Life Sciences & Healthcare Newsletter | January 2026

The Life Sciences and Healthcare Newsletter gathers monthly updated information on the main topics, laws, and regulations related to the life sciences and healthcare sector in Brazil and is an opportunity to access legal information and comments on relevant market issues.

Enjoy reading!

Demarest’s Life Sciences and Healthcare Team

This material is for informative purposes only, and should not be used for decision-making. Specific legal advice can be provided by one of our lawyers.

MAIN NEWS

Brazil’s Supreme Court submits beta version of National Healthcare Medication Platform to the National Council of Justice

On January 12, 2026, Brazil’s Supreme Court (“STF”) submitted to the National Council of Justice (“CNJ”) the beta version of the National Healthcare Medication Platform (“MedSUS”) – a system developed over 14 months by the Federal Regional Court of the 4th Region (“TRF4”).

The tool aims to comprehensively map the administrative flow of medicine requests within Brazil’s Unified Health System (“SUS”), from medical prescription to dispensing, in order to support decision-making and reduce litigation.

According to the STF, MedSUS seeks to:

• Address information gaps regarding the progress of administrative medicines requests;
• Ensure greater rationality in the exchange of data between prescribers, managers, and judges; and
• Identify funding responsibilities in advance, preventing claims from reaching the Judiciary prematurely.

The platform was created as a result of the STF’s decision on Topic No. 1234 – which discusses the Federal Government’s passive legitimacy and the jurisdiction of the Federal Court in proceedings that address the supply of medicines registered with the National Health Surveillance Agency (“ANVISA”) but not incorporated into the SUS framework. The platform was structured to consolidate official data, including from the Brazilian Medicines Ontology (“OBM”), the National Health Council (“CNS”), and the price list of the Medicines Market Regulation Chamber (“CMED/ANVISA”). The aim is to enable prescribers, administrators, and judges to access a unified overview of the supply chain, thereby supporting more rational and technically informed administrative decisions before claims reach the Judiciary.

It will now fall into the CNJ to establish business rules, operational flows, and response deadlines to guide the system’s use by federal entities. Although the submitted version is functional, full national implementation will depend on the publication of operational instructions and the consolidation of internal procedures through a process that will be continuously monitored by the STF.

The expectation is that, by standardizing data and allowing qualified queries, the platform will strengthen judicial control, increase decision predictability, and contribute to SUS’ sustainability by improving information flow.

ANVISA approves regulations on cannabis production, in compliance with the Brazil’s Superior Court of Justice decision

On January 28, 2026, during the 1st Ordinary Public Meeting of the Collegiate Board of Directors (“DICOL”) of 2026, ANVISA unanimously approved new resolutions that comprehensively regulate the production of cannabis for exclusively medicinal and pharmaceutical purposes in Brazil.

The regulations were issued to comply with a decision of the Superior Court of Justice (“STJ”), handed down in November 2024, which recognized the legality of cultivating and processing the plant to safeguard the right to healthcare.

According to ANVISA, the new regulatory framework aims to provide predictability, security, and rationality to production activities, balancing the expansion of patient access with strict sanitary controls and alignment with the international obligations undertaken by Brazil under the United Nations (“UN”) conventions.

The resolutions approved and already published by ANVISA are structured in four Collegiate Board Resolutions (“RDCs”) aimed at:

• Updating the rules for manufacturing, importing, and marketing cannabis products for medicinal purposes;
• Cultivating Cannabis sativa L. for medicinal and/or pharmaceutical purposes;
• Cultivating Cannabis sativa L. for scientific research purposes; and
• The Experimental Regulatory Environment (“Regulatory Sandbox”).

Below are the key points of ANVISA’s new regulatory framework:

1. Manufacture, import, and commercialization
   RDC No. 1,015/2026 addresses the sanitary authorization for the manufacture and import of cannabis products for human medicinal use and establishes requirements for their sale.Among the key aspects introduced by the resolution, we highlight the following:
   • Expansion of the forms of administration of cannabis products to include dermatological, sublingual, oral, and inhalation use.
   • Authorization for compounding pharmacies to prepare cannabis-based products – subject to a specific regulation yet to be approved and published by ANVISA.
   • Inclusion of patients suffering from severe debilitating diseases, such as fibromyalgia and lupus, in the list of individuals authorized to use cannabis-based products with tetrahydrocannabinol (“THC”) concentrations above 0.2%.
   • Expansion of the list of healthcare professionals authorized to prescribe these products, including dental surgeons.

   RDC No. 1,015/2026 comes into force on May 04, 2026, and repeals RDC No. 327/2019.

    

2. Cultivation of Cannabis sativa L. for medicinal and/or pharmaceutical purposes
   RDC No. 1,013/2026 establishes the regulatory framework for the cultivation of Cannabis sativa L. with THC content not exceeding 0.3% intended exclusively for medicinal and/or pharmaceutical purposes.The main provisions include:
   • To be able to carry out the activities provided for in RDC No. 1,013/2026, each facility must obtain a Special Authorization (“AE”) that expressly includes the cultivation of Cannabis sativa L., and implement traceability, control, and monitoring mechanisms.
   • Import and export operations involving Cannabis sativa L.with a THC up to 0.3% (including seeds) must comply with Brazil’s Ministry of Agriculture and Livestock (“MAPA”) requirements, including documentation attesting to the genetic origin of the plant species capable of producing a THC content that does not exceed 0.3%.
   • Mandatory laboratory analysis of the THC content of all batches cultivated by the facility.
   • Immediate suspension of activities and destruction of the crop in the event of irregularities or deviations from the required standard.

   RDC No. 1,013/2026 comes into force on August 04, 2026.

    

3. Cultivation of Cannabis sativa L. for scientific research purposes
   RDC No. 1,012/2026 regulates the cultivation of Cannabis sativa L. intended exclusively for scientific research. Under the resolution, only duly licensed legal entities in the following categories may engage in the activities provided for in this resolution:
   • Higher or technical education institutions recognized by Brazil’s Ministry of Education (“MEC”);
   • Scientific, Technological, and Innovation Institutions (“ICTs”);
   • Entities holding an AE for the activity of manufacturing pharmaceutical ingredients or medicines; and
   • State defense or drug enforcement agency or institution.

   The requirements applicable to these players include:

   • Mandatory AE for cultivation, covering planting, growing, handling, transferring, donating, importing, exporting, and storing, and processing of the plant species, up to product development, including research conducted with the resulting co‑products for any research‑exclusive purpose.
   • Obligation to ensure the traceability of the Cannabis sativa L. plant species, from the acquisition of seeds and mother plants to processing or final disposal.
   • Mandatory bookkeeping in a specific registry book documenting all transactions, including inflows, outflows, and inventory control at each stage, in compliance with SVS/MS Ordinance No. 344/1998.
   • Prohibition on the commercialization of the plant species and products arising from research, with only shipment or donation permitted between institutions previously authorized by ANVISA to conduct analyses and other research‑related activities.

   RDC No. 1,012/2026 will come into force on August 04, 2026.

    

4. Regulatory Sandbox

RDC No. 1,014/2026 establishes the Regulatory Sandbox for the controlled testing of experimental techniques and technologies involving health oversight regulated products or services related to the combination of the following activities within the scope of Cannabis sativa L.:

• Cultivation for medicinal purposes;
• Production of plant-derived pharmaceutical ingredients; and
• Development, preparation, and supply of cannabis-based products for medicinal use.

The Regulatory Sandbox is based on Complementary Law No. 182/2021 and consists of an experimental, exceptional, and temporary environment in which companies can test, in a controlled and supervised manner, new technical, productive, and operational arrangements. Within this space, participants can receive temporary authorization to develop and produce – under real and controlled conditions – innovative products or services.

Participation in the Regulatory Sandbox, established by RDC No. 1,014/2026, will depend on selection through a public call for contributions, through a notice to be published by ANVISA.

PUBLISHED REGULATIONS

• BRAZILIAN HEALTH REGULATORY AGENCY (“ANVISA”)

RDC No. 1,011/26: Provides for the update of Annex I (Lists of Narcotics, Psychotropics, Precursors, and Other Substances under Special Control) of SVS/MS Ordinance No. 344, of May 12, 1998.

RDC No. 1,012/26: Provides for the requirements for the cultivation of the plant species Cannabis sativa L., intended exclusively for research purposes.

RDC No. 1,013/26: Provides for the requirements for the cultivation of the plant species Cannabis sativa L. with THC content not exceeding 0.3%, intended exclusively for medicinal and/or pharmaceutical purposes.

RDC No. 1,014/26: Establishes the Regulatory Sandbox for controlled testing of activities related to cannabis for medicinal purposes.

RDC No. 1,015/26: Provides for sanitary authorization for the manufacture and import of cannabis products for human medicinal use and establishes requirements for commercialization.

• BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2,452/26: Provides for the end of the administrative intervention in the Regional Council of Medicine of the State of Rio de Janeiro (“CREMERJ”) and the inauguration of the new elected board of directors.

• FEDERAL COUNCIL OF BIOMEDICINE (“CFBM”):

CFBM Resolution No. 418/26: Repeals CFBM Resolution No. 288 of March 15, 2018 (which regulates the registration of podiatry technologists and podiatry technicians in the healthcare and related areas), by virtue of a final and unappealable court decision.

SOCIAL PARTICIPATION

ANVISA Public Consultation (“CP”) No. 1,376/26: Proposal to update the Brazilian Homeopathic Pharmacopoeia, with the inclusion of new pharmacopeial texts, revision of existing texts, and exclusion of pharmacopeial texts.

Contribution deadline: March 16, 2026

ANVISA CP No. 1,377/26: Proposal to update the National Form of the Brazilian Pharmacopoeia, with the inclusion of new pharmacopeial texts and revision of existing texts.

Contribution deadline: March 16, 2026

ANVISA CP No. 1378/26: Proposal to update the Brazilian Pharmacopoeia, including the addition of the monographs Colônia (leaf), Plantago (leaf), and Solidago (aerial parts), revision of general method 5.4.1.2 – Sensory examination and microscopic inspection of herbal medicines – and the revision of the monographs Prunus domestica (fruit and fluid extract).

Contribution deadline:  March 04, 2026

ANVISA CP No. 1379/26: Proposal to update the Brazilian Pharmacopoeia to revise general methods 5.1.4.1 Disintegration test for tablets and capsules, 5.5.3.3 Microbiological testing of antibiotics, 5.5.3.3.1 Microbiological testing by agar diffusion, and 5.5.3.3.2 Microbiological testing by turbidimetry.

Contribution deadline:  March 04, 2026

ANVISA CP No. 1380/26: Proposal for a resolution by the Collegiate Board of Directors to establish technical requirements and good practices for the fractioning of products and the reuse of packaging for personal hygiene products, cosmetics, and perfumes sold directly to consumers.

Contribution deadline: March 20, 2026

ANVISA CP No. 1381/26: Proposal for a normative instruction to establish the categories of personal hygiene products, cosmetics, and perfumes that can be subject to fractionation, with or without reuse of packaging and direct sale to the consumer.

Contribution deadline: March 20, 2026

ANVISA CP No. 1382/26: Proposed normative instruction that adds the agricultural use modality (acaricide) and updates the toxicological characteristics in Monograph G07 – Geraniol, within the List of Active Ingredients for Pesticides, Disinfectant Sanitizing Agents, and Wood Preservatives, published through Normative Instruction (“IN”) No. 103, of October 19, 2021.

Contribution deadline: March 20, 2026

ANVISA CP No. 1383/26: Proposal to include a monograph in the List of Active Ingredients for Pesticides, Disinfectant Sanitizing Agents, and Wood Preservatives, published through IN No. 103, of October 19, 2021.

Contribution deadline: March 21, 2026