Brazilian Central Bank issues new rules on virtual assets
On November 10, 2025, the Brazilian Central Bank (“BCB”) published BCB Resolutions 519, 520, and 521 (collectively, the “New Rules”), which address: (i) the provision of virtual asset services in Brazil; (ii) the authorization process for rendering such services; (iii) the use of virtual assets in the Brazilian foreign exchange market; and (iv) the use […]
ANVISA launches package to reduce backlogs and streamline regulatory reviews
Measures cover drug registration, clinical trials, and expanded cooperation with international regulators On November 7, 2025, the Board of Directors of the Brazilian Health Regulatory Agency (Anvisa) approved a comprehensive package of structural and exceptional measures designed to address the Agency’s longstanding review backlog and enhance the overall efficiency and predictability of its regulatory decisions. […]
Bill proposes to expand CADE’s role in regulating digital markets
The Federal Government submitted Bill No. 4,675/2025 to Congress, proposing the creation of the Digital Markets Superintendence within CADE, a new authority with a significant role in the designation of agents with systemic relevance in the digital markets. The Bill provides that such agents may be subject to special obligations through a specific administrative proceeding. […]
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”) […]