06/04/2026
Public Consultation No. 1/2026 has been published by the National Research Ethics Authority (Instância Nacional de Ética em Pesquisa – “INAEP”), inviting public participation on the proposed new guidelines applicable to biobanks of human biological material, within the scope of the National System for Research Ethics Involving Human Beings (Sistema Nacional de Ética em Pesquisa …
11/03/2026
The Second Panel of the Federal Supreme Court (STF) unanimously denied the internal appeal filed by the Brazilian Federal Court of Accounts (TCU) and fully reinstated the legal effect of ANTAQ Resolution No. 72/22, reaffirming the possibility of charging the Container Segregation and Delivery Service (SSE). The controversy centered on the actions of the TCU, …
04/02/2026
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 …
08/01/2026
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 …
29/12/2025
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 …
19/12/2025
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 …
12/12/2025
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 …
09/12/2025
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 …
02/12/2025
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 …
25/11/2025
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 …