Life Sciences and Healthcare Newsletter | February 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

CMED opens targeted consultation on the pricing of advanced therapy products

On February 07, 2025, the Drug Market Regulation Chamber (“CMED”) published Notice No. 1/25 to receive contributions on the pricing criteria for advanced therapy medicinal products (“ATMPs”) (“Targeted Consultation”).

ATMPs are an innovative class of biological medicines for treating complex conditions, rare diseases, or those without available medical alternatives, such as multiple myeloma, acute lymphoblastic leukemia, hereditary retinal dystrophy, among others.

The initiative seeks to address the regulatory gap of CMED Resolution No. 2, of March 05, 2004, which does not cover new ATMP technologies within the regulated categories established, resulting in the categorization of these products as omitted cases, thus requiring the establishment of criteria for the pricing of the ATMPs.

Interested parties can submit their contributions through the portal (Portuguese only) until March 28, 2025.

For more information: https://www.demarest.com.br/en/cmed-opens-targeted-consultation-on-pricing-of-advanced-therapy-products/

ANVISA updates requirements for forced degradation studies and impurity parameters in synthetic and semi-synthetic medicines

On February 24, 2025, the Brazilian Health Regulatory Agency (“ANVISA”) published Collegiate Board Resolution (“RDC”) No. 964/25, which establishes the general requirements for conducting forced degradation studies (stress testing) in medicines containing synthetic and semi-synthetic active pharmaceutical ingredients (APIs).

The resolution, which was subject to a Regulatory Impact Analysis (RIA) published in July 2023, seeks to:

• Improve the wording and technical content of the regulation;
• Update concepts and definitions;
• Reduce the number of studies required for impurity qualification; and
• Align the criteria for conducting forced degradation studies with the international guidelines on the subject, such as the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The RDC came into effect on February 24, 2025. Until February 24, 2027, companies can submit studies that comply with RDC No. 53/15, which will be accepted by ANVISA.

For more information: https://www.demarest.com.br/en/anvisa-atualiza-requisitos-para-estudos-de-degradacao-forcada-e-parametros-de-impurezas-em-medicamentos-sinteticos-e-semissinteticos/

ANVISA establishes optimized analysis procedure for the food industry

On February 21, 2025, the ANVISA published Normative Instruction (“IN”) No. 344/25, which establishes the optimized analysis procedure for the food industry by using assessments issued by a foreign equivalent regulatory authority (“AREE”).

This optimized procedure is essential to streamline the regularization process of new products in Brazil, allowing innovations to be implemented into the national market as swiftly as possible. By using the assessments of an AREE, ANVISA improves its responsiveness to the demands of the regulated sector, thus saving resources and time.

IN No. 344/25 enters into force on March 23, 2025. Simplified petitions filed before March 23, 2025, that do not comply with this IN can be subject to technical requirements for submitting further mandatory documents, as established by IN No. 344/25.

For more information: https://www.demarest.com.br/en/anvisa-establishes-optimized-analysis-procedure-for-the-food-industry/

CEIS, PDPs, and PDILs: Federal Government announces innovative projects to strengthen the national industry

On February 25, 2025, the Federal Government announced innovative projects aimed at strengthening the national industry. The highlights include the production of a 100% national, single-dose vaccine against dengue, as well as partnerships for the local production of insulin, a vaccine against avian flu, and a vaccine against Respiratory Syncytial Virus (RSV).

These initiatives are part of the Local Development and Innovation Program (“PDIL”) and the Partnership for Productive Development (“PDP”), which aim to foster the local production of medicines and health technologies. They are coordinated by the Ministry of Health (“MS”) through the Health Economic-Industrial Complex (“CEIS”).

For more information: https://www.gov.br/saude/pt-br/assuntos/noticias/2025/fevereiro/governo-federal-anuncia-primeira-vacina-100-nacional-e-de-dose-unica-contra-a-dengue (Portuguese only)

ANS establishes deadlines and risk rating for its public release acts

On February 14, 2025, the Brazilian Supplementary Healthcare Agency (“ANS”) published Normative Resolution (“RN”) No. 626/25, which provides for the risk rating and public release acts for the economic activities within the scope of ANS regulation, in compliance with Law No. 13,874/19, establishing the Declaration of Economic Freedom Rights, and its regulatory decree, Decree No. 10,178/19.

Public release acts are all acts issued by a public authority as a condition for carrying out an economic activity, as established by Decree No. 10,178/19, which includes licenses, authorizations, concessions, registrations, permits, approvals, among others.

In this regard, RN No. 626/25 establishes the 23 public acts under the ANS’s competence, as well as their respective risk levels and approval deadlines. If the ANS does not issue a statement within the corresponding deadline, tacit approval will be considered.

For more information: https://www.demarest.com.br/en/ans-establishes-deadlines-and-risk-classification-for-its-public-release-instruments/

PUBLISHED NORMATIVE ACTS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA):

RDC No. 961/25: Changes RDC No. 56/12, which provides for the positive list of monomers, other starting substances and polymers authorized to produce plastic packaging and equipment in contact with food.

RDC No. 962/25: Changes RDC No. 585/21, which approves and enacts ANVISA’s Internal Regulations.

IN No. 343/25: Updates the list of Brazilian Common Denominations (“DCB”).

RDC No. 963/25: Changes RDC No. 326/19, which establishes the positive list of additives intended for producing plastic materials and polymer coatings in contact with food.

RDC No. 964/25: Establishes the general requirements for conducting Forced Degradation Studies on medicines containing synthetic and semi-synthetic active pharmaceutical ingredients, and further defines the parameters for notifying, identifying, and qualifying degradation products in these same products.

IN No. 344/25: Establishes the conditions for an optimized procedure to analyze petitions for assessing the food industry by accepting instructional documentation issued by an AREE.

IN No. 345/25: Changes IN No. 338/24, which establishes, in compliance with RDC No. 945/24, the list of AREEs and further details the criteria for adopting the optimized analysis procedure via reliance and risk and complexity assessment of requests for Drug Clinical Development Dossier (“DDCM”), Specific Clinical Trial Dossier (“DEEC”), substantial changes to the product under investigation and significant amendments to the clinical protocol.

RDC No. 965/25: Changes RDC No. 951 of December 13, 2024.

BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY:

RN No. 626/25: Provides for the risk rating and public acts of release of economic activity within the scope of the regulation of the National Supplementary Health Agency addressed by Decree No. 10,178, of February 18, 2019.

RN No. 627/25: Changes RN No. 465, of February 24, 2021, which provides for the List of Health Procedures and Events within the scope of Supplementary Health, to update the mandatory coverage of the procedure “Outpatient Injectable Drug Therapy (with usage guidelines)”, to establish the mandatory coverage of Romiplostim for treating adult individuals with refractory or corticosteroid-dependent, primary, idiopathic, thrombocytopenic purpura; to regulate the mandatory coverage of the procedure “Infectious Agents in Encephalitis and Meningitis – Multiplex Panel PCR Detection in Cerebrospinal Fluid” for detecting multiple bacterial, viral, and fungal agents causing meningitis and encephalitis; to include in the List of Health Procedures and Events the term “Installation and Maintenance of Left Ventricular Assist Device (LVAD) by Thoracotomy (with usage guidelines)”, in compliance with the provisions of paragraphs 4 and 10, of Art. 10 of Law No. 9,656/1998.

MINISTRY OF HEALTH (“MS”):

GM/MS Ordinance No. 6590/25: Changes GM/MS Consolidation Ordinance No. 2, of September 28, 2017, to regulate the National Cancer Prevention and Control Policy (“PNPCC”), within the scope of the Brazilian Unified Health System (“SUS”).

GM/MS Ordinance No. 6591/25: Changes GM/MS Consolidation Ordinance No. 3, of September 28, 2017, and establishes, within the scope of the PNPCC Policy, the Cancer Prevention and Control Network (“RPCC”).

GM/MS Ordinance No. 6592/25: Changes Consolidation Ordinance No. 5, of September 28, 2017, to establish the  Brazilian Program for Diagnosed Cancer Patient Navigation, within the scope of the SUS.

GM/MS Ordinance No. 6613/25: Changes Exhibit LXXVII of GM/MS Consolidation Ordinance No. 5, of September 28, 2017, to establish cost-free medicines included in the list of “Farmácia Popular” to treat urinary incontinence and diabetes mellitus associated with cardiovascular disease, thus extinguishing the co-payment modality of the program.

GM/MS Ordinance No. 6609/25: Changes the attributes of procedures in the SUS Table of Procedures, Medicines, Orthoses, Prostheses, and Special Materials, among other measures.

GM/MS Ordinance No. 6604/25: Establishes the Technical Support Group for Racial Equity in Healthcare (“GATER”), within the scope of the MS.

GM/MS Ordinance No. 6623/25: Establishes the Immunobiological Network for People in Special Situations (“RIE”).

CNS Resolution No. 767/24: Provides for the approval of the National Cancer Prevention and Control Policy within the scope of the SUS, as well as the Brazilian Program for Diagnosed Cancer Patient Navigation.

DRUG MARKET REGULATION CHAMBER (“CMED”)

Ordinance No. 1/25: Updates the list of economic groups, in compliance with the regulations addressed by CMED Notification No. 5, of March 25, 2015, to define the market concentration index by therapeutic class in order to establish the three levels of the intra-sector relative price adjustment factor (Z-Factor), to be used in the 2025 medication price adjustment.

FEDERAL COUNCIL OF BIOLOGY (“CFBIO”):

CFBIO Resolution No. 724/25: Provides for the registration of legal entities, cancellations, Technical Responsibility Certificates (TRT), and endorsement of Technical Capacity Certificates.

SOCIAL PARTICIPATION

Call Notice No. 02/25: Seeks to receive contributions on ICH E6 (R3) guide – Annex 2 – Good Clinical Practice (GCP) Guide for subsequent consolidation by the Expert Working Group (EWG) and timely submission to the ICH. Contribution period deadline: March 14, 2025

ANVISA CP No. 1311/25: Seeks to receive contributions on the proposed IN seeking to amend IN No. 160, of July 01, 2022, which establishes the maximum tolerated limits (“MRLs”) for food contaminants, in compliance with the corresponding Annex. Contribution period deadline: April 20, 2025

ANVISA CP No. 1310/25: Seeks to receive contributions on the proposed change in the monographs integrating the List of Active Ingredients of Pesticides, Sanitizing Disinfectants, and Wood Preservatives, published through IN No. 103, of October 19, 2021. Contribution period deadline: April 21, 2025

ANVISA CP No. 1312/25: Seeks to receive contributions on the proposed IN seeking to include the active ingredient O22 – Ooencyrtus Submetallicus in the List of Active Ingredients of Pesticides, Sanitizing Disinfectants, and Wood Preservatives, published through IN No. 103, of October 19, 2021. Contribution period deadline: May 01, 2025

Call Notice No. 03/25: Seeks to extend the effectiveness of Public Call Notice No. 01/2025, initially scheduled within 30 days, for another 15 days, from February 23, 2025, seeking to allow as many hospital service providers as possible to respond to the Brazilian National Survey regarding bedside dialysis in Brazil. Contribution period deadline: March 09, 2025

ANVISA Targeted Consultation No. 1/25: Seeks to receive contributions on the current procedure for registering Borderline Products with ANVISA, in compliance with item 1.25 of ANVISA’s 2024-2025 Regulatory Agenda. Contributions can be submitted through ANVISA’s portal.

ANS CP No. 145/25: Seeks to receive contributions on the Price and Adjustment Policy, addressed by CP No. 145, of December 17, 2024, published in Brazilian Federal Official Gazette (“DOU”) No. 244, of December 19, 2024, Section One, page 289, in compliance with RN No. 548, of October 10, 2022. Contribution period deadline:  February 09, 2025

ANS CP No. 149/25: Seeks to receive contributions on the preliminary recommendation not to incorporate the technologies contained in Adult Transitional Reception Unit (“TAU”) No. 147 – Selpercatinib and TAU No. 148 – Ivosidenib. Contribution period deadline: February 25, 2025

ANS CP No. 150/25: Seeks to receive contributions on the proposed RN for creating the Internal Regulations of the Commission for Updating the List of Procedures and Events in Supplementary Health (“COSAÚDE”), in compliance with RN No. 548, of October 10, 2022. Contribution period deadline: March 27, 2025

ANS CP No. 151/25: Seeks to receive contributions on the regulations for incorporating and operating an experimental regulatory environment (Regulatory Sandbox), called “Plan for strictly elective medical consultations and exams”. Contribution period deadline: April 04, 2025