Law No. 15,471, dated July 20, 2026, was published on July 21, 2026, establishing the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS), with the aim of strengthening the Health Economic-Industrial Complex (CEIS), reducing external...
Regulatory
Decree No. 13,014/2026 creates a new SisGen registration mechanism for legal entities domiciled abroad
On June 11, 2026, Decree No. 13,014/2026 was published, amending Decree No. 8,772/2016 (which regulates Law No. 13,123/2015, known as the Brazilian Biodiversity Legal Framework) and establishing the Association Term for registration purposes. The new rule allows...
CMED issues Resolution No. 3/2025 modernizing drug pricing rules in Brazil
On May 29, 2026, the Brazilian Drug Market Regulation Chamber (CMED) published Resolution No. 3/2025, which comes into force this Friday and updates Brazil’s drug pricing framework. The new regulation replaces rules established more than two decades ago, seeking to...
MAPA/SDA extends Public Consultation on the registration of generic and interchangeable similar veterinary medicines
Written by Mariana Cuzziol, Viviane Kunisawa and Rafael Barros On May 29, 2026, the Secretariat of Agricultural Defense of the Ministry of Agriculture and Livestock published Ordinance SDA/MAPA No. 1,634/2026, extending Public Consultation for an additional 45 days....
CMED postpones entry into force of Resolution No. 3/2025 amid ongoing discussions on drug pricing framework
On April 29, 2026, the Brazilian Drug Market Regulation Chamber (CMED) issued Resolution No. 6/2026, amending Resolution No. 3/2025, which sets forth the rules for drug pricing in Brazil. The new measure revises Article 52 of Resolution No. 3/2025 to extend its...
First Instance Decision Recognizes Patent Term Adjustment in Gilead Case Based on Excessive BPTO Delay
A recent first instance decision in Brazil has brought renewed attention to patent term adjustment litigation. In a relevant development, the judge accepted a patent term adjustment request filed by Gilead, recognizing that excessive and unjustified delay during...
ANVISA advances discussions on the regulation of medicinal cannabis production in Brazil
The Brazilian Health Regulatory Agency (ANVISA) held, on January 28, 2026, the first Public Meeting of the Collegiate Board (Dicol) of 2026 to discuss proposals for regulating the production of medicinal cannabis in Brazil, in compliance with a determination issued by...
ANVISA launches Targeted Consultation on medicinal product brand names
The Brazilian Health Regulatory Agency (“ANVISA") has launched a Targeted Consultation aimed at gathering technical input and stakeholder experience regarding the rules applicable to medicinal product brand names, currently governed by RDC No. 59/2014. This initiative...
Resolution No. 3/2025: Structural Changes to Brazil’s Drug Pricing Framework
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...
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....