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Anvisa Updates Regulation of Medical Cannabis, Expands Medical Use, and Defines Rules for Cultivation, Research, and Products in Brazil.
The National Health Surveillance Agency (Anvisa) officially established a new milestone for medical cannabis in Brazil this week by defining rules for the cultivation, research, and commercialization of plant derivatives.
The measure was announced in Brasília after publication in the Official Gazette, and detailed by the chairman Leandro Pinheiro Safatle during an interview on the CB Poder program.
The decision expands medical use, strengthens cannabis regulation, and seeks to ensure safety, quality, and access for patients, as well as to stimulate scientific research and reduce costs in the sector.
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New Regulation of Cannabis Expands Treatment Options
With the new rules, Anvisa now allows the commercialization of cannabis-based medications for oral, sublingual, and dermatological use.
Previously, only oral and inhalation products could apply for registration for sale in the country.
This expansion represents a significant step for patients who rely on specific therapeutic alternatives.
Moreover, it strengthens the market for regulated cannabis products, with broader sanitary and pharmaceutical control.
The update meets a determination from the Superior Court of Justice (STJ), which ordered the creation of a clearer regulatory framework for the issue, reinforcing the legal security of the sector.
Regulatory Evolution Marks a Change in Stance by Anvisa
According to Leandro Pinheiro Safatle, the new set of regulations represents institutional maturation.
“We managed to achieve a significant regulatory evolution for the country. The rapporteur carried out important work to listen to society to bring together this cohesive set of rules. Until then, we predominantly had authorizations for the importation of cannabis derivatives,” he stated.
Since 2015, when medical cannabis regulation began in Brazil, more than 660,000 products have been requested by patients.
In 2019, the country progressed by allowing some domestic production, still limited to the final stages of the production process.
Currently, there are 49 cannabis-based products available in the Brazilian market, supplied by 24 companies. All undergo quality control and sanitary safety.
Anvisa Now Regulates the Entire Chain of Medical Cannabis
With the publication of the new rules, Anvisa expands its regulatory reach and begins to supervise the entire production chain.
This includes the cultivation of the plant, scientific research, the processing of raw materials, and the final medication.
“With the published rules, it is possible to carry out the entire cycle, from raw material to finished medication,” Safatle explained.
Additionally, the agency formally authorized research conducted by universities, public institutions, and private companies.
The goal, according to Anvisa’s president, is to ensure that cannabis products are increasingly based on robust scientific evidence.
Few Medications and Many Products in Transition
Despite the progress, Safatle acknowledges that there are still few registered medications based on cannabis.
The reason, he states, lies in the time required for complete clinical studies mandated by Anvisa.
“What we have are many derivative products being marketed. The regulation approved by Anvisa authorizes these products and allows time for research to provide evidence for them to evolve into medications,” he affirmed.
This model allows medical use to progress in a controlled manner without compromising patient safety.
Vacatio Legis and Control Against Recreational Use
The ordinance establishes a vacatio legis period of six months, allowing public agencies and companies to adapt to the new requirements.
Thus, after this period, interested parties may request formal authorizations from Anvisa.
One of the agency’s main concerns is to prevent diversion for recreational use.
Therefore, the production process will be rigorously controlled, with geolocation, monitoring, and THC limits.
“The focus is on medicinal and pharmaceutical service, including cannabis containing up to 0.3% THC,” Safatle emphasized.
Possible Access Through SUS and Price Reduction
Thus, in addition to Anvisa, the ministries of Agriculture, Finance, and Health are involved in the regulatory process.
According to Safatle, there is a future possibility of incorporating these medications into the Unified Health System (SUS).
After sanitary approval, products will also undergo price analysis and review by Conitec, responsible for evaluating the inclusion of new technologies in the public system.
Studies cited by Anvisa indicate that the new cannabis regulation could reduce prices by up to 60%, as well as decrease research costs.
An experimental environment, known as a regulatory sandbox, will allow small-scale testing for up to five years.
Thus, medical cannabis advances in Brazil as a health policy, scientific innovation, and economic development, under clearer rules and strict oversight.
See more at: ‘Evolution’, says Anvisa president about medical cannabis
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