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Life Sciences and Healthcare Newsletter | January 2025
February 13th, 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.
Outlook on ANVISA’s activities in 2025
Aiming to keep our clients informed about the current regulatory landscape in Life Sciences and Healthcare, we have prepared a client alert based on the updated regulatory agenda (“AR”) published by the Brazilian Health Regulatory Agency (“ANVISA”), to provide information on important matters that may progress throughout 2025.
See below the content addressing pesticides, foods, cosmetics, medicines, medical devices, health services, ports, airports and borders, and other topics.
Find out more: Outlook on ANVISA’s activities in 2025 – Demarest
ANVISA holds public hearing on review of regulatory framework for herbal medicines
The proposed regulatory framework seeks to modernize the criteria and controls for herbal medicines, foster the development of the Brazilian industry, and improve patient access to safe and effective products.
The review of the regulatory framework for herbal medicines is addressed in the following CPs:
- CP No. 1290/24, which is available for contributions until March 05, 2025, and proposes a Collegiate Board Resolution (“RDC”) on the marketing authorization of herbal medicines as well as the marketing authorization and notification of traditional herbal products.
- CP No. 1291/24, which is available for contributions until March 05, 2025, and proposes a normative instruction (“IN”) on prohibitions and restrictions applicable to the composition of herbal medicines.
- CP No. 1292/24, which is available for contributions until March 05, 2025, and proposes an IN on the “list of agrochemicals selected for analysis in herbal medicines”.
- CP No. 1293/24, available for contributions until March 11, 2025, and proposes the revision of IN No. 02/14, which published the “List of herbal medicines for simplified marketing authorization” and the “List of traditional herbal products for simplified marketing authorization”.
The public hearing was held on February 06, 2025, from 8.30am to 12pm, in ANVISA’s auditorium in Brasília/DF. Prior registration was not required.
Find out more: ANVISA holds public hearing on herbal medicines – ANVISA (Portuguese only)
ANVISA postpones entry into force of Resolution on simplified marketing authorization procedures
On January 20, 2025, ANVISA published Resolution RDC No. 960/25, postponing the entry into force of RDC No. 954/24, which establishes the criteria for marketing authorizations (“MA”), post-approval changes, and simplified renewal procedures for generic, similar, specific, dynamized, herbal, radiopharmaceutical, and biological products.
Within this context, RDC No. 954/24 will come into effect on March 25, 2025. In turn, the possibility of ANVISA requesting a complete or partial dossier will come into force on June 22, 2025.
ANS opens public consultation to improve oversight model in Brazil
The Brazilian Supplementary Healthcare Agency’s (“ANS”) initiative seeks to improve the current oversight model, which mainly relies on individual analyses of demands between beneficiaries and operators through the Notice of Preliminary Intermediation (“NIP”). The constant increase in NIPs raised a red flag for ANS regarding its inefficiency in enforcing coercive measures and sanctions against violations.
Interested parties may submit their contributions by March 07, 2025, through the ANS portal.
The proposal adopted by the ANS seeks to develop a hybrid oversight model, in which individual inspection through NIPs will be maintained, but complemented by strategic actions collectively. In addition, the proposal seeks to increase fine amounts in the event of infractions.
BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA):
RDC Nº 958/25: Provides for the update of Annex I (“Lists of Narcotic, Psychotropic, Precursory, and Other Substances under Special Control”) provided for by Ordinance No. 344 of May 12, 1998, of the Health Surveillance Secretariat of the Ministry of Health (“SVS/MS”).
RDC Nº 959/25: Amends RDC No. 585/21, which approves and enacts ANVISA’s internal regulations.
RDC Nº 960/25: Postpones the entry into force of RDC No. 954/24, which provides for the simplified procedure regulating applications for medicines registration, post-registration, and renewal, and other provisions.
BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY:
Normative Ordinance No. 2/25: Provides for establishing the Innovation Laboratory of the National Audit Department of the Unified Health System (“DenaSUS”).
GM/MS Ordinance No. 6552/25 Provides for establishing the Innovation Laboratory of the National Audit Department of the Unified Health System (“DenaSUS”).
GM/MS Ordinance No. 6531/25: Establishes the Public Health Emergency Operations Center for Dengue and other Arboviruses, within the scope of the MS.
GM/MS Ordinance No. 6581/25: Amends provisions of Chapter IV-A of Title VI of the Minister’s Office Consolidation Ordinance – GM/MS No. 5, of September 28, 2017, to change the organization and structure of the National Precision Genomics and Public Health Program (Genomas Brasil), and establish the Program’s Technical Advisory Board.
GM/CNS Ordinance No. 738/25: Provides for the use of databases to carry out scientific research involving human beings.
FEDERAL NURSING COUNCIL (“COFEN”):
COFEN Resolution No. 773/25: Regulates the creation of subsections and/or administrative offices by the Regional Nursing Councils, and provides other measures.
Call Notice No. 01/25: Convenes healthcare service companies that perform bedside hemodialysis (specialized intervention aimed at treating chronic kidney disease patients admitted to intensive care units – ICUs – or clinical wards) to participate in a national survey regarding the condition of bedside dialysis in Brazil. Deadline for contribution: February 23, 2025
Public hearing on review of regulatory framework for herbal medicines: The public hearing took place on February 06, 2025, from 8:30 a.m. to 12 p.m., in ANVISA’s auditorium in Brasília/DF. No prior registration was required, and participants were accepted subject to the auditorium’s capacity.
ANVISA CP No. 1306/25: Receive contributions on the proposed IN that includes the active ingredient F82 – Fluoxastrobin in the “List of Active Ingredients of Pesticides, Sanitizing Disinfectants, and Wood Preservative Products”, published by IN No. 103, of October 19, 2021. Deadline for contribution: April 01, 2025
ANVISA CP No. 1307/25: Receive contributions on the proposed IN that includes sub-item M47.2 – Melaleuca Alternifolia Extract in monograph M47 – Melaleuca Alternifolia, in the “List of Active Ingredients of Pesticides, Sanitizing Disinfectants and Wood Preservative Products”, published by IN No. 103, of October 19, 2021. Deadline for contribution: April 01, 2025
ANVISA CP No. 1308/25: Receive contributions on the proposed IN that includes the active ingredient P76 – Pseudomonas Glycinis in the “List of Active Ingredients of Pesticides, Sanitizing Disinfectants and Wood Preservative Products”, published by IN No. 103, of October 19, 2021. Deadline for contribution: April 01, 2025
ANVISA CP No. 1309/25: Receive contributions on the IN proposal that updates information regarding items 1 and 3 of the monograph of the active ingredient T78 – Trichoderma Viride, in the “List of Active Ingredients of Pesticides, Sanitizing Disinfectants and Wood Preservative Products”, published by IN No. 103, of October 19, 2021. Deadline for contribution: April 01, 2025
ANS CP No. 148/24: Receive contributions on the update of the Usage Guidelines (“DUT”) relating to the treatment of severe uncontrolled asthma – current DUTs 65.9 (severe eosinophilic asthma) and 65.10 (severe allergic asthma) – integrating Annex II of Normative Resolution (“RN”) No. 465/2021, connected to the procedure of “intravenous, intramuscular or subcutaneous immunobiological therapy (including guidelines for use)”, addressed in Technical Analysis Unit (“UAT”) No. 128, to update the List of Procedures and Events in Supplementary Health of the preliminary recommendation for incorporating the technology provided for by UAT No. 141 – Bimequizumab. Deadline for contribution: February 10, 2025
Secretariat of Science, Technology, and Innovation, and Health Economic-Industrial Complex (“SECTICS”) CP No. 1/25: Receive contributions on Satralizumab to treat patients with optic neuromyelitis spectrum disorder. Deadline for contribution: February 04, 2025
SECTICS CP No. 2/25: Receive contributions on Ramucirumab as monotherapy or associated with Paclitaxel, 2nd line treatment of patients with advanced or metastatic gastric or gastroesophageal junction cancer. Deadline for contribution: February 04, 2025
SECTICS CP No. 3/25: Receive contributions on Trastuzumab to treat adults with stomach or esophageal junction cancer, advanced or metastatic, HER2+, not previously treated (1st line). Deadline for contribution: February 04, 2025
SECTICS CP No. 4/25: Receive contributions on Burosumab to treat X-chromosome-linked hypophosphatemia in adults. Deadline for contribution: February 04, 2025
SECTICS CP No. 5/25: Receive contributions on Zirconium Sodium Cyclosilicate to treat severe hyperkalemia in patients with chronic kidney disease. Deadline for contribution: February 04, 2025
SECTICS CP No. 6/25: Receive contributions on Nivolumab to treat adults with stomach or esophageal junction cancer, advanced or metastatic, not previously treated. Deadline for contribution: February 04, 2025
SECTICS CP No. 7/25: Receive contributions on contact force catheter for radiofrequency ablation and electroanatomic mapping in adult patients with complex cardiac arrhythmias. Deadline for contribution: February 04, 2025
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