country, Resolution 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 then, only nasal and oral routes were foreseen. Based on already known scientific evidence, the regulation now authorizes dermatological, sublingual, buccal, and inhalational use, which increase adherence to treatment for patients in special conditions.
The full report and video recording of the meeting can be accessed via the following link:
Rafaela Mattos
Patent Advisor. Lawyer.