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In Focus

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Client Alert

04/02/2026

Regulatory Trends for the Life Sciences Sector in 2026: 17 Key Topics for Companies Regulated by Anvisa, ANS, and MAPA

As 2026 begins, companies regulated by Brazilian Health Regulatory Agency (Anvisa), the National Supplementary Health Agency (ANS), and the Ministry of Agriculture and Livestock (MAPA) face a dynamic regulatory landscape. To support organizations in anticipating risks and preparing for strategic decision‑making, our Life Sciences & Healthcare team has identified 17 regulatory topics that will shape …
Client Alert

08/01/2026

Healthcare Judicialization: CMED opens Public Consultation on pricing rules for Government purchases

On January 8, 2026, the Brazilian Drug Market Regulation Chamber (CMED) published in the Federal Register the Public Consultation No. 1/2026, which aims to gather contributions from civil society and the regulated sector on criteria for setting and adjusting prices of medicines sold to government entities to comply with court-ordered demands. The regulation of this …
Client Alert

29/12/2025

CMED publishes new regulatory framework for pricing medicines in Brazil

On December 24, 2025, the Brazilian Drug Market Regulation Chamber (“CMED”) published Resolution 3/2025 in the Federal Register, establishing criteria for the definition of prices for new products and new presentations of medicines, as provided in Article 7 of Law 10,742/2003, and setting out the procedure for filing the Price Information Document (“DIP”). Resolution 3/2025was …
Client Alert

19/12/2025

Law No. 15,270/2025 Published – Taxation of Dividends

Law No. 15.270/2025, resulting from the approval of Bill No. 1.087, was published on November 27, 2025. The main provisions of the Law, which will take effect as of January 1, 2026, are as follows: Dividend Taxation and High-Income Taxation: Taxation of dividends received by individuals residing in Brazil at a 10% rate, when the …
Client Alert

12/12/2025

Law 15,040/2024: What Changes Under the New Insurance Legal Framework

This week, Law No. 15,040/2024, known as the “Insurance Legal Framework,” came into effect, establishing a specific legal regime for insurance contracts in Brazil. The new law aims to modernize rules, consolidate interpretations, and enhance legal certainty in relationships between insurers and policyholders. Although public debate has focused on the impacts for insurers, the new …
Client Alert

09/12/2025

Publication of the Ordinance establishing INAEP and defining its coordination

On December 4, 2025, Ordinance GM/MS No. 1,283 was published, appointing full and alternate members to compose the National Authority for Research Ethics (INAEP), a collegiate body regulated by Decree No. 12,651/2025 within the National System of Research Ethics Involving Human Subjects. INAEP will be coordinated by Dr. Meiruze Sousa Freitas, currently director of the …
Client Alert

02/12/2025

Deadline Alert – Annual Compliance Report to SPA/MF – Only two months left

As the end of the year approaches, please note that there are only two months left to submit the Annual Anti-Money Laundering and Counter-Terrorism Financing (AML/CFT) Compliance Report to the Secretariat of Prizes and Betting (SPA/MF), as established in Article 11 of SPA/MF Ordinance No. 1,143 (February 1, 2026). Considering the complexity and volume of …
Client Alert

25/11/2025

Brazil advances in regulatory transition for clinical research

Publication of Technical Note No. 43/2025 – Department of Science and Technology (“DECIT”) / Secretariat of Science, Technology, and Innovation in Health (“SECTICS”) / Ministry of Health (“MS”) The Ministry of Health has published Technical Note No. 43/2025, providing guidance for the processing and risk classification of research involving human subjects within the National System …
News

22/10/2025

Souto Correa Recognized as Best Legal Team in Media & Entertainment at BRALLAW 2025

On the evening of October 16, Souto Correa Advogados was honored as the Best Legal Team in the Media & Entertainment sector during the 5th edition of the Brazil’s Leading Lawyers Awards (BRALLAW), organized by Leaders League Brasil. This recognition celebrates the technical excellence and dedication of our Media & Entertainment team, composed of Leticia …
Client Alert

09/10/2025

Regulation of the Clinical Research Law and next steps

On October 8, 2025, Decree No. 12,651/2025 came into force, regulating Law No. 14,874/2024 and establishing the National System of Ethics in Research with Human Subjects (SNEP). The regulation consolidates guidelines for ethical approval, governance, and accreditation of Institutional Review Boards (IRBs, known as CEPs in Portuguese), bringing greater legal certainty to the sector. Topics …

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About Us
Practice Areas
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In Focus
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São Paulo | SP

Dr. Ruth Cardoso Avenue, 8501,
17th Floor, Pinheiros District
Postal Code 05425-070
Phone +55 11 3530 8400

Rio de Janeiro | RJ

Visconde de Pirajá Street, 250,
7th Floor, Ipanema District
Postal Code 22410-000
Phone + 55 21 3590 6901

Porto Alegre | RS

Carlos Gomes Avenue, 700,
13th Floor, Auxiliadora District
Postal Code 90480-000
Phone + 55 51 3018 0500

Brasília | DF

SHIS, QL 08, Block 02,
House 01, Lago Sul District
Postal Code 71620-225
Phone + 55 61 3574 7808

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