The Drug Market Regulation Chamber (CMED) has published Resolution CM/CMED No. 3/2025, which establishes a new regulatory framework for the pricing of medicines in Brazil, replacing rules that had been in force for more than two decades. The resolution introduces...
Regulatory
ANVISA reinforces deadline for labeling compliance for simplified-notification medicines
The Brazilian Health Regulatory Agency (“ANVISA”) has published a communication reminding companies of the need to fully align the labeling of medicines subject to simplified notification with the requirements established under RDC 768/2022, as updated by RDC...
Overturning of the vetoes to the new Environmental Licensing Framework: impacts on agribusiness and the productive sector
On November 27, 2025, the National Congress overturned most of the presidential vetoes to the new environmental licensing framework. The decision reinstates provisions that simplify steps and expedite licensing procedures, particularly for activities classified as low...
ANVISA Publishes RDC 998/2025 on Occupational and Non-Dietary Exposure Risk Assessment for Pesticides
The Brazilian Health Surveillance Agency (“ANVISA”) has published Resolution 998/2025, which establishes technical and procedural requirements for assessing occupational, residential, and bystander risks related to the use of pesticides and related products. The...
BPTO proposes regulation of alternative claim sets in patents to streamline examination and align with international practices
A public event on December 2 will discuss the new regulation, which aims to offer greater flexibility to users and reduce the average time for patent grants. The Brazilian Patent and Trademark Office (BPTO) will hold an event on December 2 to discuss the regulation...
Technological Litigation and Judicial Sovereignty: reflections of the OAB-RJ ICT Commission on the limits of anti-suit injunctions
On November 4, the Information and Communication Technologies Commission of the Brazilian Bar Association - Rio de Janeiro Section (OAB-RJ) held a lecture titled “Maintaining the sovereignty of Brazilian courts over ICTs registered in national territory”, bringing...
STJ Sets New Deadline for Regulation of Hemp Cultivation for Medical and Pharmacological Purposes
On November 6, the Superior Court of Justice (STJ) approved a new timeline submitted by the Federal Government and established an additional 145 days for the publication of the regulatory act governing the cultivation of hemp for medical and pharmacological purposes....
Anvisa opens Public Consultations to revise nutrition labeling requirements for packaged foods
Anvisa has published Public Consultations No. 1,357/2025 and 1,358/2025, launching a comprehensive review of Brazil’s nutrition labeling regulation, a major development for the food, beverage, and supplements industries. The proposal introduces a new RDC that...
MAPA issues Circular Letter No. 14/2025 on therapeutic equivalence of veterinary medicines
On September 4, 2025, the Ministry of Agriculture and Livestock (MAPA), through the Coordination for the Registration of Veterinary Products (CORPV/CGIPE/DSA/SDA), issued Circular Letter No. 14/2025, establishing guidelines for demonstrating therapeutic equivalence...
Decree No. 12.651/2025 regulates Law No. 14.874/2024 on research with human beings
On October 7, 2025, Decree No. 12.651/2025 was published, regulating provisions of Law No. 14.874/2024, also known as the "Brazilian Clinical Trials Law". The Decree aims to operationalize provisions of the Law, especially with regard to the structuring and...
MAPA issues Act No. 40/2025 on pesticide registration applications
On September 2, 2025, Act No. 40/2025 was published, establishing significant changes to the procedures for filing pesticide registration applications. As of September 15, 2025, new registration and post-registration applications for pesticides and related products...
ANVISA’s Resolution 894/2024 comes into force on August 28 and requires mandatory reporting of serious cosmetic adverse events
On August 28, 2025, ANVISA’s Collegiate Board Resolution – RDC 894/2024 will come into force, establishing Good Cosmetovigilance Practices for companies responsible for registering cosmetic products with the agency. The regulation sets out a series of...
New Environmental Licensing Guidelines – Presidential Vetoes and Government Proposals Aim to Ensure Legal Certainty and Streamline Strategic Projects
Written by: Viviane Kunisawa, Mariana Cuzziol and Estela Alves The Brazilian President has vetoed 63 provisions of Bill No. 2,159/2021, which establishes Brazil’s new Environmental Licensing framework. While the vetoes targeted provisions considered by the Government...
ANVISA approves RDC No. 983/2025, amending RDC No. 843/2024 and establishing a phase-out period for food and beverage packaging
Written by: Estela Alves, Mariana Cuzziol and Viviane Kunisawa On July 28, 2025, the Brazilian Health Regulatory Agency (ANVISA) published Resolution of the Collegiate Board (RDC) No. 983/2025 in the Official Gazette of the Union (“DOU”). This resolution amends RDC...
Law No. 15,183 of July 30, 2025, prohibiting cosmetic testing on animals is enacted
Written by: Estela Alves e Mariana Cuzziol On July 30, 2025, Law No. 15,183 was enacted by the President of Brazil and published in the Official Gazette (“DOU”). The law amends Laws No. 11,794/2008 and No. 6,360/1976 and establishes the prohibition of the use of...