Life Sciences and Healthcare Newsletter | March 2025

The Life Sciences and Healthcare Newsletter brings information and news on the key issues and recent legislation related to the life sciences and healthcare sector in Brazil. This initiative encompasses transactional and regulatory industry matters and invites all market players to access relevant news of the sector and our comments on such topics.

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

ANVISA opens public consultation to update Cannabis products’ regulation

On March 27, 2025, the Brazilian Health Regulatory Agency (ANVISA) published Public Consultation No. 1316/25.

CP 1316 proposes the revision of Collegiate Board Resolution (RDC) No. 327/19, which establishes procedures for granting health permits for producing and importing Cannabis products for medicinal purposes, as well as sale, prescription, dispensing, monitoring, and inspection requirements.

Interested parties can contribute to the public consultation by June 02, 2025 through ANVISA’s website.

RDC No. 327/19 was published as a temporary alternative to legitimize Cannabis products given the Brazilian market’s increasing demand for such items. In this regard, the resolution established the health permit as a unique simplified procedure and provided for the permit holder’s obligation to request the marketing authorization as a medicine within five years from the date when the permit was granted. This deadline cannot be extended.

For more information, please access Demarest’s Client Alert.

ANVISA conducts sectoral discussions on plant-based, infant, transition foods, and therapeutic diet foods for inborn errors of metabolism

 On March 13, 2025, ANVISA held two sectoral discussions to address essential regulatory matters in the food industry:

Infant, transitional and therapeutic diet foods

The sectoral discussion presented the technical department’s conclusions after assessing contributions received in:

• Public Consultation No 1242/24, which proposes a new RDC on health requirements for these products ; and
• Public Consultation 1243/24, which proposes a new normative instruction (IN) on the composition and quality requirements, content and nutritional claims, and list of authorized ingredients for these products.

Plant-based foods

The second discussion concentrated on the regulation of plant-based foods, and presented activities executed by ANVISA in 2024, in addition to a regulatory process proposal to be submitted for the collegiate board’s approval in 2025.

Plant-based foods are those that originate from plant sources such as fruits, vegetables, whole grains, nuts, seeds and legumes. ANVISA has been working towards updating the regulation of these products to ensure safety and clear information for consumers.

New ANVISA resolution updates good pharmacovigilance practices

On March 20, 2025, ANVISA published RDC No. 967/25, which updates the resolution on good pharmacovigilance practices for marketing authorization holders (MAH) (RDC No. 406/20).

Main changes:

• Sistema VigiMed: MAH must notify adverse events through the VigiMed electronic system following the E2B(R3) guideline of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Notifications can be submitted manually or by importing compatible XML files.
• Data coding: When submitting reports and notifications to the Brazilian Health Regulatory System (SNVS), the MAH must use the Medical Dictionary for Regulatory Activities (MedDRA) to code encode medical terms and adverse events, and the WHODrug Global dictionary to code medicines, including vaccines.
• Supporting documentation: The MAH must comply with regional requirements and supporting documentation publicized on ANVISA’s website, including the VigiMed Empresas user’s guide and the ICH’s E2B guideline for creating XML files.

These changes will enter into force on March 20, 2026, enabling companies to adjust to the new provisions.

Ministry of Health announces innovative gene therapy through SUS

On March 20, 2025, the Ministry of Health entered into an unprecedented risk-sharing agreement with pharmaceutical company Novartis.

The agreement is based on the performance of medicine Zolgensma, used in the treatment of type 1 spinal muscular atrophy (SMA). As such, medicine costs will be subsidized according to patients’ results:

• 40% of the total price at the time of infusion therapy;
• 20% after 24 months, if the patient regains control of their neck;
• 20% after 36 months, if the patient can control their torso (sit for at least 10 seconds without support);
• 20% after 48 months, if the patient can maintain any achieved motor improvements.

The agreement also sets out that future installments of the subsidy will be canceled if the patient dies, or the disease progresses to a long-term mechanical ventilation stage.

Since the last week of March, 2025, patients can undergo preparatory testing in the 28 SMA reference treatment units of the Brazilian Unified Health System (SUS).

For more information: Ministry of Health announces innovative gene therapy through SUS

CMED publishes resolution on medicine price increase

On March 31, 2025, Brazil’s Drug Market Regulation Chamber (CMED) published CMED Resolution No. 01/25, provides for the maximum increase of medicine prices as of March 31, 2025, the submission of a marketing report to CMED, and the publicity of pharmaceutical product prices.

Primary topics of the resolution:

• Price increase: MAH holders can increase prices as of March 31, 2025. Such increase must follow the latest Factory Price (Preço Fábrica) published on CMED’s page on ANVISA’s website.
• Increase limits: Maximum price increase levels are divided into three levels:
• Level 1: 5.06%
• Level 2: 3.83%
• Level 3: 2.60%
• Sales report: All MAH must submit a sales report to CMED detailing the company’s sales and revenue. The company will be subject to penalties provided by law if it fails to submit the report or submits it late or with inconsistencies.

Brazilian Federal Pharmacy Council authorizes pharmacists to prescribe prescription medicines; Federal courts suspend resolution until final decision

On March 17, 2025, the Brazilian Federal Pharmacy Council (CFF) published CFF Resolution No. 05/25, which provides for the establishment of patients’ pharmacotherapeutic follow-up profiles by pharmacists, among other provisions.

The resolution authorizes pharmacists to prescribe medicines according to patients’ pharmacotherapeutic profiles based on regular follow-ups, according to Law No. 13,021/14, which provides for the practice and supervision of pharmaceutical activities.

In addition, the CFF published CFF Resolution No. 04/25, which provides for the Specialist Qualification ID (RQE) for pharmacists. The pharmaceutical professional must register their specialties with the regional council by presenting diplomas and certificates of recognized training, including postgraduate degrees, residencies, or training programs, in addition to meeting the criteria defined in the new resolution.

Suspension

On March 20, 2025, the Brazilian Federal Medicine Council (CFM) filed Public-Interest Civil Action (ACP) No. 1024895-51.2025.4.01.3400 against the CFF, requesting the immediate suspension of the new resolution and that the CFF be banned from enacting further regulations on the matter. According to the CFM, CFF Resolution No. 05/25 seeks to “subvert the legal order to keep the content of CFF Resolution 586/13 in force”.

On March 31, 2025, the 17th Civil Federal Court of the Judicial District of the Brazilian Federal District granted a preliminary injunction filed by the CFM to suspend the new CFF resolution until a final ruling on the matter is issued.

For more information: Brazilian Pharmacy Council authorizes pharmacists to prescribe prescription medicines and establishes Specialist Qualification ID

PUBLISHED NORMATIVE ACTS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA):

RDC No. 967/25: Updates RDC No. 406/20, which provides for the Good Practices of Pharmacovigilance for Human Use Medicine Marketing Authorization Holders, among other provisions.

RDC No 968/25: Extends RDC No. 567/21, which provides for the temporary and exceptional criteria and procedures for importing industrialized radiopharmaceuticals listed in ANVISA Normative Instruction No. 81/20 and its updates, due to the risk of supply shortage in Brazil.

RDC No 969/25: Updates RDC No 8/14, which authorizes the import of medicinal products listed on the list of medicinal products authorized for import as an exception, intended solely for hospital use or upon medical prescription, and whose import is linked to a particular hospital entity and/or representative civil entity linked to the healthcare area, for its own exclusive use, and not intended for resale or trade.

RDC No. 970/25: Provides for the update of Annex I (Lists of Narcotics, Psychotropic Drugs, Drug Precursors and Others under Special Control) of SVS/MS Ordinance No. 344, of May 12, 1998.

RDC No 971/25: Updates RDC No. 947 24/, which provides for the procedures to file documents within the scope of ANVISA.

IN No. 347/25: Provides for the update of monographs of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizes and Wood Preservatives, published in IN No. 103/21.

IN No. 348/25: Provides for the inclusion of the monograph of active ingredient C92 – CHROMOBACTERIUM SUBTSUGAE in the list of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/21.

IN No. 349/25: Provides for the inclusion of the monograph of active ingredient B70 – BACULOVIRUS ERINNYIS ELLO in the list of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/21.

IN No. 350/25: Provides for the update of the monographs of the active ingredients of the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/21.

IN No. 351/25: Updates IN No. 160/22, which establishes the maximum authorized limits for contaminants in food.

IN No. 352/25: Updates IN No. 1/14, which provides for the list of medicines authorized for import as an exception.

IN No. 353/25: Publishes the Reference Listed Drugs .

IN No. 354/25: Provides for the update of monographs of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/21.

IN No. 355/25: Provides for the update of the list of Brazilian Common Denominations (DCB).

BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY (“ANS”):

RN No. 628/25: Updates Normative Resolution (RN) No. 465, of February 24, 2021, which provides for the list of mandatory health events and procedures in supplementary healthcare, to regulate the mandatory coverage of immunobiological medicine Bimekizumab, for treating moderate to severe psoriasis in adults, in compliance with the provisions of paragraphs 4, 7 and 8 of article 10 of Law No. 9,656/1998.

RN No. 629/25: Updates Normative Resolution (RN) No. 465, of February 24, 2021, which provides for the list of mandatory health events and procedures in supplementary healthcare, to regulate the mandatory coverage of the medicine Ponatinib for treating chronic myelocytic leukemia (myeloid, myelogenous, granulocytic), in the chronic, accelerated or blast phases, with failure/resistance or intolerance to second-generation tyrosine kinase inhibitors, referring to the ORAL ANTINEOPLASTIC THERAPY PROCEDURE FOR CANCER TREATMENT (WITH USE GUIDELINES); and to update the mandatory coverage of the procedure for CLASSICAL FABRY DISEASE THERAPY (WITH USE GUIDELINE), to establish mandatory coverage of the medicine Algasidase beta in patients aged seven years or older, in compliance with the provisions of paragraphs 4 and 10 of article 10 of Law No. 9,656/1998.

MINISTRY OF HEALTH (“MS”):

GM/MS Ordinance No. 6656/25: Provides for mandatory periodic submission of SUS Healthcare Regulation data.

GM/MS Ordinance No. 6686/25: Establishes the collegiate board of the Ministry of Health to monitor, evaluate and strengthen the implementation of strategic actions and targets of the Ministry of Health within the scope of SUS.

GM/MS Ordinance No. 6734/25: Updates Exhibit 1 of Annex V of the GM/MS Consolidation Ordinance No. 4/17, to include human sporotrichosis in the National List of Mandatory Notification of Diseases, Health Risks and Public Health Events in public and private healthcare services across Brazilian territory.

DEPARTMENT OF SCIENCE, TECHNOLOGY AND INNOVATION AND OF THE ECONOMIC-INDUSTRIAL HEALTHCARE COMPLEX (SECTICS)

SECTICS Ordinance No. 15/25: Publicizes the decision to incorporate nirsevimab within SUS in the prevention of lower respiratory tract infection associated with respiratory syncytial virus, for premature infants under 37 weeks and children under 2 years old with comorbidities, according to the Clinical Protocol of the Ministry of Health.

BRAZILIAN FEDERAL MEDICINE COUNCIL (CFM):

CFM Resolution No. 2423/25: Establishes the intervention by the CFM in the Regional Council of Medicine of the State of Rio de Janeiro, and appoints the members of the provisional intervention board, among other provisions.

FEDERAL PHARMACY COUNCIL (CFF):

CFF Resolution No. 3/25: Provides for the pharmacist’s practice within the scope of aromatherapy, aromatology and essential oils, among other provisions.

CFF Resolution No. 4/25: Provides for the creation of the Specialist Qualification Identification (RQE), and establishes criteria and procedures for pharmacists to obtain it.

CFF Resolution No. 5/25: Provides for the establishment of patients’ pharmacotherapeutic follow-up profiles by pharmacists, among other provisions.

CFF Resolution No. 6/25: Regulates the pharmacist qualification in Mental Health.

CFF Resolution No. 7/25: Regulates the pharmacist qualification in Women’s Health with emphasis on the prescription of hormonal contraceptives.

FEDERAL COUNCIL OF BIOMEDICINE (CFBM):

CFBM Resolution No. 392/25: Provides for the responsibilities and rights of the biomedical scientist qualified in Clinical Research, Health Product Development, and Healthcare Technology Innovation.

FEDERAL COUNCIL OF BIOLOGY (CFBIO):

CFBio Resolution No. 725/25: Provides for the procedures and manual aesthetic techniques of biologists qualified in Biology of Aesthetics, among other provisions.

CFBio Resolution No. 726/25: Provides for the use of equipment and aesthetic procedures used by biologists qualified in Biology of Aesthetics, among other provisions.

DRUGS MARKET REGULATION CHAMBER (CMED):

CM-CMED RESOLUTION No. 01/25: Provides for the maximum price increase for medicines as of March 31, 2025; the submission of a sales report to CMED; and the publicity of pharmaceutical product prices.

SOCIAL PARTICIPATION

ANVISA Public Consultation No. 1313/25: To receive contributions on the normative instruction proposal that establishes requirements for the Unique Device Identification (UDI) database transmission and management, as provided for in RDC No. 591/21.

Contribution deadline: May 26, 2025

ANVISA Public Consultation No. 1314/25: To receive contributions on the proposed normative instruction that includes the active ingredient B71 – BACILLUS INAQUOSORUM in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/21.

Contribution deadline: June 01, 2025

ANVISA Public Consultation No. 1315/25: To receive contributions on the proposed normative instruction that includes the active ingredient S25 – STREPTOMYCES GRISEOVIRIDIS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/21.

Contribution deadline: June 01, 2025

ANVISA Public Consultation No. 1316/25: To receive contributions on the proposed revision of RDC No. 327/19, which establishes the procedures for granting a health permit for producing and importing, and also sets requirements for the marketing, prescription, dispensing, monitoring and auditing of Cannabis Products.

Contribution deadline: June 02, 2025

ANVISA Public Consultation No. 1317/25: To receive contributions on the proposed regulation that provides for the health requirements applicable to food-grade post-consumer recycled polyethylene terephthalate (PET-PCR) used in precursors and packaging that will be in contact with food.

Contribution deadline: May 19, 2025

Public Call Notice No. 04/25: To obtain contributions on the M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol.

Contribution deadline: April 28, 2025

ANS Public Consultation No. 152/25: To receive contributions on the preliminary recommendation of non-incorporation for technologies contained in UAT No. 144 (Dupilumab); UAT No. 149 (NGS Panel for Circulating Tumor DNA [ctDNA]; and UAT No. 150 (Sotorasib).

Contribution deadline: March 25, 2025

SECTICS Public Consultation No. 11/25: To receive contributions on the proposal to approve e Clinical Protocol and Therapeutic Guidelines of Systemic Arterial Hypertension, presented by SECTICS in the records of NUP 25000.136513/2021-11.

Contribution deadline: April 02, 2025

SECTICS Public Consultation No. 12/25: To receive contributions on the proposal to incorporate amniotic membrane transplantation into the treatment of patients with skin burns, presented by the Department of Specialized Healthcare (SAES/MS) in the records of NUP 25000.091946/2023-01.

Contribution deadline: April 02, 2025

SECTICS Public Consultation No. 13/25: To receive contributions on the proposed update of the Clinical Protocol and Therapeutic Guidelines for Axial Spondyloarthritis, presented by the Department of Science, Technology and Innovation and Economic-Industrial Complex of Health (SECTICS/MS) in the records of NUP 25000.048331/2022-75.

Contribution deadline: April 02, 2025

SECTICS Public Consultation No. 14/25: To receive contributions on the proposed update of the Clinical Protocol and Therapeutic Guidelines for Acromegaly, presented by the Department of Science, Technology and Innovation and Economic-Industrial Complex of Health (SECTICS) in the records of NUP 25000.090386/2023-69.

Contribution deadline: April 02, 2025