Life Sciences and Healthcare Newsletter | July 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

Ministry of Health opens public consultation on proposed “One Health” action plan

On July 18, 2025, the Ministry of Health launched Public Consultation No. 2/25 to receive contributions on the proposed “One Health” National Action Plan by August 18, 2025.

This initiative aims to establish an integrated approach to human, animal, plant, and environmental health, emphasizing multidisciplinary cooperation for epidemic prevention, zoonoses control, food safety, and antimicrobial resistance prevention.

The plan draws inspiration from the Quadripartite Alliance, formed by the World Health Organization (WHO), the World Organisation for Animal Health (WOAH), the Food and Agriculture Organization of the United Nations (FAO), and the United Nations Environment Programme (UNEP). The proposal envisions joint action by approximately 70 institutions, including:

• The Brazilian Ministries of Health (MS); of Agriculture (MAPA); of Defense (MD); and of the Environment and Climate Change (MMA).
• Authorities such as the Brazilian Health Regulatory Agency (ANVISA), the Oswaldo Cruz Foundation (FIOCRUZ); and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA); and
• Professional boards such as the Federal Councils of Medicine (CFM), Veterinary Medicine (CFMV), the Pharmacy (CFF), and Biology (CFBIO).

The proposal also provides for seven high-level targets: Promoting institutional consolidation, health risk mitigation, preventing and controlling zoonostic diseases, improving food safety, tackling antimicrobial resistance, integrating environmental actions, and encouraging social participation. Given Brazil’s strategic position in the global landscape, the plan seeks to improve the national regulatory framework by aligning technical criteria with international standards, simplifying procedures, and developing more objective, efficient, and evidence-based regulations.

For more information, read our Client Alert (PT).

Government bans animal testing of cosmetics, perfumes, personal hygiene products and their ingredients

On July 31, 2025, the Federal Government enacted Law No. 15,183/2025, prohibiting the use of vertebrate animal testing to assess the safety, efficacy, and hazards of personal hygiene products, cosmetics, perfumes, and their ingredients.

Changes highlighted in the new law include:

• Data from animal testing conducted after the law entered into force (July 31, 2025) can only be used if obtained to comply with non-cosmetic Brazilian or international regulations. This exception applies only if companies can provide documentation upon the authorities’ request to prove that such tests do not have cosmetic purposes.
• Manufacturers must not use “not tested on animals” or “cruelty free” claims, logos, or seals on products whose safety was established using animal testing data obtained after the law entered into force, whether or not obtained to comply with non-cosmetic Brazilian or international regulations.

 Within two years and within their respective competencies, ANVISA and the National Council for the Control of Animal Experimentation (CONCEA) must:

• Regulate alternative methods for assessing the safety, efficacy, or hazard of cosmetics and related products, including reliance initiatives to implement internationally recognized and validated methods;
• Update labeling regulations considering the ban on “cruelty free” or “not tested on animals” claims on products tested on animals;
• Implement measures to oversee the use of animal testing data in safety evaluation and product registration after Law No. 15,183/2025 entered into force.

Law No. 15,183/2025 does not affect products registered before its entry into force, whose sale remains authorized in Brazil.

However, data from animal testing conducted before July 31, 2025, may still be used for product registration with ANVISA. From that date onward, data from animal testing may only be used for registration purposes if obtained to comply with non-cosmetic Brazilian or international regulations.

Finally, we highlight that ANVISA accepts alternative testing methods recognized by CONCEA, as specified in CONCEA Normative Resolutions No. 18/2014 and No. 31/2016, in accordance with ANVISA Collegiate Board Resolution (RDC) No. 35/2015.

Law No. 15,183/2025 entered into force on July 31, 2025.

For more information, read our Client Alert.

Anvisa proposes measure to reduce waste and provide financial relief to the food industry

On July 28, 2025, ANVISA published RDC No. 983/2025, introducing measures to promote the rational and efficient use of resources, protecting food safety and preventing the unnecessary waste of inputs and packaging.

The new regulation updates RDC No. 843/2024 and applies to the following food categories:

1 – Dietary supplements to address inborn errors of metabolism

• Manufacturers who notified the start of production or import of these supplements before RDC No. 983/2025 entered into force must apply for marketing authorization with ANVISA by September 1, 2025.
• Supplements produced before the final marketing authorization decision may be sold until their respective expiration dates.
• Labels produced prior to the new law can also be used for up to 180 days after the favorable marketing authorization decision, solely to phase out existing packaging. No changes to product composition or labeling are allowed during this period, but the statement “Food registered with ANVISA” followed by the marketing authorization number may be absent.

2. Weight-control foods and food supplements:

Manufacturers who notified the start of production or importation before RDC No. 983/2025 entered into force must submit the required notification documents to ANVISA by September 1, 2025.

Products manufactured before the notification date on ANVISA’s electronic system may be sold until their expiration dates. Pre-produced labels may be used for up to 180 days after notification, solely to phase out existing packaging, provided no changes are made to composition or labeling.

3. Other relevant categories:

Labels for the following products may be used for up to 180 days after notification to ANVISA, solely to phase out existing packaging:

• Desalinated, potable, bottled seawater;
• Foods with functional or health claims;
• Transitional foods for infant nutrition;
• Cereals for infant feeding;
• Food grade PET-PCR resin, precursor articles, or final packaging;
• Dietary supplements containing probiotics or enzymes.

During this period, products must be properly registered and may not undergo changes in composition or labeling, except for the absence of the statement “Food notified to ANVISA” followed by the notification process number.

For more information, access: Anvisa authorizes use of pre-produced packaging after food regulation.

Government regulates the National Health Data Network and interoperability within SUS

On July 23, 2025, Decree No. 12,560 was published, regulating the National Health Data Network (RNDS) and the SUS Digital Platforms, seeking to bolster governance, interoperability, and data protection within the Brazilian Unified Health System (SUS).

The decree regulates Sections 47 and 47-A of Law No. 8,080/1990 and establishes guidelines for structured and secure data sharing between public and private entities.

The RNDS serves as the national interoperability platform for the SUS data ecosystem, integrating health, administrative, financial, and registration data across Brazil. Such data must be processed to support healthcare, oversight, management, research, and public policy implementation within the health area. In addition, data processing must comply with the principles of the Brazilian General Data Protection Law (LGPD), which includes assessing data protection impacts, prohibiting secondary use of data for incompatible purposes, and safeguarding data subject rights.

The decree also establishes the federalization of the RNDS, enabling decentralized access to data by states, the Federal District, and municipalities to ensure continuity of care. Governance of the network will be coordinated by the Ministry of Health, which will define technical standards, responsibilities, security measures, and transparency guidelines.

Ministry of Health launches public consultation to reformulate Brazil’s Clinical Research Action Plan

On July 30, 2025, the Ministry of Health announced Public Consultation SECTICS No. 69/2025, aimed at updating Brazil’s strategic Clinical Research Action Plan.

The consultation seeks to identify key challenges in conducting clinical research in Brazil, including regulatory and ethical aspects, and other significant information. The initiative aims to modernize the clinical research ecosystem, expand national capacity for conducting studies, and position Brazil as a national and international reference in clinical research and health innovation.

The consultation is open until September 18, 2025.

Interested parties can contribute in Public Consultation SECTICS/MS No. 69/2025 (PT).

ANVISA launches international public consultation on Good Manufacturing Practices for the pharmaceutical sector

On July 7, 2025, ANVISA announced an international public consultation to revise Good Manufacturing Practices (GMP) guidelines.

The initiative aims to align Brazilian standards with documents revised by the European Union and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), of which ANVISA is an active member.

The revised documents include:

• Chapter 4 of GMP, addressing documentation requirements, control criteria, and traceability;
• Annex 11, addressing the use of computerized systems in medicine production, with emphasis on validation and data security;
• The new Annex 22, outlining guidelines for implementing artificial intelligence, including algorithm validation, human oversight, and transparency in automated procedures.

The consultation is open until October 7, 2025, and ANVISA has emphasized that the pharmaceutical industry’s contributions will be essential to ensure that local demands are considered when aligning procedures with international practices.

Preliminary documents and submission templates are available on the European Commission and PIC/S websites. Questions may be directed to ggfis@anvisa.gov.br.

For more information, access ANVISA’s announcement.

PUBLISHED REGULATIONS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA)

RDC No. 985/25: 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, dated May 12, 1998.

RDC No. 984/25: Updates RDC No. 730/2022, which provides for human health risk assessment of veterinary medicines, maximum residue limits (MRL) in foods of animal origin, and analytical methods for compliance evaluation.

RDC No. 983/25: Updates RDC No. 843, dated February 22, 2024, which provides for the requirements to bring food products and respective packaging under the competence of the National Health Regulatory System’s (SNVS) in line with the applicable regulation for distribution in Brazil.

RDC No. 982/25: Establishes criteria for health risk management and company compliance monitoring for the initial issuance or renewal of Good Manufacturing Practices (GMP) or Good Distribution and/or Storage Practices certificates.

Normative Instruction (IN) No. 390/25: Updates IN No. 1, dated February 28, 2014, which provides for the list of medicines authorized for import as an exception.

IN No. 389/25: Sets temporary health measures for ports and airports in response to the current epidemiological situation, according to Section 12 and Section 19 of RDC No. 932/2024.

IN No. 388/25: Updates the List of Prescription-Free Medicines and publishes the list of denied applications.

IN No. 387/25: Provides for the inclusion of the monograph of active ingredient T84 – THYMUS VULGARIS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 386/25: Provides for the inclusion of the monograph of active ingredient P77 – PAENIBACILLUS OTTOWII in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 385/25: Provides for the inclusion of the monograph of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 384/25: Provides for the inclusion of the monograph of active ingredient B72 – BACULOVIRUS PLUTELLA XYLOSTELLA GRANULOVIRUS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 383/25: Provides for the update of the list of Brazilian Common Denominations (DCB).

IN No. 382/25: Provides for the inclusion of the monograph of active ingredient C39 – CYANAMIDE in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 381/25: Updates IN No. 162, dated July 1, 2022, which establishes the acceptable daily intake (ADI), the acute reference dose (ARfD), and the maximum residue limits (MRL) for active pharmaceutical ingredients (API) of veterinary medicinal products in foods of animal origin.

IN No. 380/25: Updates IN No. 211, dated March 01, 2023, which establishes the technological functions, limits and conditions of use for authorized food additives and processing co-formulants.

IN No. 379/25: Provides for the inclusion of the monograph of active ingredient S25 – STREPTOMYCES GRISEOVIRIDIS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 378/25: Updates the Reference Listed Drugs (“LMR”) in Brazil.

IN No. 377/25: Provides for the update of the composition of COVID-19 vaccines to be used in Brazil.

IN No. 376/25: Provides for the inclusion of the monograph of active ingredient B71 – BACILLUS INAQUOSORUM in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 375/25: Updates Normative Instruction No. 9, dated August 01, 2016.

NATIONAL SUPPLEMENTARY HEALTHCARE AGENCY (“ANS”):

RN No. 639/25: Repeals ANS Normative Resolution No. 551, dated November 11, 2022, and exempts healthcare plan operators from submitting information to the Product Information System (SIP).

RN No. 640/25: Updates Normative Resolution No. 574, dated February 28, 2023, which establishes the criteria for the constitution of technical provisions to be observed by private healthcare plan operators.

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

SECTICS Ordinance No. 47/25: Announces the decision to expand the use of the subdermal contraceptive implant containing etonogestrel within the scope of SUS, supplying it to adult women aged 18 to 49 years.

SECTICS Ordinance No. 48/25: Announces the decision to expand the use of the subdermal contraceptive implant containing etonogestrel within the scope of SUS, supplying it to teenagers aged 14 to 17 years.

SECTICS Ordinance No. 49/25: Announces the decision to approve the Clinical Protocol and Therapeutic Guidelines for Systemic Arterial Hypertension within the scope of SUS.

SECTICS Ordinance No. 50/25: Announces the decision to include tafenoquine 50 mg in SUS for the treatment of pediatric patients with malaria caused by Plasmodium vivax.

SECTICS Ordinance No. 51/25: Announces the decision to include blinatumomab in SUS  50 mg in SUS for the treatment of adult patients with B-cell acute lymphoblastic leukemia (ALL), Philadelphia chromosome-negative, with minimal residual disease (MRD) positivity, who have achieved complete remission, in accordance with the Ministry of Health’s protocol.

SECTICS Ordinance No. 52/25: Announces the decision to include blinatumomab in SUS  50 mg in SUS for the treatment of adult patients with B-cell acute lymphoblastic leukemia (ALL), Philadelphia chromosome-negative, with relapsed or refractory disease.

SECTICS Ordinance No. 53/25: Announces the decision not to incorporate the subcutaneous human plasma-derived C1 esterase inhibitor in SUS for long-term prophylaxis in patients with hereditary angioedema types I and II

BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2442/25: Establishes procedures for the granting of air or ground transportation, national and international per diems, representation allowance, jeton payments, and fuel reimbursement, in compliance with Law No. 11,000/2004. It also repeals previous resolutions on the same topic.

CFM Resolution No. 2436/25: Prohibits the use of anesthetic procedures in the process of tattooing, with the exception of reconstructive procedures referred by a physician.

SOCIAL PARTICIPATION

MS Public Consultation No. 2/25: Obtains contributions on the strategic version of the National “One Health” Action Plan, which aims to integrate actions for preventing, controlling, and responding to threats to human, animal, plant, and environmental health through an interinstitutional and cooperative approach.

Contribution deadline: August 22, 2025

ANVISA International Public Consultation: Invites contributions on revised documents aligned with the European Union (EU) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), focusing on the international harmonization of Good Manufacturing Practices (GMP) guidelines.

Contribution deadline: October 07, 2025

ANVISA Public Consultation No. 1338/25: Obtain contributions on the proposed normative instruction that updates IN No. 211, dated March 01, 2023, which establishes the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.

Contribution deadline: August 28, 2025

ANVISA CP No. 1339/25: Obtain contributions on the proposed normative instruction that includes the active ingredient T85 – TETRANILIPROLE in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: September 13, 2025

ANVISA CP No. 1340/25: Obtain contributions on the proposed normative instruction that includes the active ingredient A73 – 2,3,5-Triiodobenzoic Acid in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: September 28, 2025