The Life Sciences and Healthcare Newsletter brings information and news about key issues related to the Brazilian life sciences and healthcare sector and recent legislation. This initiative covers transactional and regulatory industry issues and invites all market players to access relevant news from the sector and comments on such topics.
Please read and enjoy!
DeMarest's Life Sciences and Healthcare Team
This material is for useful 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 an announcement for priority review of medical applications containing semaglutide and liraglutide
On August 25, 2025, ANVISA issued Notice No. 12/2025, allowing companies holding registration and post-registration applications for drugs containing semaglutide or liraglutide to request a process priority review. The measures aim to reduce the risk of shortages and increase access to medications shown for type 2 diabetes and obesity.
This initiative will respond to requests from the Ministry of Health. This under the national strategy of the Health Economy and Industrial Complex (“CEIS”), established by Order No. 11,715/2023, internalized technology and emphasized the importance of expanding domestic production. The goal is to increase the share of domestic production of medicines, vaccines and medical devices from 42% to 70% of SUS needs.
Companies may request a priority review on applications submitted by the date of publication of the notice, if they have not been assigned for technical reviews yet. The application is a resolution of the university's board of directors (“RDC”) No. In accordance with 204/2017, it must be officially submitted within 15 days through Subject Code 11531. The Brazilian Health Regulatory Authority (“ANVISA”) will be notified within 30 days.
Review orders are given additional priorities to drugs with manufacturing procedures carried out in Brazil and follow the chronological submission of requests. Anvisa's operational capabilities are limited to three synthesis and three biological applications per semester, respecting the technical and operational limits of the departments involved. Submitting a priority review request means acceptance of the terms established in RDC No. 204/2017, including the commercialization deadline.
For more information, visit: ANVISA preferring approvals for Semaglutide and Liraglutide
Anvisa has published new regulations for disinfecting products
On August 20, 2025, ANVISA received RDC No. 989/2025 and normative guidance (“In”) No. We announced 394/2025 to update the standard for normalising and classifying disinfectant products based on health risks. The new regulations aim to eliminate the previous RDC No. 59/2010, increasing product safety and promote market access within the Southern Common Market (“Mercosur”).
The revision of the regulations was made in the No. of Mercosur working subgroup (“SGT”) held in Buenos Aires. It began in 2019 during the 50th meeting of the 11th. The proposal was submitted in Public Consultation No. 776/2020 and brought text consistent with the interests of the bloc's member states. Due to climate and technical differences, Anvisa chose to split the regulations. RDC No.989/2025 incorporates the general Mercosur text, but no. 394/2025 addresses non-standardized aspects such as analytical tolerances and shelf life.
Among the major changes introduced by the new regulations, we highlight:
Risk Classification: Sanitized products are classified as risk level 1 (notice) or risk level 2 (registration) and consider undiluted form (retail sale) or final dilution of use (professional sale) based on the oral lethal dose of rats (LD 50). Pure state pH values are also considered (between 2 and 11.5 for risk level 1).
Classification by Use and Purpose: Regulations distinguish products by terms of sale (retail or professional) and purpose use, including general cleaning, antibiotic effects, pest control, and water treatment for human consumption or swimming pools.
Safety: Use of substances classified by the International World Health Organization's Research Office (“IARC”) – known human carcinogens – and mammalian mutagenic or teratogenic substances are prohibited. These are only accepted as impurities if they are so recognized by the IARC.
Labeling and packaging: Labeling of disinfectant products must be clear and easy to read, and in the official language of commercialization, it must remain on packaging for the entire shelf life of the product. The use of promotional phrases, unsupported claims about biological and health benefits, and images that convey false sense of safety are prohibited. Reuse of packaging from food, cosmetics, medicines or children's products is also prohibited. This is similar to presentations that can mislead consumers about the nature of the product and intended use.
Volume Limit: Risk Level 1 Products may be sold in volumes up to 10 kg or liters. No. 394/2025 has detailed restrictions on other categories and certain conditions, including flexible refill packages.
For more information, access: ANVISA issuing new regulations for disinfecting products.
Published regulations
Brazilian Health Regulatory Agency (ANVISA):
RDC No. 989/25: Regulations the regularization and classification of sanitized products of products based on health risks.
RDC No. 988/25: provides for the control of import and export of substances, plants, fungi, medicines and products subject to special control.
RDC No. 987/25: Corrected ANVISA RDC No. 954 dated December 20, 2024.
RDC No. 986/25: Corrected ANVISA RDC No. 978 dated June 6, 2025.
On No. 394/25: Establish validation of general requirements, analytical resistance, label spills, category listings, and shelf life in accordance with ANVISA RDC No. 989 dated August 15, 2025.
No. 393/25: revised number 211 dated March 1, 2023. It sets the technical features, maximum limits and terms of use of food additives, and processes aids permitted for use in food.
No. 392/25 provides for the inclusion of monographs of active ingredient B73 in the list of active ingredients for pesticides, pest control inhibitors, and wood preservatives listed in No. 103 dated October 19, 2021.
No. 391/25 stipulates that the monograph of Active Ingredients W01 – Willaertia Magna will be included in the list of active ingredients for pesticides, pest control defenses and wood preservatives listed in No. 103 dated October 19, 2021.
National Supplementary Health Organization (ANS):
RN No. 641/25: Norm resolution dated December 17, 2024 (“RN”) No. Fix 623. This establishes rules that private health insurance operators adhere to and establishes benefits for managers within the scope of medical procedures or services submitted by the beneficiary.
RN No. 642/25: Corrected RN No. 465 dated February 24, 2021. It provides a list of procedures and health events within the supplemental health scope, expanding the mandatory coverage of “hormonal subdelmal implants for contraception (using usage guidelines)” and complies with Article 4, Article 10 and Article 10 of 1998.
RN No. 643/25: Corrected RN No. 465 dated February 24, 2021. This provides a list of procedures and health events within the supplemental health scope and regulates mandatory coverage of procedures.
Secretariat of Science, Technology, Innovation and Health Economics and Industrial Complex (Denomination):
GM/MS Ordinance No. 7,676: Establish procedures to comply with individual court decisions regarding the provision of medicines within the Ministry of Health.
SECTICS Ordinance No. 54/25: Announces decisions not to be incorporated within the scope of a unified healthcare system (“SUS”) and within the scope of a loburizumab for the treatment of adults and pediatric patients with atypical hemolytic uremic syndrome. Ref. :25000.105484/2024-99.
SECTICS Ordinance No. 55/25: Announces within SUS the decision not to incorporate Nivolumab for adjuvant treatment in confirmed adult patients with esophageal cancer following tomodal therapy (chemotherapy, radiation therapy, and surgery). Ref. :25000.172673/2024-77.
SECTICS Ordinance No. 56/25: Announces the decision within SUS to incorporate a device for percutaneous closure of patented intraductal arteries using cardiovascular implants in the form of extensible nitinol mesh plugs for the treatment of preterm birthable neonates or low birth weights. Ref. :25000.149233/2024-16.
SECTICS Ordinance No. 57/25: Announces decision not to be incorporated into SUS for first-line treatment of advanced or metastatic esophageal cancer in patients with high PD-L1 expression. Ref. :25000.172681/2024-13.
SECTICS Ordinance No. 59/25: Announces decision to approve Scorpion Envenomation's clinical protocols and treatment guidelines within the scope of SUS.
SECTICS Ordinance No. 62/25: Announces a decision not to incorporate DelandiStrogene Moxeparvovec in SUS of outpatients aged 4-7 years old diagnosed with Duchenne muscular dystrophy. Ref. :25000.006305/202512.
SECTICS Ordinance No. 63/25: Announces a decision within SUS that will not incorporate Lumasiran for the treatment of primary oxiduria type 1.
Social participation
Anvisa Public Consultation No. 1342/25: General Methods for Determining Residual Formaldehyde Text and Proposal of Normative Actions for Determining Hyperimmune Serum Monographs for Human Use, Yellow Fever Vaccines (Antique), Rabies Vaccines (Inactivation), and Vaccines for Human Use.
Donation deadline: October 2, 2025
Anvisa Public Consultation No. 1343/25: You can receive contributions on proposals for normative conduct in text 4 – Generality of the Brazilian Pharmacopoeia.
Donation deadline: October 6, 2025
Anvisa Public Consultation No. 1344/25: You will receive contributions in relation to the proposed revision of RDC No. 722 dated July 1, 2022.
Donation deadline: October 24, 2025
Anvisa Public Consultation No. 1345/25: Following contributions to the proposed revision of issue 160 dated July 1, 2022, we will set the MTL for contaminants in food.
Donation deadline: October 24, 2025
Anvisa Public Consultation No. 1346/25: Proposed Revision of General Methods 5.1.2 Volume Measurements, 5.2.10 Residue (sulfide ash), 5.2.11 Particle Size Measurements, 5.2.22.1 Capillary Electrophoresis, 5.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.3.
Donation deadline: October 27, 2025
Anvisa Public Consultation No. 1347/25: Following the proposed RDC contributions, establish the standards, requirements and procedures for the laboratory that conducts testing and technical analysis of products and services subject to hygiene monitoring.
Donation deadline: October 27, 2025
