New rules on research with human subjects in Brazil
In 2024, Law No. 14,874/2024 (“Clinical Research Law”) was enacted, establishing the baseline framework for research involving human subjects in Brazil. Since its publication, the Ministry of Health has undertaken studies to regulate the Law, focusing on institutional stability in support of clinical research. As a result of this effort, Decree No. 12,651/2025 (“Clinical Research […]
Brazilian National Congress approves the “Digital Brazilian Statute of the Child and Adolescent”
Bill No. 2,628/2022, known as the digital Brazilian Statute of the Child and Adolescent (“Digital ECA Bill”), has been approved by the Brazilian National Congress and is currently awaiting presidential approval. Introduced in response to growing public concern over the premature exposure of children to adult content and behaviors on social media platforms, the Digital […]
Compliance Aspects in the “Brazil Sovereign” Provisional Measure
Provisional Measure No. 1,309 (“PM”), of August 13, 2025, was enacted in direct response to the so-called tarifaço imposed by the United States, which established additional tariffs on various Brazilian products. As part of the Brazil Sovereign Plan, the measure sets forth an emergency package to mitigate the economic impacts of this trade barrier, encompassing […]
New law establishes quotas for women on boards of directors and disclosure obligations on gender equity
Law No. 15.177, of 23 July 2025, made important changes to Law No. 13.303/2016 (“State-Owned Companies Law”) and Law No. 6.404/1976 (“Brazilian Corporations Law”), with implications for state-owned companies, listed companies and corporations/joint-stock companies in general, as detailed and specified below. State-Owned Companies The new law establishes quotas for women on the boards of directors […]
CVM’s New Guidelines on Copytrade
Increasingly common in the investment universe (especially in alternative assets, such as crypto-assets), the Copytrade service – or portfolio replication – has been offered by various participants through electronic means. Given its novelty in the regulation of the securities markets in Brazil, the Superintendence of Institutional Investor Supervision (“SIN”) of the Brazilian Securities Commission (“CVM”) […]
Check out the public consultation on the regulatory framework for chemical products in Brazil
1. Introduction On November 13, 2024, Law No. 15.022/2024 was enacted, establishing Brazil’s National Inventory of Chemical Substances and setting forth rules for risk assessment and management of chemical substances utilized, produced, or imported into the country. Inspired by international best practices, particularly Europe’s REACH regulation, Law No. 15.022/2024 introduces, for the first time in […]
IOF and credit fintechs: key changes
Two new decrees – No. 12,466, dated May 22, 2025, and No. 12,467, dated May 23, 2025 – have amended the Brazilian financial transactions tax (IOF) rules levied on credit, insurance, and foreign exchange transactions. The changes have been in effect since May 23, 2025, except for advance payments and other financing transactions granted to […]
IOF changes for FX transactions: understand the new rules
Two new decrees – No. 12,466, dated May 22, 2025, and No. 12,467, dated May 23, 2025 – have amended the IOF rules for credit, insurance, and foreign exchange (FX) transactions. The changes have been in effect since May 23, 2025, except for those relating to advance payment and other financing transactions granted to suppliers, […]