The recent evolution of Brazil’s regulatory framework—projected through 2026—has sparked a wave of analysis that often oscillates between social activism and corporate optimism. However, for those of us operating at the intersection of Administrative Law and high-complexity Life Sciences, the analysis demands a different kind of sobriety. Cannabis regulation in Latin America is not an exercise in rhetoric; it is a discipline of technical precision where success is measured not by “market openings,” but by the procurement and maintenance of sanitary registrations that guarantee patient safety. (1)
The normative foundation of this regulatory architecture is Resolution da Diretoria Colegiada n° 327/ANVISA, of 2019 (RDC 327/2019), which first established the procedures for granting Sanitary Authorization (Autorização Sanitária) for the manufacture and importation of cannabis-based products for medicinal purposes—setting forth comprehensive requirements governing the entire product lifecycle, from commercialization and medical prescription to dispensation, post-market monitoring, and regulatory oversight. It is upon this foundation that the 2026 regulatory cycle has built three new resolutions of critical importance.
Institutional Sophistication vs. The Narrative of Exception
Brazil has taken a fundamental step by formalizing domestic cultivation under the strict supervision of ANVISA. Nevertheless, there is a latent risk in interpretations that celebrate the “flexibility” of the new regulatory framework created in 2026. In the Civil Law jurisdictions that govern our region, flexibility is often merely the preamble to administrative discretion.
Establishing a 0.3% THC threshold for hemp, while confining therapeutic THC to “controlled environments” or regulatory sandboxes, poses a significant scalability challenge.
While experimental regulatory mechanisms are valuable for institutional learning, they must not become a permanent state of exception. The pharmaceutical industry requires legal certainty, not temporary permits. The transition from a pilot project to a permanent Marketing Authorization (Registro Sanitario) is the precise legal vacuum where foreign investment often dissipates, particularly when investors fail to grasp the rigidity of our sanitary surveillance systems.
Two of the 2026 resolutions directly address these structural concerns. Resolution n° 1013/ANVISA, of 2026 (RDC 1013/2026), gives concrete normative substance to the 0.3% THC threshold by establishing detailed requirements for the domestic cultivation of Cannabis sativa L. with THC content equal to or below 0.3%, exclusively for medicinal and pharmaceutical purposes—delineating the precise conditions under which hemp cultivation can operate within the sanitary surveillance perimeter. Meanwhile, Resolution n° 1015/ANVISA, of 2026 (RDC 1015/2026), updates and broadens the Sanitary Authorization regime for the manufacture and importation of cannabis products for human medicinal use, signaling ANVISA’s intent to transition from the initial posture of RDC 327/2019 toward a permanent and operable regulatory regime—the kind of maturation from pilot to permanent Marketing Authorization that is essential for investor confidence and legal certainty.
The Mexican Case Study: Foresight and the “Regulatory Bottleneck”
In observing the regional landscape, Mexico stands as a benchmark of regulatory sophistication, but also as a cautionary tale of operational timing. Back in July 2020, in an interview with Milenio, I warned that a regulation born from stigma and an “excess of controls and approval procedures” would inevitably cause entrepreneurs and foreign investors to “arrive late to the market.”
Six years later, that diagnosis has proven accurate. The Mexican model represents a “standard of excellence” that, while technically superior, demands a level of strategic investment that many found prohibitive. The lesson for Brazil is clear: technical sophistication—if not accompanied by agile administrative operability—can raise entry barriers to levels that only the most resilient capital actors can surmount. The challenge is not merely to “regulate,” but to ensure the regulation is operable within the economic reality of our region.
Traceability and the Missing Link of Intellectual Property
Current narratives often speak lightly of “seed-to-patient” traceability as a mere control concept. From a sanitary law perspective, traceability is far more: it is the guarantee of product stability and the bedrock of pharmacovigilance.
However, there is a gap that corporate narratives frequently overlook: the need for harmonization between the health authority (ANVISA) and the agricultural authority (MAPA). Without a clear registry of plant varieties and robust protection for Intellectual Property, traceability remains a surveillance system without a productive engine. In Latin America, the success of a cannabis operation does not depend on the “freedom to cultivate,” but on the ability to defend a patent or a plant breeder’s right within a supply chain that adheres strictly to Good Manufacturing Practices (GMP).
In this context, Resolution n° 1012/ANVISA, of 2026 (RDC 1012/2026), plays a complementary but vital role by establishing the requirements for the cultivation of Cannabis sativa L. exclusively for research purposes. By creating a distinct regulatory track that separates scientific investigation from commercial production, RDC 1012/2026 enables the generation of the technical and pharmacological data upon which traceability systems, patent claims, and variety registrations ultimately depend—ensuring that Brazil’s productive chain is anchored in evidence-based science. (2)
The “Masterful” Solution: The Compounding Pharmacy as the Third Way
The inclusion of patient associations within the Brazilian ecosystem is a commendable milestone for human rights. However, the legal challenge lies in the convergence of models. How do we integrate artisanal production with the rigorous quality standards that ANVISA demands of any other phytopharmaceutical?
The answer lies in a model I have advocated for throughout my career: the Masterful Pharmacy (Compounding Pharmacy).
In the current Latin American context, the industrial pharmaceutical path is often too slow and expensive for immediate patient needs, while the artisanal path lacks the necessary sanitary rigor. The Masterful Pharmacy model represents the perfect regulatory bridge. It allows for personalized medicine, adjusted to the specific needs of the patient under the strict supervision of a licensed pharmacist, ensuring standardized quality without the prohibitive costs of a mass-industrial launch. However, RDC 1015/2026 states that compounding of magistral preparations is permitted only when the active pharmaceutical ingredient is cannabidiol (CBD) derived exclusively from Cannabis sativa L., in accordance with regulations to be issued by ANVISA.
For Brazil to truly unlock its potential in 2026, it must look beyond the binary choice of “Industrial vs. Association” and embrace the Masterful Pharmacy as the primary vehicle for real access. This is the only model that solves the “compliance” gap while maintaining the sanitary excellence that agencies like ANVISA and COFEPRIS demand.
A Vision of State for the Global South
Brazil is well positioned to lead the Southern Cone, but it must avoid oversimplified narratives imported from jurisdictions with disparate legal traditions. Cannabis in Latin America requires its own vision, grounded in scientific rigor and regulatory diplomacy.
The future of cannabis in our region does not belong to the “pioneers” of marketing, but to the architects of regulation. It belongs to those who understand that a well-structured technical dossier and a robust compounding pharmacy network are the most powerful tools for democratizing access to healthcare. Less lyricism and more technicality: that is the path for cannabis to cease being a regulatory promise and become a sustainable therapeutic reality.
Together, the four ANVISA instruments—RDC 327/2019, RDC 1015/2026, RDC 1013/2026, and RDC 1012/2026—form an integrated normative system that, if administered with the agility and coherence advocated throughout this analysis, can position Brazil not merely as a regional leader, but as a global reference for science-based cannabis regulation in the Civil Law tradition.
- The author expresses her sincere gratitude to Elysangela Rabelo, partner of Life Sciences and Healthcare practice area at Demarest, for her expert review and invaluable technical contributions to the analysis of the Brazilian regulatory framework and the 2026 ANVISA resolutions presented in this article. Her insights ensure the highest level of normative precision regarding the evolution of sanitary surveillance in Brazil.
- Attorney Rabelo comprises the analysis of the Brazilian regulatory framework and the 2026 ANVISA resolutions presented in this article. Her insights ensure the highest level of normative precision regarding the evolution of sanitary surveillance in Brazil.
Founder, MLA Legal & Consulting | Founder, XTIGMA
A pioneering force in Latin American regulatory law, Mariana Larrea Arias combines over a decade of high-level legal expertise with entrepreneurial vision to shape the future of the cannabis, wellness, and life sciences industries in Mexico.
Mariana Larrea Arias is a distinguished regulatory attorney based in Mexico City, recognized as a leading authority in the nation’s evolving cannabis and hemp sectors. With more than ten years of experience at some of Mexico’s most influential law firms, she currently directs MLA Legal & Consulting. Through her firm, she advises a diverse portfolio of domestic and international clients—ranging from multinational corporations and institutional investors to pioneering innovators—on navigating the complex regulatory frameworks of Latin America. Currently, she is spearheading a Magistral Compounding project designed to accelerate the development of the medical cannabis market in Mexico.
