Life Sciences & Healthcare Newsletter | August 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 issues public notice for priority review of medicine applications containing Semaglutide and Liraglutide

On August 25, 2025, ANVISA published Public Notice No. 12/2025, allowing companies holding applications for registration and post-registration of medicines containing Semaglutide or Liraglutide to request priority review of their processes. The measure aims to mitigate the risk of shortages and expand access to medications indicated for type 2 diabetes and obesity, widely used as self-injectable pens.

The initiative responds to a request from the Ministry of Health, which emphasized the importance of internalizing technologies and expanding domestic production under the National Strategy for the Health Economic-Industrial Complex (“CEIS”), established by Decree No. 11,715/2023. The goal is to increase the share of domestic production of medicines, vaccines, and medical devices from 42% to 70% of the SUS’s needs.

Companies may request a priority review with applications filed up to the date of publication of the notice, provided that they have not yet been assigned for technical review. Applications must be formally submitted within 15 days through subject code 11531, in compliance with Collegiate Board Resolution (“RDC”) No. 204/2017. The Brazilian Health Regulatory Agency (“ANVISA”) will notify – within 30 days – the expected review timeline, including the projected date for technical action (requirement, approval, or denial).

Review order will follow the chronological submission of requests, with additional priority given to medicines with manufacturing steps conducted in Brazil. ANVISA’s operational capacity is limited to three synthetic and three biological applications per semester, respecting the technical and operational limits of the departments involved. Submitting a priority review request implies acceptance of the conditions established in RDC No. 204/2017, including the commercialization deadline.

For more information, access: ANVISA to prioritize approval of semaglutide and liraglutide

ANVISA publishes new regulations for sanitizing products

On August 20, 2025, ANVISA published RDC No. 989/2025 and Normative Instruction (“IN”) No. 394/2025, updating the criteria for the regularization and classification of sanitizing products based on health risk. The new regulations repeal the former RDC No. 59/2010, and aim to enhance product safety and facilitate market access within the Southern Common Market (“MERCOSUR”).

The regulatory revision began in 2019, during the 50th Meeting of MERCOSUR’s Working Subgroup (“SGT”) No. 11, held in Buenos Aires. The proposal was submitted to Public Consultation No. 776/2020 and resulted in a text aligned with the interests of the bloc’s member countries. Due to climatic and technical divergences, ANVISA opted to split the regulation: RDC No. 989/2025 incorporates the common MERCOSUR text, while IN No. 394/2025 addresses non-harmonized aspects, such as analytical tolerances and shelf life.

Among the main changes introduced by the new regulation, we highlight:

• Risk classification: Sanitizing products will be classified as risk level 1 (notification) or risk level 2 (registration), based on the oral Lethal Dose for rats (LD 50), considering the product in its undiluted form (retail sale) or at its final dilution for use (professional sale). pH values in pure state are also considered (between 2 and 11.5 for risk level 1).
• Classification by use and purpose: The regulation distinguishes products by sales condition (retail or professional) and intended use, such as general cleaning, antimicrobial action, pest control, and treatment of water for human consumption or swimming pools.
• Safety: The use of substances classified by the International Agency for Research on Cancer of the World Health Organization (“IARC”) as Group I — known human carcinogens — is prohibited, as well as substances that are mutagenic or teratogenic for mammals. These will only be tolerated as impurities, provided they are recognized as such by IARC.
• Labeling and packaging: Labeling of sanitizing products must be clear, legible, and in the official language of the country of commercialization, remaining affixed to the packaging throughout the product’s shelf life. The use of promotional phrases, unsupported claims regarding organisms or health benefits, and images that convey a false sense of safety is prohibited. Reusing packaging from food, cosmetics, medicines, or children’s products is also forbidden, as is any presentation that may mislead consumers regarding the nature or intended use of the product.
• Volume limits: Risk level 1 products may be marketed in volumes of up to 10 kg or liters. IN No. 394/2025 details limits for other categories and specific conditions, including flexible refill packaging.

For more information, access: ANVISA issues new regulations for sanitizing products.

PUBLISHED REGULATIONS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA):

RDC No. 989/25: Provides for the regularization and classification of sanitizing products, based on health risk.

RDC No. 988/25: Provides for the control of import and export of substances, plants, fungi, medicines, and products subject to special control, and other provisions.

RDC No. 987/25: Amends ANVISA RDC No. 954, dated December 20, 2024.

RDC No. 986/25: Amends ANVISA RDC No. 978, dated June 06, 2025.

IN No. 394/25: Establishes general requirements, analytical tolerances, label runoff, category list, and shelf life verification for sanitizing products, in compliance with ANVISA RDC No. 989, dated August 15, 2025.

IN No. 393/25: Amends IN No. 211, dated March 01, 2023, which sets out technological functions, maximum limits, and conditions of use for food additives and processing aids authorized for use in food.

IN No. 392/25: Provides for the inclusion of the Monograph of active ingredient B73 – Betaine in the List of Active Ingredients for Pesticides, Pest Control Sanitizers and Wood Preservatives, published through IN No. 103, dated October 19, 2021.

IN No. 391/25: Provides for the inclusion of the Monograph of active ingredient W01 – Willaertia Magna in the List of Active Ingredients for Pesticides, Pest Control Sanitizers and Wood Preservatives, published through IN No. 103, dated October 19, 2021.

NATIONAL SUPPLEMENTARY HEALTH AGENCY (ANS):

RN No. 641/25: Amends Normative Resolution (“RN”) No. 623, dated December 17, 2024, which establishes the rules to be observed by Private Health Insurance Operators and Benefit Administrators in requests for coverage of healthcare procedures or services submitted by beneficiaries, as well as non-healthcare services, under any contracting modality.

RN No. 642/25: Amends RN No. 465, dated February 24, 2021, which provides for the List of Procedures and Health Events within the scope of Supplementary Health, to expand mandatory coverage of the “Hormonal subdermal implant for contraception (with usage guidelines),” in compliance with paragraphs 4 and 10 of Article 10 of Law No. 9,656/1998.

RN No. 643/25: Amends RN No. 465, dated February 24, 2021, which provides for the List of Procedures and Health Events within the scope of Supplementary Health, to regulate mandatory coverage of the procedure “Intensity-Modulated Radiation Therapy (IMRT) for the treatment of adult patients with anal tumors,” in compliance with paragraphs 4, 7, and 8 of Article 10 of Law No. 9,656/1998.

SECRETARIAT FOR SCIENCE, TECHNOLOGY AND INNOVATION AND THE HEALTH ECONOMIC-INDUSTRIAL COMPLEX (SECTICS):

GM/MS Ordinance No. 7,676: Establishes procedures for complying with individual court decisions regarding the provision of medicines within the scope of the Ministry of Health.

SECTICS Ordinance No. 54/25: Announces the decision not to incorporate, within the scope of the Unified Health System (“SUS”), Ravulizumab for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome. Ref.: 25000.105484/2024-99.

SECTICS Ordinance No. 55/25: Announces the decision not to incorporate, within the SUS, Nivolumab for adjuvant treatment of adult patients with confirmed diagnosis of esophageal carcinoma following trimodal therapy (chemotherapy, radiotherapy, and surgery). Ref.: 25000.172673/2024-77.

SECTICS Ordinance No. 56/25: Announces the decision to incorporate, within the SUS, the device for percutaneous closure of patent ductus arteriosus using a cardiovascular implant in the form of an expandable nitinol mesh plug, for the treatment of premature newborns or those with low birth weight. Ref.: 25000.149233/2024-16.

SECTICS Ordinance No. 57/25: Announces the decision not to incorporate, within the SUS, Nivolumab and Pembrolizumab for first-line treatment of advanced or metastatic esophageal carcinoma in patients with high PD-L1 expression. Ref.: 25000.172681/2024-13.

SECTICS Ordinance No. 59/25: Announces the decision to approve, within the scope of the SUS, the Clinical Protocol and Therapeutic Guidelines for Scorpion Envenomation.

SECTICS Ordinance No. 62/25: Announces the decision not to incorporate, within the SUS, Delandistrogene Moxeparvovec for ambulatory patients aged 4 to 7 years diagnosed with Duchenne muscular dystrophy. Ref.: 25000.006305/202512.

SECTICS Ordinance No. 63/25: Announces the decision not to incorporate, within the SUS, Lumasiran for the treatment of primary hyperoxaluria type 1.

SOCIAL PARTICIPATION

ANVISA Public Consultation No. 1342/25: Proposal for a normative act concerning the general method texts for determining residual formaldehyde and the monographs of hyperimmune sera for human use, yellow fever vaccine (attenuated), rabies vaccine (inactivated), and vaccines for human use.
Deadline for contributions: October 02, 2025

ANVISA Public Consultation No. 1343/25: Open to receive contributions on the proposal for a normative act regarding Text 4 – Generalities of the Brazilian Pharmacopoeia.
Deadline for contributions: October 06, 2025

ANVISA Public Consultation No. 1344/25: Open to receive contributions on the proposed revision of RDC No. 722, dated July 1, 2022, which establishes the maximum tolerated limits (“MTLs”) of contaminants in food, the general principles for their establishment, and the analytical methods for conformity assessment.
Deadline for contributions: October 24, 2025

ANVISA Public Consultation No. 1345/25: Open to receive contributions on the proposed revision of IN No. 160, dated July 01, 2022, which sets the MTLs of contaminants in food.
Deadline for contributions: October 24, 2025

ANVISA Public Consultation No. 1346/25: Open to receive contributions on the proposed revision of general methods 5.1.2 Volume determination, 5.2.10 Residue by incineration (sulfated ash), 5.2.11 Particle size determination of powders, 5.2.22.1 Capillary electrophoresis, 5.3.3.1 Titrations, and 5.5.2.7.3 Bacterial endotoxin test.
Deadline for contributions: October 27, 2025

ANVISA Public Consultation No. 1347/25: Open to receive contributions on the proposed RDC establishing criteria, requirements, and procedures for laboratories that perform tests and technical analyses on products and services subject to sanitary surveillance, and other provisions.
Deadline for contributions: October 27, 2025