Life Sciences and Healthcare Newsletter | May 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 approves 7 PDPs and 22 PDLs addressing rare diseases and technological innovation

On May 29, 2025, during the plenary meeting of the Executive Group of the Health Economic-Industrial Complex (“GECEIS”), the Ministry of Health (“MS”) announced the approval of 7 new projects for Productive Development Partnerships (“PDPs”) and 22 Local Development and Innovation Projects (“PDILs”). The initiative reinforces the Brazilian Federal Government’s commitment to strengthening the national production of strategic medicines and technologies for the Brazilian Unified Health System (“SUS”), with special emphasis on treating rare diseases and incorporating innovative solutions.

Among the medicines covered by the PDPs are therapies for highly complex conditions and low incidence, such as spinal muscular atrophy (SMA), cystic fibrosis, paroxysmal nocturnal hemoglobinuria (PNH), and amyloidotic polyneuropathy. The approved projects involve partnerships between public laboratories and private companies, with expected annual investments over BRL 2 billion. The PDILs include initiatives in areas such as artificial intelligence, 3D printing, diagnostic tests, medical devices, and even xenotransplantation, with total investments exceeding BRL 377 million.

Additionally, during the GECEIS plenary meeting, Minister Alexandre Padilha reported that the draft decree on the Clinical Research Law is advancing and is expected to be published before the next biannual GECEIS plenary meeting.

Proponents of rejected projects can file administrative appeals as provided for in Ordinances No. 4,472/2024 and No. 4,473/2024. The Technical Appeals Evaluation Committee will be responsible for reviewing and judging appeals.

For more information, please access the full article.

Brazilian Federal Government submits action plan to Court to regulate access to Cannabis-based medicines

On May 19, 2025, the Brazilian Federal Government, through the Brazilian Attorney General’s Office (“AGU”), filed the  Plan of Action to Regulate and Monitor Access to Cannabis-related Treatment, in compliance with a decision by  Brazil’s Superior Court of Justice (“STJ”). The measure aims to ensure safe and standardized access to Cannabis-based medicines, strictly for medicinal and scientific purposes.

The STJ’s decision was driven by the lack of comprehensive regulations governing the medical use of Cannabis in Brazil. The new regulatory framework is expected to address all stages of the production process, including seed production, cultivation (with specific safety and control regulations), processing, import and export, trade, transportation, industrialization, and inspection. Some of these stages have been partially regulated, while others remain unregulated.

The proposal, which is scheduled to be regulated by September 2025, involves coordination among several Executive Branch bodies, including the Ministries of Health, Justice and Public Security, Agriculture and Livestock, and Agrarian Development and Family Farming, as well as the Brazilian Health Regulatory Agency (ANVISA). The plan also includes consultations with specialists, patient associations, scientific institutions, and representatives from the regulated sector.

For more information, please access the full article.

CMED launches public consultation on criteria for medicine pricing and submission of Price Information Document

On April 12, 2025, the Executive Technical Committee of the Drug Market Regulation Chamber (“CTE/CMED”) published Public Consultation No. 1,330/25, aimed at gathering input on CMED Resolution No. 2, dated March 5, 2004. This resolution establishes the criteria for setting prices of new products and new presentations of medicines, as outlined in Section7 of Law No. 10,742 of October 06, 2003, and defines the procedure for submitting the Price Information Document (“DIP”).

Additionally, through a public call notice, the committee invited health professionals, patients, pharmaceutical industry representatives, researchers, government agencies, consumer protection organizations, and other interested parties to submit data, information, opinions, and suggestions regarding the publication of medicine prices in specialized media. The aim is to assess how this obligation has been implemented in practice and to understand the perspectives of numerous stakeholders regarding its usefulness and impact.

Main changes and impacts CP No. 1,330/2025 introduces:

• Restructuring of pricing categories: Introduces Category 7 (biosimilars) and Category 8 (medicines with transfer of ownership), and expands Category 3 to include medicines featuring additional innovation.
• Expansion of the list of reference countries: Includes Germany, Japan, Mexico, and the United Kingdom, and increases commercialization requirement from three to five countries – which can affect the strategy for introducing new products into the Brazilian market.
• Introduction of flat pricing: Allows for fixed pricing for different concentrations of the same medicine, provided that the treatment cost is equivalent or international prices are consistent.
• Stricter requirements for the DIP: Includes the need to demonstrate innovative activity in Brazil, which can encourage local development but also increase regulatory complexity for companies.

Contribution deadline: July 10, 2025

Interested parties can submit contributions through the electronic form available on CMED’s website.

ANVISA hosts 3rd Workshop on Biologics and Biosimilars in partnership with U.S. Pharmacopoeia and Sindusfarma

On June 24 and 25, 2025, ANVISA will host, in Brasilia, the 3rd Workshop on Biological and Biosimilar Products – a joint initiative by the U.S. Pharmacopoeia (USP) and the pharmaceutical industry association Sindusfarma. The event will gather representatives from the pharmaceutical industry, academia, and regulatory authorities to discuss the technical-scientific and regulatory advances related to these products, which have gained prominence in the global therapeutic landscape.

The agenda includes interactive technical panels, Q&A sessions, and debates on topics such as quality, safety, effectiveness, and biosimilarity. The event will also address international experiences and the practical challenges faced by the industry in adopting new regulatory approaches. The goal is to promote technical alignment among stakeholders in the sector and to strengthen Brazil’s regulatory environment.

The workshop will take place in ANVISA’s auditorium in Brasília and will offer simultaneous translation in both Portuguese and English. The on-site event is free of charge and seats are limited. Applications will remain open until June 18, 2025, or until all vacancies are filled.

Access the full agenda.

PUBLISHED REGULATIONS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA)

RDC No. 975/25: Changes Collegiate Board Resolution (“RDC”) No. 778, of March 01, 2023, which lays down the general principles, technological functions, and conditions of use for food additives and processing co-formulants.

IN No. 366/25: Provides for the inclusion of the monograph of active ingredient P76 – Pseudomonas Glycinis in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, of October 19, 2021.

IN No. 365/25: Provides for the inclusion of the monograph of active ingredient T78 – Trichoderma Viride in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, of October 19, 2021.

IN No. 364/25: Provides for the inclusion of the monograph of active ingredient F82 – Fluoxastrobin in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, of October 19, 2021.

IN No. 363/25: Provides for the inclusion of the monograph of active ingredient M47 – Melaleuca Alternifolia in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, of October 19, 2021.

IN No. 362/25: Updates the Reference Listed Drugs (“LMR”).

IN No. 361/25: Changes IN No. 28, of July 26, 2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.

NATIONAL SUPPLEMENTARY HEALTHCARE AGENCY (ANS):

RN No. 632/25: Changes Normative Resolution (“RN”) No. 465, of February 24, 2021, which provides for the List of Health Events and Procedures in Supplementary Healthcare, to:
– Update the mandatory coverage of the procedure “Outpatient Injectable Therapy (with Use Guidelines – “DUT”)”;
– Establish the mandatory coverage of the medicine Ganciclovir in post-solid organ transplants (SOT) or hematopoietic stem cell transplants (HSCT) for prophylaxis of cytomegalovirus (“CMV”) infections, or preemptive therapy of CMV infections, or treatment of CMV disease;
– Update the mandatory coverage of the procedure “Immunoprophylactic Therapy for Respiratory Syncytial Virus (RSV) (with DUT)”; and
– Establish the mandatory coverage of the medicine Nirsevimab in patients with congenital respiratory tract anomalies and/or neuromuscular disease and/or cystic fibrosis and/or immunodeficiency and/or Down Syndrome, in compliance with the provisions of paragraphs 4 and 10 of Art. 10 of Law No. 9,656/1998.

RN No. 633/25: Expressly repeals normative acts that have already been tacitly repealed, whose effects have expired, or that remain in force but whose necessity or meaning can no longer be identified, in compliance with Section63, items VIII(c), IX, and X, §§ 1 and 2; Section64; and Section67 of Decree No. 12,002/2024.

RN No. 634/25: Changes RN No. 465, of February 24, 2021, which provides for the List of Health Events and Procedures in Supplementary Healthcare, to update DUTs No. 65.9 (severe allergic asthma) and 65.10 (severe eosinophilic asthma), linked to the procedure “Intravenous, intramuscular, or subcutaneous Immunobiological Therapy (with DUT)”, in compliance with Art. 38 of RN No. 555/2022 and with the provisions of paragraph 4 of Art. 10 of Law No. 9,656/1998.

MINISTRY OF HEALTH (MS):

Provisional Measure No. 1301/25: The “Agora Tem Especialistas” program provides for Grupo Hospitalar Conceição S.A., and changes: Law No. 8,080, of September 18, 2013; Law No. 12,871, of December 22, 2012; Law No. 12,732, of June 22, 1998; Law No. 9,656, of November 03, 1994; Law No. 8,958, of October 20, 1990; and Law No. 13,958, December 19, 2019.

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

SECTICS Ordinance No. 16/25: Publishes the decision to expand the use of positron emission tomography-computed tomography (PET-CT) within the SUS for staging patients with locally advanced esophageal carcinoma that is not known to be metastatic (after inconclusive CT results).

SECTICS Ordinance No. 17/25: Publishes the decision to incorporate Methotrexate into the SUS for patients with moderate to severe atopic dermatitis, in compliance with the Clinical Protocol of the Ministry of Health.

SECTICS Ordinance No. 18/25: Publishes the decision to incorporate 0.1% Mometasone Furoate into the SUS for treating patients with atopic dermatitis, in compliance with the Clinical Protocol of the Ministry of Health.

BRAZILIAN FEDERAL MEDICINE COUNCIL (CFM):

CFM Resolution No. 2428/25: Provides for the protocol and evaluation criteria for the recognition of new medical procedures and therapies by the CFM.

CFM Resolution No. 2429/25: Regulates surgical procedures recognized by the CFM for the treatment of obesity and metabolic diseases.

CFM Resolution No. 2430/25: Provides for the expert medical act and the collection of medical-technical evidence; sets minimum safety criteria for the collection of expert evidence; updates the use of communication technologies in medical-expert examinations; and repeals CFM Resolution No. 1,497, published in the Brazilian Federal Official Gazette (“D.O.U.”)  on July 15, 1998, and CFM Resolution No. 2,325 04, published on November 04, 2022.

FEDERAL COUNCIL OF BIOMEDICINE (CFBM):

CFBM Resolution No. 395/25: Regulates the qualifications of biomedical professionals and the rules for registering with the Regional Councils of Biomedicine (“CFBM”).

SOCIAL PARTICIPATION

ANVISA CP No. 1331/25: Seeks to gather contributions on the proposed IN amendment to the List of Over-the-Counter Medicines, and publishes the list of rejected applications.

Contribution deadline: June 19, 2025

ANVISA CP No. 1332/25: Seeks to gather contributions on the proposed normative instruction that includes 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, October 19, 2021.

Contribution deadline: July 26, 2025

ANVISA CP No. 1333/25: Seeks to gather contributions on the proposed normative instruction that includes the active ingredient B73 – Betaine in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, October 19, 2021.

Contribution deadline: July 25, 2025

ANVISA CP No. 1334/25: Seeks to gather contributions on the proposed normative instruction that includes the active ingredient O23 – Ocimum Basilicum in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, October 19, 2021.

Contribution deadline: July 27, 2025

Call Notice No. 6/25: Seeks to gather public contributions on the ICH Q1 Guideline – Stability Testing of Drug Substances and Drug Products, developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Contribution deadline: June 03, 2025

Directed Consultation (GGTES) and (GGTPS): Exclusive consultation directed at the Brazilian National Health Surveillance System (SNVS), addressing proposed new regulations for the classification of medical devices as reusable or single-use, as well as the adoption of good processing practices for medical devices in healthcare settings and by healthcare service providers.