Challenges for the new regulatory framework of medical Cannabis in Brazil

Abstract

Until recently, the regulation of medical Cannabis (MC) in Brazil was based on norms that did not comprehensively address its sanitary and regulatory dimensions. In February 2026, the Brazilian Health Regulatory Agency (Anvisa) issued a new set of regulations - Collegiate Board Resolutions (RDCs) 1,011, 1,012, 1,013, 1,014, and 1,015 - covering MC from the update of the List of Controlled Substances to cultivation, research, production, quality control, and regulatory experimentation (regulatory sandbox). These regulations are expected to represent a significant shift in the regulatory framework, with potential implications for research and evidence generation, its use within the Brazilian Unified Health System (SUS), and litigation for access. However, important challenges remain, including regulatory clarity regarding controlled substances, the need for coordination among governmental bodies - including Anvisa - in implementing the new framework, difficulties faced by producers in adapting to the new requirements, and, notably, the persistent regulatory gap concerning imports. Positive outcomes will depend on strengthening the research agenda and on producing robust evidence to support health technology incorporation and public financing.

Key words:
Medical Cannabis; Health regulation; Public health policy

Resumo

Até recentemente, a regulação da Cannabis medicinal (CM) no Brasil se baseava em normas que eram insuficientes para abordar integralmente os aspectos sanitários da CM. Em fevereiro de 2026, a Anvisa publicou um conjunto de normas, as resoluções da Diretoria Colegiada (RDCs) 1011, 1012, 1013, 1014 e 1015, que abordam a CM, desde a atualização da Lista de Substância Sujeitas a Controle Especial, passando pelo cultivo, pesquisa, produção, controle de qualidade e experimentação regulatória (ambiente regulatório especial - sandbox regulatório). Estima-se que essas normas tenham trazido uma mudança bastante significativa para a regulação, com consequências potenciais sobre a pesquisa e geração de evidências para sua utilização no âmbito do SUS e para a judicialização do acesso. No entanto, persistem desafios, como a falta de clareza na regulação quanto ao controle especial, a necessidade de integração entre instâncias governamentais - inclusive a Anvisa - na implementação das normas, as dificuldades dos produtores de CM para se adequarem a essas exigências e, sobretudo, a persistente lacuna na regulação das importações. Os desdobramentos positivos dependerão do fortalecimento da agenda de pesquisa e da produção de evidências para subsidiar a incorporação tecnológica e o financiamento público.

Palavras-chave:
Cannabis medicinal; Regulação sanitária; Políticas públicas de saúde

Resumen

Hasta hace poco, la regulación del Cannabis medicinal (CM) en Brasil se basaba en normas que resultaban insuficientes para abordar de manera integral sus aspectos sanitarios. En febrero de 2026, la Agencia Nacional de Vigilancia Sanitaria (Anvisa) publicó un conjunto de normas - las Resoluciones de la Dirección Colegiada (RDC) 1.011, 1.012, 1.013, 1.014 y 1.015 - que regulan la CM desde la actualización de la lista de sustancias sujetas a control especial hasta el cultivo, la investigación, la producción, el control de calidad y la experimentación regulatoria (entorno regulatorio experimental o sandbox regulatorio). Se estima que estas normas han introducido un cambio significativo en el marco regulatorio, con posibles consecuencias para la investigación y la generación de evidencia, su utilización en el Sistema Único de Salud (SUS) y la judicialización del acceso. No obstante, persisten desafíos relevantes, como la claridad regulatoria en lo que respecta al control especial, la necesidad de articulación entre instancias gubernamentales - incluida la Anvisa - para la implementación de las normas, las dificultades de los productores para adaptarse a ellas y, especialmente, la persistente laguna en la regulación de las importaciones. Los efectos positivos dependerán del fortalecimiento de la agenda de investigación y de la producción de evidencia que sustente la incorporación tecnológica y el financiamiento público.

Palabras-clave:
Cannabis medicinal; Regulación en salud; Políticas públicas de salud

Introduction

Until 2025, the regulation of medical Cannabis (MC) in Brazil was primarily based on two regulations: (a) RDC 327/2019, which created the category of “Cannabis product” for domestic production and commercialization¹; and (b) RDC 660/2022, which governs exceptional importation by individuals, upon prescription and with sanitary authorization from the Brazilian Health Regulatory Agency (Anvisa)². However, these regulations were insufficient to comprehensively address the various aspects of MC sanitary regulation, leaving gaps and inconsistencies in the regulatory framework.

In February 2026, Anvisa issued a new set of regulations - Collegiate Board Resolutions (RDCs) 1011, 1012, 1013, 1014, and 1015^3-7. Resulting from extensive public debates held over recent years, these resolutions represent the most comprehensive proposal ever presented for the regulation of MC in the country. The new framework seeks to establish a controlled production chain for medical Cannabis, encompassing cultivation, research, production, quality control, traceability, and governance, as well as providing for a regulatory transition period and the creation of an experimental environment aimed at evaluating regulatory arrangements.

What changes with the new regulations

The new RDCs were introduced to address evident regulatory gaps considering the expansion of the medical Cannabis market in Brazil⁸. In this context, (i) RDC 1,011 updates the lists of Ordinance 344/1998, creating exceptions for Cannabis and its derivatives and clarifying concepts related to the plant and its therapeutically active compounds³; (ii) RDC 1,012 regulates cultivation for research purposes⁴; (iii) RDC 1,013 establishes criteria for cultivation for medicinal and pharmaceutical purposes⁵; (iv) RDC 1,014 creates an experimental regulatory environment (regulatory sandbox) to test non-industrial production arrangements - including patient associations⁶; and (v) RDC 1,015 updates and consolidates concepts and requirements for the production and commercialization of Cannabis products, revoking RDC 327/2019⁷. This regulatory package should be interpreted alongside the special control regime (Ordinance SVS/MS No. 344/1998), which remains central in guiding prescription, control, and sanitary oversight in the country⁹.

A key change is the introduction of explicit sanitary guidelines for cultivation. Until then, RDC 327/2019 neither authorized nor regulated this activity, creating room for litigation and fragmented authorizations¹. The new framework provides for cultivation in three contexts: scientific research, through authorization granted to legal entities (RDC 1012/2026); production for medicinal purposes, through special authorization (SA) (RDC 1013/2026); and regulatory experimentation (RDC 1014/2026).

The new framework also aligns regulatory concepts, reaffirming that Cannabis products are not automatically classified as herbal medicines⁷. Although RDC 327/2019 created the category “Cannabis product,” ambiguities remained regarding distinctions between herbal drugs, herbal medicines, and botanical pharmaceutical inputs, which the new regulations seek to reduce.

Regarding THC, there were no substantial changes in prescribing practices. The 0.2% threshold remains, but the clinical criterion has been redefined. Previously linked to patients in “palliative care,” it now refers to individuals with “severe, life-threatening debilitating diseases”⁷. This change refers primarily to terminology, but it may influence patterns of use. The proper definition of palliative care encompasses its application in debilitating and irreversible conditions and is not limited to end-of-life situations; rather, it includes severe, disabling, or potentially fatal conditions that significantly impair quality of life¹⁰. Thus, whereas the lay perception of “palliative care” as care provided only in terminal phases may previously have shaped both care and the intensity of MC use, its use in other clinical situations is now justified and may supersede this interpretation.

RDCs 1012 and 1013 also establish regulatory differentiation for cultivation based on THC content. Varieties with THC levels above 0.3% are authorized only for research purposes, while cultivation for pharmaceutical purposes must use varieties below this threshold^4,5. Varieties presenting total THC levels above 0.3% (weight/weight) in dried inflorescences must be destroyed.

An Experimental Regulatory Environment (Regulatory Sandbox) is introduced by RDC 1014 to test non-industrial production arrangements on a pilot basis - particularly involving patient associations. These entities, which previously existed in a de facto legal grey area, are now granted special authorization for production. Thus, Brazil appears to adopt a gradual, cautious, and technically oriented regulatory model.

Other countries have also adopted regulatory experimentation models. France, one of the main European Cannabis markets, implemented a controlled experimental model for patients with severe conditions¹¹, initiated in 2021. It includes a regulated access pathway during the experimental phase, with temporary use authorization issued by the regulatory agency (ANSM). At the end of the experiment, the assessed therapeutic value will guide decisions on continued availability.

Finally, RDC 1,015/2026 reinforces labeling rules and restricts the use of terms such as full spectrum, broad spectrum, “oil,” or “full extract,” among other imprecise terminologies. It also establishes a five-year period (renewable for an equal period) for authorized products to generate sufficient clinical evidence to apply for registration as medicines; otherwise, authorization may be revoked⁷.

Potential impacts on research

Cannabis research remains an open agenda. The plant contains hundreds of phytocannabinoids and exhibits substantial chemical variability across cultivars, cultivation methods, extraction processes, and the final composition of extracts. This heterogeneity makes it difficult to conduct clinical trials capable of establishing clear causal relationships between products and therapeutic effects¹².

In Brazil, there is already a specific regulatory framework for herbal medicines¹³, with differentiated criteria for registration. Notably, medical Cannabis has not yet reached this regulatory stage and remains classified as a “product,” precisely because it has not completed the full clinical development pathway required for medicines.

Developing a medicine involves very high costs, which creates expectations of substantial profits for the pharmaceutical industry. If profits are already ensured through current sales, what would be the incentives to conduct a costly clinical trial, the outcome of which may be uncertain? This issue has been highlighted in the literature¹⁴.

The new regulations suggest an effort by Anvisa to steer the sector toward greater standardization and control, guiding these products into a more structured model and creating regulatory conditions for research and development. Nevertheless, progress will depend on how stakeholders respond to these requirements and on how future research is conducted.

Consequences for the Brazilian Unified Health System (SUS)

In general, regulatory advances tend to produce positive effects by facilitating access to safe and effective products - provided that such safety and efficacy are demonstrated. At present, however, the new regulations have no direct impact on the Brazilian Unified Health System (SUS). Medical Cannabis does not yet meet the requirements for routine use in the SUS.

It is important to distinguish between products and medicines. Cannabis products have not undergone the full clinical development and regulatory approval process required for medicines.

From a therapeutic perspective, medical Cannabis is not considered a first-line option. Clinical protocols typically follow stepwise treatment approaches, with MC appearing, at most, as an alternative in refractory cases, such as certain pediatric epilepsies¹⁵.

Medical Cannabis has also not been incorporated into the SUS by the National Commission for the Incorporation of Technologies in the Brazilian Unified Health System (Conitec)¹⁶. Its incorporation would depend on health technology assessment and inclusion in the National Essential Medicines List, which has not yet occurred due to insufficient robust evidence. These products also remain costly, particularly when imported, and even domestic production still involves significant prices. This creates a sensitive combination: lack of technological incorporation, limited clinical evidence, and high costs.

Although patients have the right to choose therapies prescribed by their physicians, when therapeutic decisions involve the public system, it is necessary to consider the distributive impact of such choices, since allocating resources to one area may reduce investments in others¹⁷. Under shared financing rules, a substantial portion of these costs tends to fall on subnational entities, particularly for treatments below certain financial thresholds, as established by decisions of the Brazilian Supreme Federal Court (STF)¹⁸, thereby burdening state and municipal budgets.

In this regard, the new regulations may contribute to guiding research and production. If robust evidence of safety and efficacy is generated and medicines are marketed at affordable prices, it will be possible to speak of positive outcomes for the SUS.

Litigation for access to MC

Litigation for medical Cannabis (MC) is predominantly characterized by demands for cultivation authorization and lawsuits seeking access to products. Since cultivation was prohibited, there was a surge in legal actions - particularly habeas corpus petitions - filed by individuals seeking authorization for personal use and by organizations seeking permission for cultivation . With the new regulatory framework, legal entities that meet sanitary requirements may request authorization to cultivate and produce, which is expected to reduce part of these judicial demands and foster research and development. Nevertheless, judicialization is likely to persist, especially in cases involving individual cultivation by private persons and in claims for the provision of products.

Health litigation arises precisely from the tension between a broad rights framework and an immature regulatory system. Moreover, it is not neutral from a distributive standpoint: it assumes access to the Judiciary and the ability to mobilize resources. For this reason, it tends to favor those with greater capacity to access the system, while potentially diverting resources that would otherwise be allocated to the regular provision of public policies. Currently, a significant share of high-cost demands occurs through the courts¹⁹.

Challenges

A central issue concerns the regulation of Cannabis sativa L. under Ordinance SVS/MS No. 344/1998, which remains ambiguous even after the changes introduced by RDC 1,011/2026. Cannabis sativa L. continues to be listed as a prohibited plant under List E, while its cultivation is simultaneously authorized under specific and regulated conditions. This situation is unique: no other plant listed under List E has similar exceptions. Even species that give rise to substances with medicinal purposes, such as Papaver somniferum L. (the plant from which morphine is derived), remain prohibited for cultivation. Of the 15 amendments to Ordinance 344/1998, nine address Cannabis and its derivatives, introducing successive exceptions related to content thresholds and exclusions. These changes ultimately increase regulatory complexity. In this regard, it would be desirable for Anvisa to advance in reorganizing this framework by removing Cannabis from List E and creating a specific and provisional regulatory category within the Ordinance itself, in alignment with the differentiated regulatory status already established by the Agency.

The regulation of Cannabis also requires greater coordination among different governmental bodies. Cultivation extends beyond Anvisa’s direct competence and requires coordination with other administrative authorities.

Another relevant challenge concerns Anvisa’s own technical and institutional capacity. The new regulations significantly expand the Agency’s regulatory scope, including monitoring cultivation, implementing the regulatory sandbox, ensuring quality control, conducting laboratory analyses, and maintaining traceability. These requirements imply an adequate institutional structure to oversee and monitor regulated activities. This will require expanding technical capacity, increasing team specialization, and developing clear monitoring protocols.

There are also uncertainties inherent to the regulatory sandbox model itself. Although it represents a relevant innovation, its outcomes will depend on how social, commercial, and clinical pressures are managed.

A major unresolved challenge is the regulation of imports. Currently, any patient with a prescription may import MC products through automatic authorization on Anvisa’s website. There is no provision for post-marketing surveillance to protect users. If domestic rules become excessively restrictive for national products, without equivalent control over imported ones, the risk of circulation of products lacking proven efficacy, safety, or quality will persist. This also weakens the domestic production chain, which is still in the early stages of development in Brazil, while favoring large pharmaceutical industries in dominating the market.

Finally, the production sector will also face significant challenges in adapting to the new framework. During the period of sanitary authorization, it will be necessary to develop technical-scientific monographs, implement systems for control and quality assurance of the finished product - which must be presented as a specific and standardized product - and conduct the studies required for products to apply for registration as medicines. This implies substantial investment in research and development, laboratory infrastructure, and clinical trials. These requirements that may prove difficult for some companies to meet.

Conclusion

Anvisa’s role is to protect public health and, therefore, its regulatory action must also encompass productive activities. Strong regulation in the health sector is essential to ensure the safety and quality of products that will be consumed by the population.

Although the new regulatory framework strengthens the “product-manufacture” dimension, it still needs to address key challenges, such as the regulation of imports and the strengthening of the research agenda to generate evidence and guide decisions on incorporating health technology and public financing.

It is important to recognize that the new framework will only produce effective gains for the Brazilian Unified Health System (SUS) if regulation is accompanied by an explicit agenda for generating evidence; a public policy aligned with health technology assessment and financing; and monitoring mechanisms for access, including individual importation, capable of reducing asymmetries and litigation.

The establishment of an integrated, safe, and equitable medical Cannabis policy will depend on products achieving medicine status with proven efficacy, effectiveness, and safety. Only then can they may meet the criterion of essentiality and be incorporated into public policy.

Acknowledgments

The authors thank Fiocruz and the Ministério da Saúde.

References

• ¹ Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC no 327, de 9 de dezembro de 2019. Dispõe sobre os procedimentos para a concessão da Autorização Sanitária para a fabricação e a importação, bem como estabelece requisitos para a comercialização, prescrição, a dispensação, o monitoramento e a fiscalização de produtos de Cannabis para fins medicinais, e dá outras providências. Diário Oficial da União 2019; 11 dez.
• ² Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC no 660, de 30 de março de 2022. Define os critérios e os procedimentos para a importação de produto derivado de Cannabis, por pessoa física, para uso próprio, mediante prescrição de profissional legalmente habilitado, para tratamento de saúde. Diário Oficial da União 2022; 31 mar.
• ³ Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC no 1011, de 30 de janeiro de 2026. Dispõe sobre a atualização do Anexo I (Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outra Controle Especial) da Portaria SVS/MS no 344, de 12 de maio 1998. Diário Oficial da União 2026; 3 fev.
• ⁴ Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC no 1012, de 30 de janeiro de 2026. Dispõe sobre os requisitos para o cultivo da espécie vegetal Cannabis sativa L. destinado exclusivamente a fins de pesquisa. Diário Oficial da União 2026; 3 fev.
• ⁵ Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC no 1013, de 30 de janeiro de 2026. Dispõe sobre os requisitos para o cultivo da espécie vegetal Cannabis sativa L. com teor de THC menor ou igual a 0,3% destinado exclusivamente a fins medicinais e/ou farmacêuticos. Diário Oficial da União 2026; 3 fev.
• ⁶ Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC no 1014, de 30 de janeiro de 2026. Institui Ambiente Regulatório Experimental (Sandbox Regulatório) para testagem controlada de atividades relacionadas à Cannabis para fins medicinais. Diário Oficial da União 2026; 3 fev.
• ⁷ Agência Nacional de Vigilância Sanitária. Resolução RDC no 1015, de 2 de fevereiro de 2026. Dispõe sobre a Autorização Sanitária para fabricação e importação de produtos de Cannabis para uso medicinal humano e estabelece requisitos relativos à sua comercialização, e dá outras providências. Diário Oficial da União 2026; 3 fev.
• ⁸ Pinto CDBS, Esher Â, Oliveira CVS, Osorio-de-Castro CGS. A expansão do mercado da Cannabis medicinal no Brasil e os desafios da regulação. Cad Saude Publica 2024; 40(11):e00088624.
• ⁹ Brasil. Ministério da Saúde. Portaria SVS/MS nº 344, de 12 de maio de 1998. Aprova o regulamento técnico sobre substâncias e medicamentos sujeitos a controle especial. Diário Oficial da União 1998; 15 maio.
• ¹⁰ Brasil. Portaria GM/MS nº 3.681, de 7 de maio de 2024. Institui a Política Nacional de Cuidados Paliativos - PNCP no âmbito do Sistema Único de Saúde - SUS, por meio da alteração da Portaria de Consolidação GM/MS nº 2, de 28 de setembro de 2017. Diário Oficial da União 2024; 22 maio.
• ¹¹ Direction de l'information légale et administrative (France). A new step towards access to medical Cannabis [Internet]. 2025 [acessado 2026 mar 12]. Disponível em: https://www.service-public.gouv.fr/particuliers/actualites/A16479?lang=en
  » https://www.service-public.gouv.fr/particuliers/actualites/A16479?lang=en
• ¹² Koltai H, Poulin P, Namdar D. Promoting Cannabis products to pharmaceutical drugs. Eur J Pharm Sci 2019; 132:118-120.
• ¹³ Brasil. Agência Nacional de Vigilância Sanitária (Anvisa). Resolução nº 1.004, de 17 de dezembro de 2025. Dispõe sobre o registro de medicamentos fitoterápicos e o registro e a notificação de medicamentos tradicionais fitoterápicos. Diário Oficial da União 2025; 22 dez.
• ¹⁴ Caputi TL. The Medical Marijuana Industry and the Use of "research as marketing". Am J Public Health 2020; 110(2):174-175.
• ¹⁵ Rodrigues DS, Soares ASB, Bueno CDF. The use of cannabinoids in children with epilepsy: a systematic review. Epilepsy Behav 2023; 145:109330.
• ¹⁶ Nishida L, Cavedini RC. Disputando as evidências, negando a pertinência: o processo para incorporação dos derivados de Cannabis no SUS. Mediacoes 2023; 28(3):e48571.
• ¹⁷ Krauss-da-Silva L, Osorio-de-Castro CGS. Custo de oportunidade, limiar de custo-efetividade, deslocamento tecnológico e perda líquida de saúde no processo de incorporação e difusão de tecnologias em sistemas nacionais de saúde [Internet]. 2026 [acessado 2026 mar 12]. Disponível em: https://preprints.scielo.org/index.php/scielo/preprint/view/15088
  » https://preprints.scielo.org/index.php/scielo/preprint/view/15088
• ¹⁸ Supremo Tribunal Federal (STF). Tema 1234 - legitimidade passiva da União e competência da Justiça Federal nas demandas que versem sobre fornecimento de medicamentos registrados na Agência Nacional de Vigilância Sanitária (ANVISA), mas não padronizados no Sistema Único de Saúde (SUS) [Internet]. 2024 [acessado 2026 mar 12]. Disponível em: https://portal.stf.jus.br/jurisprudenciaRepercussao/tema.asp?num=1234
  » https://portal.stf.jus.br/jurisprudenciaRepercussao/tema.asp?num=1234
• ¹⁹ Pepe VLE, Baptista MR, Ventura M, Hora MFVMP, Alvarez NR, Pinto GS, Silva RS, Vidal TJ. Acesso judicial a medicamentos para doenças raras: características das ações movidas contra a União. Cien Saude Colet 2026; 31(1):e14312025.

• Funding
  Fiotec - Ministério da Saúde/Fiocruz - Análise de demandas judiciais em saúde contra a União para tratamentos à base de Canabidiol - TED 1.2022.
• Data availability statement
  The data sources adopted in the research are indicated in the article’s body.

• Chief editors:
  Maria Cecília de Souza Minayo, Romeu Gomes, Antônio Augusto Moura da Silva, Vania de Matos Fonseca

Data availability

The data sources adopted in the research are indicated in the article’s body.

Publication Dates

• Publication in this collection
  29 June 2026
• Date of issue
  May 2026

History

• Received
  17 Feb 2026
• Accepted
  19 Mar 2026
• Published
  21 Mar 2026