New regulatory framework structures the production chain and opens space for domestic production
In a decision issued in Incident of Assumption of Jurisdiction 16, the 1st Section of the Superior Court of Justice recognized that the Federal Government and Anvisa had fulfilled their obligation to regulate the cultivation of cannabis for medicinal and pharmaceutical purposes.
The decision consolidates a relevant advance in the sector and validates the new regulatory framework established by the Collegiate Board Resolutions published in February 2026.
Among the main changes are the removal of Cannabis sativa with a THC content of up to 0.3 percent from the list of prohibited substances, the regulation of cultivation for medicinal and pharmaceutical purposes, the creation of an experimental regulatory environment, and the authorization to use domestic inputs in the manufacture of products.
The move continues the thesis established by the STJ itself in 2024, which had already allowed cultivation by legal entities for exclusively medicinal and pharmaceutical purposes.
WHAT CHANGES IN PRACTICE
The sector will now operate under a more structured regulatory regime, with clear rules covering the entire production chain.
The regulation details stages such as seed acquisition, cultivation, quality control, transportation, and traceability, raising the level of technical and sanitary requirements.
The possibility of using domestic inputs represents a relevant change, reducing dependence on imports and opening space for the development of a local production chain.
The creation of the regulatory sandbox indicates that the sector is still in a consolidation phase, allowing controlled testing and the evolution of rules based on practical data.
RISKS AND IMPLICATIONS FOR COMPANIES
Companies that were operating based on judicial decisions will need to fully adapt to the new rules.
The experimental regulatory environment may generate changes over time, requiring constant adaptability.
The control of THC content, limited to 0.3 percent, requires robust quality and monitoring systems.
The intensification of sanitary supervision increases the need for technical and regulatory governance.
At the same time, the new scenario increases competition and raises the entry standard for the sector.
STRATEGIC RECOMMENDATIONS
Interested companies should conduct a detailed analysis of the new RDCs to understand operational requirements and market opportunities.
The structuring of operations must consider everything from licensing to traceability and quality control processes.
The opening to domestic inputs creates new possibilities for vertical integration and cost reduction.
Evaluating participation in the regulatory sandbox may be strategic for companies seeking early positioning in the sector.
Continuous monitoring of regulatory developments is essential to ensure compliance and competitiveness.
INSTITUTIONAL REFLECTION
The validation of the regulation by the STJ marks the transition of the medicinal cannabis sector to a more structured and institutionalized model.
The topic is no longer predominantly judicial and becomes regulatory and business-oriented.
Companies that are able to align strategy, compliance, and operations will have a competitive advantage in an expanding market.
PDK Advogados monitors the evolution of the regulatory environment in highly regulated sectors and analyzes its impacts on business structuring, governance, and legal certainty. Through our institutional channels, we share content on regulatory trends and strategic opportunities.
