On November 6, the Superior Court of Justice (STJ) approved a new timeline submitted by the Federal Government and established an additional 145 days for the publication of the regulatory act governing the cultivation of hemp for medical and pharmacological purposes. As a result, the regulation must be finalized by March 31, 2026.

This regulatory act is essential to comply with the STJ’s 2024 decision requiring clear rules for medical-purpose cultivation. The measure is expected to benefit more than 670,000 patients in Brazil who currently rely on Cannabis-based products – many of which are obtained through judicial authorizations.

With the deadline now set, ANVISA is expected to initiate a structured public participation process, including the preparation of technical documents, engagement with stakeholders, and subsequent submission of the draft regulation to the Board of Directors. Once approved, regulatory stages for sanitary monitoring and control will follow.

Our team remains available to monitor every step of this process, participate in the dialogues to be promoted by ANVISA, and support our clients in the interpretation, analysis, and implementation of the forthcoming regulatory framework.