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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]