Cannabis cultivation and regulatory review take center stage in the 2026–2027 Regulatory Agenda

The National Health Surveillance Agency (Anvisa) approved the Anvisa Regulatory Agenda (RA) for the 2026-2027 biennium. The decision was made during the 20th Public Ordinary Meeting of the board, held on Wednesday (10).

The official document presents the topics considered a priority for regulation in the next two years. The final list consists of 161 items, with a focus on crucial updates in the controlled products sector.

Cannabis topics in Anvisa's Regulatory Agenda

Two topics related to cannabis for medicinal purposes were included on the agenda. Topic 1.11 specifically addresses the regulation of local cultivation of cannabis with a content of up to 0.3% tetrahydrocannabinol (THC).

The inclusion of this topic in Anvisa's Regulatory Agenda complies with the decision of the Superior Court of Justice (STJ) in Special Appeal No. 2024250/PR. According to the Agency, the objective is to enable safe access to essential products and services for the population's health.

Another relevant point is topic 9.16, which foresees the review of the regulation of cannabis products for medicinal purposes (RDC 327/2019). The amendment to the norm was recently discussed by the Collegiate Board, but the process was suspended after a request for review, with a 30-day deadline for return.

Distribution of subjects in the new Agenda

Among the 161 topics in Anvisa's Regulatory Agenda, 97 migrated from the 2024-2025 cycle. The document also includes 26 topics for periodic updates and 38 new subjects introduced in this cycle.

Of these new topics, 28 were suggested by the technical areas of the agency itself. Another 10 were incorporated based on suggestions received from the public during the consultation of the preliminary list.

The highest concentration of regulatory proposals is in the pharmaceutical (38 topics) and food (35 topics) sectors. Cross-cutting issues and medical devices also stand out, with 18 and 14 topics respectively.

Social Participation and Formalization

The elaboration process had broad popular participation and involvement of the National Health Surveillance System (SNVS) bodies. Between August and September, a public consultation on the preliminary list received 647 forms.

Anvisa's 2026-2027 Regulatory Agenda will be formalized through an ordinance in the Official Gazette of the Union. The validity of the new document officially begins on January 1, 2026.