The National Health Surveillance Agency (Anvisa) approved, on January 28, 2026, resolutions allowing cannabis cultivation for health treatments and research, along with new administration routes and plant imports. This step marks progress in the national production chain, easing access to plant-derived medicines. The changes broaden options for patients with severe illnesses while upholding strict restrictions.
On January 28, 2026, Anvisa's Board of Directors unanimously approved three resolutions regulating the cultivation, research, and production of cannabis by patient associations for pharmaceutical purposes. This decision updates RDC 327/2019 and marks a regulatory milestone in Brazil, where cultivation of Cannabis sativa—including hemp and marijuana—has been banned since Decree-Law No. 891 of 1938.
The new rules allow cultivation in controlled locations with THC levels below 0.3%, exclusively for medicinal and research use, including criteria like georeferenced coordinates and diversion prevention plans. Previously, pharmaceutical cultivation was prohibited, forcing imports of extracts and raising costs. In 2024, the Superior Court of Justice (STJ) authorized hemp planting for industrial and medicinal purposes, mandating Anvisa regulation.
Other changes include new administration routes—buccal, sublingual, and dermatological, in addition to prior oral and inhalation methods—and permission for compounding pharmacies to prepare pure cannabidiol phytopharmaceuticals. Plant imports are now allowed for national manufacturing, potentially lowering prices. Products exceeding 0.2% THC can be accessed by patients with severe debilitating diseases, not just terminal ones.
"It's an important milestone," says Bruno Pegoraro, president of the Ficus Institute, highlighting progress in the production chain. Physician Guilherme Nery from the Cannabis in Practice Institute praises the democratization and personalization of treatments. As of December 2025, there were 33 cannabidiol products and 16 cannabis extracts authorized in the country.
Despite the advances, the 0.3% THC limit is criticized as restrictive; Pegoraro advocates raising it to 1% for severe pain cases. Bill 299/2015, approved by a committee in 2021, remains stalled in Congress, underscoring legislative delays harming patients and the productive sector.
