Medical Cannabis in 2026: The Evolution of a Finally Regulated Market

Brazil’s medical cannabis regulatory framework underwent a substantial reformulation in 2026. The set of rules published early in the year by the National Health Surveillance Agency (“Anvisa”) broadens the scope of the regulatory framework applicable to the sector and reorganizes the rules governing research, cultivation, manufacturing, importation, and commercialization of cannabis products.

The change comes amid a growing market. According to Kaya Mind’s new annual report, the Brazilian medical cannabis market closed 2025 with estimated revenue of R$ 970.9 million[1]. This growth has been accompanied by increasing litigation over access to treatment, market maturation, and the need to revise the regulatory model.

A key milestone was the ruling issued by the Superior Court of Justice (“STJ”) in 2024, which required Anvisa to regulate the cultivation, industrialization, and commercialization of industrial hemp for exclusively medicinal and pharmaceutical purposes, subject to a maximum limit of 0.3% tetrahydrocannabinol (“THC”) in the plant.

Following that ruling, the Agency published three complementary but distinct regulatory acts. RDC No. 1,012/2026 governs the cultivation of Cannabis sativa L. intended exclusively for scientific research. RDC No. 1,013/2026 sets out the requirements for plant production by authorized legal entities for medicinal and pharmaceutical purposes. RDC No. 1,015/2026[2] repeals RDC No. 327/2019 to govern the manufacturing, importation, and commercialization of cannabis products for human medicinal use.

Another significant element of this regulatory package was the creation of the Experimental Regulatory Environment (regulatory sandbox) through RDC No. 1,014/2026. According to Anvisa, the sandbox constitutes a controlled testing environment in which companies may test, for a limited period and under specific conditions, innovative cannabis products and services that face regulatory barriers and could not otherwise be tested under current rules.

Closer to Medicines, Without Full Regulatory Equivalence

Since the publication of RDC No. 327/2019, cannabis products have belonged to their own regulatory category, distinct from the category of medicines. The revision introduced by RDC No. 1,015/2026 preserves that regulatory choice. These products remain subject to an exceptional, transitional regime based on the granting of a Health Authorization (“AS”), rather than the sanitary registration or notification required for medicines — even though both are administrative acts intended to subject the product to the Agency’s scrutiny.

But the distinction is not merely terminological. In the registration of medicines, Anvisa evaluates the full set of data applicable to the relevant category, covering the elements needed to demonstrate quality, safety, and efficacy. In an AS request for a cannabis product, by contrast, proof of efficacy is not required, although the company must present the technical-scientific grounds related to the product’s development and control.

The AS is a regulatory mechanism created specifically to allow controlled access to products whose risk-benefit assessment still depends on the progressive development of scientific evidence. This regime should not be confused with a simplified form of registration, nor with the sanitary notification applicable to certain product categories. It is a distinct authorizing act, provided for specifically and exclusively for cannabis products.

At the same time, RDC No. 1,015/2026 expands the application of requirements traditionally associated with medicine regulation: Good Manufacturing Practices, quality control, analytical method validation, stability studies, pharmaceutical forms, and routes of administration will now apply to cannabis products — largely mirroring the rules applicable to specific medicines or herbal medicines, depending on the nature of the active ingredient used.

This convergence, however, does not eliminate important structural differences. Products authorized under RDC No. 1,015/2026 remain outside the prior-pricing regime of the Drug Market Regulation Chamber (“CMED”), precisely because they are not registered medicines. Likewise, unlike medicines, compounding of cannabis products remains prohibited under an express Anvisa decision, which deliberately excluded that possibility from the text of RDC No. 1,015/2026 and left the matter to future regulation. Until such a rule is issued, there is no authorization for compounding cannabis products.

Implementation of RDC No. 1,015/2026 and Industry Questions

In July 2026, Anvisa published a Questions and Answers document on Health Authorization for Cannabis Products[3], compiling the Agency’s understanding of how the new regulation applies in practice. The document does not replace RDC No. 1,015/2026 and has no normative force. Even so, it serves as a relevant reference for understanding the current position of the technical area responsible for reviewing AS applications. The answers should be read together with the resolution and the other sanitary rules cited in each case.

Applications Filed Under RDC No. 327/2019

One of the first issues addressed concerns AS applications filed before RDC No. 1,015/2026 came into force.

According to Anvisa, applications filed up to May 3, 2026 will continue to be reviewed under RDC No. 327/2019. A company may choose to update its application to RDC No. 1,015/2026 through an amendment, provided the amendment is filed before technical review of the petition begins and covers full compliance with the requirements of the new resolution. The document therefore does not allow a company to cherry-pick only the more favorable provisions of each regime, nor to submit a partial adaptation of the dossier. (Item 1)

Deciding whether to keep an AS application under RDC No. 327/2019 or fully migrate it to RDC No. 1,015/2026 requires a case-by-case strategic assessment. In principle, staying under the previous regime avoids a full overhaul of the technical dossier to meet the new requirements of RDC No. 1,015/2026, but it also subjects the product to the deadlines and other constraints of RDC No. 327/2019 itself — such as barring renewal of the AS upon expiration (forcing the manufacturer to seek registration as a medicine after five years); limiting presentation forms to oral or nasal routes only; imposing absolute advertising restrictions; and prohibiting the use of a trade name.

Migrating to the RDC No. 1,015/2026 regime may be advantageous for companies that already have documentation, certifications, and operational structures compatible with the new rule, which, for example, allows at least one AS renewal, expands the routes of administration (inhalation, oral, buccal, sublingual, and dermatological), permits advertising of the product to prescribing physicians and dispensing pharmacists, and allows for the future use of trade names, pending specific regulation.

The decision to remain under the previous regime or migrate will therefore depend on the product’s characteristics, the stage of dossier preparation, and how mature the production chain is relative to the requirements introduced by RDC No. 1,015/2026.

Good Manufacturing Practices Certification

Anvisa’s consolidated answers show that the Agency will apply a regulatory standard to cannabis products very close to that required for medicines, particularly regarding Good Manufacturing Practices, quality control, analytical validation, and stability studies.

The Agency clarified that equivalent foreign certificates will not be accepted in place of the GMP Certificate (“CBPF”) issued by Anvisa itself. It also clarified that the certification must be valid, correspond to the product’s production line and pharmaceutical form, and have been requested by the same company applying for the Health Authorization. A certification obtained by a different company, even if referring to the same manufacturing facility, is not sufficient to meet the regulatory requirement. (Items 15 and 16)

Good Manufacturing Practice certificates applicable to food, dietary supplements, or other regulatory categories will likewise not be accepted; what is required is a medicine-grade CBPF issued by Anvisa. In practice, foreign manufacturers currently operating under regulatory standards specific to food, dietary supplements, or equivalent categories will need to adapt their facilities and obtain Anvisa certification before entering the Brazilian market. (Item 19)

Who May Apply for the Health Authorization

The Health Authorization cannot be requested by just anyone. The document reinforces that the AS may only be requested by companies (legal entities) that meet the requirements expressly set out in RDC No. 1,015/2026 — another point where the framework moves closer to the sanitary regime applicable to regulated health products.

For domestic manufacturing, the applicant must hold a Company Operating Authorization (“AFE”), a Special Authorization (“AE”) to manufacture medicines, and a valid CBPF. Importers, in turn, must hold an AFE, an AE, and a Good Distribution and Storage Practices Certificate (“CBPDA”).

As is already the case for medicines, a distributor that is neither a manufacturer nor an importer under the terms of RDC No. 1,015/2026 cannot hold the Health Authorization, even if it holds an AFE, AE, and CBPDA. As for patient associations, the document makes clear that they are not exempt from the requirements of RDC No. 1,015/2026. A patient association could therefore only request the Health Authorization if, as the applicant legal entity, it fully met the same regulatory requirements required of manufacturers or importers. (Items 10, 11, 24, and 25)

Product Composition and Classification

RDC No. 1,015/2026 does not indiscriminately cover every product containing cannabis-derived substances. The regulation moves away from a broad concept of “cannabis product” and instead more precisely defines which active pharmaceutical ingredients can support a Health Authorization application, significantly narrowing the universe of formulations covered by the rule.

The product must contain, as its active ingredient, the phytopharmaceutical CBD at the required purity level, or an extract obtained from CBD-dominant chemotype Cannabis sativa L. When the product uses purified CBD as the Active Pharmaceutical Ingredient (“API”), the quality requirements applicable to specific medicines apply in addition. When it uses an extract as the Plant-derived Active Pharmaceutical Ingredient (“IFAV”), the quality rules applicable to herbal medicines apply.

The rule does not permit the use of synthetic or semi-synthetic cannabidiol as an active ingredient. Nor does it allow mixing isolated CBD with cannabis extract in the same formulation, or combining different phytopharmaceuticals or extracts. Products with these characteristics fall outside the scope of RDC No. 1,015/2026 and may, where applicable, be assessed through another regulatory path.

Formulations with equivalent or close concentrations of CBD and THC — such as 1:1 ratio products — likewise fall outside RDC No. 1,015/2026. This is because the extract permitted under the rule must come from a CBD-dominant chemotype, with a CBD concentration at least five times higher than THC. Such products may instead be assessed through the medicine registration pathway, subject to the applicable rules.

Other cannabinoids may be present when they are naturally part of the extract used as the IFAV. In that case, the active pharmaceutical ingredient remains the extract itself, not each cannabinoid individually. The company must characterize the extract’s composition and present the corresponding technical-scientific justification during product development, in accordance with the documentary requirements set out in the regulation. (Items 34, 38, 39, and 40)

The 0.2% and 0.3% THC Limits

The publication of the cultivation-related rules raised questions about the coexistence of the 0.2% and 0.3% THC limits. According to Anvisa, the two percentages refer to distinct regulatory subjects. The 0.3% THC limit relates to plant cultivation, following the parameter adopted in the STJ ruling, while the 0.2% limit under RDC No. 1,015/2026 concerns the THC content of cannabis products subject to the Health Authorization regime. There is therefore no conflict between the two parameters, since each governs a different stage of the regulatory chain.

The 0.2% threshold is not, however, an absolute prohibition. Products with a higher THC concentration may be authorized in the exceptional cases provided for under RDC No. 1,015/2026, provided they are intended for the indications set out therein and comply with the applicable technical justifications, warnings, use restrictions, and other regulatory requirements. The extract used must still come from a CBD-dominant chemotype. (Item 41)

Outsourcing of Activities

This area closely mirrors the regulatory approach applicable to medicines: outsourcing remains permitted, but it does not relieve the AS holder of responsibility, nor does it remove the sanitary requirements applicable to contracted service providers.

The manufacturer may outsource one or more stages of production, but not the entire production process. The contracted company must be duly authorized for the outsourced activity and hold a valid medicine-grade CBPF for the corresponding production line and pharmaceutical form.

The importer may outsource storage, transportation, quality control testing, and stability studies. For storage and transportation, contracted companies must hold a CBPDA. For quality control testing and stability studies, accreditation with the Brazilian Network of Health Analytical Laboratories (“REBLAS”) or a medicine-grade CBPF is required, depending on the activity performed.

Taken together, these clarifications show that outsourcing does not allow a structure in which the Health Authorization holder performs only a formal role. The applicant company must meet the regulatory requirements specific to the activity it performs and remains responsible for complying with the sanitary requirements applicable to the product and the contracted chain. (Items 6, 7, and 22)

Between Market Expansion and Growing Complexity

The new regulatory framework does not equate cannabis products with medicines. Nor does it eliminate the transitional nature of the Health Authorization. The bar, however, has been raised in terms of the technical, documentary, and operational demands applicable to this regulatory category.

Companies already operating in the sector will need to assess the compatibility of their dossiers, manufacturers, outsourcing contracts, analytical methods, stability studies, and certifications with the new regulation. For new entrants, regulatory strategy must begin before filing the AS application — particularly in choosing the active ingredient, formulating the pharmaceutical form, selecting manufacturing sites, and choosing logistics and analytical chain partners.

Some of Anvisa’s answers carry particularly significant consequences: the impossibility of relying on a CBPF obtained by a different company; the non-acceptance of equivalent foreign certificates; the need for full compliance when migrating processes to the requirements of RDC No. 1,015/2026; the narrower scope of products covered by RDC No. 1,015/2026; and the prohibition on fully outsourcing manufacturing. These points may directly affect the cost, timeline, and even the viability of already-planned projects.

The new framework creates research and domestic production opportunities that did not previously exist under express regulation. At the same time, it preserves different regulatory regimes: products under Health Authorization, registered medicines, exceptional imports by individuals, and experimental projects run by patient associations.

The reorganization initiated in 2026 makes the regulatory environment more structured and clearer — but also more demanding. How the new rules play out in practice will depend on the review of the first applications, sanitary enforcement, and still-pending complementary regulations (such as the one that, for now, prohibits compounding).

[1] KAYA MIND. Anuário da Cannabis Medicinal 2025. Available at: https://kayamind.com/anuario-da-cannabis-medicinal-2025/. Accessed: Jul. 27, 2026.

[2] BRAZIL. National Health Surveillance Agency (Anvisa). Collegiate Board Resolution – RDC No. 1,015, of April 30, 2026. Provides for the Health Authorization of Cannabis products. Brasília: Anvisa, 2026.

[3] BRAZIL. National Health Surveillance Agency (Anvisa). Questions and Answers – Health Authorization of Cannabis Products (RDC No. 1,015/2026). Brasília: Anvisa, 2026.