New historical and regulatory milestone for cannabis in Brazil: ANVISA publishes new RDCs (Collegiate Board Resolutions) and advances the regulation of medicinal cannabis.
The Collegiate Board Resolutions (RDC) No. 1,011/2026, No. 1,012/2026, No. 1,013/2026, No. 1,014/2026, and No. 1,015/2026 were published in the Official Gazette of the Union, establishing provisions on cannabis regulation in Brazil.
Anvisa promotes direct consultation on new regulatory framework for medical devices
The National Health Surveillance Agency (Anvisa) has announced the opening of a targeted consultation on the new proposal for a federal regulatory framework for medical devices. The initiative will be launched at a virtual event on May 13, at 9am (Brasília time), via the Microsoft Teams platform.
Public Consultation on Medicinal Cannabis Products: Anvisa’s Main Proposals
As of April 4, 2025, Anvisa launched a public consultation (CP 1.316/2025) to update the rules on cannabis products for medicinal use in Brazil.
Anvisa publishes new resolution on Good Manufacturing Practices for Medicines
Anvisa (National Health Surveillance Agency) published Collegiate Board Resolution (RDC) No. 972/2025 in the Federal Official Gazette last Wednesday, April 23, 2025. The new text updates RDC 658/2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicines in Brazil.
Public Consultation on the Revision of RDC 327/2019: Main Changes and Criticisms
On March 26, 2025, the public consultation on the revision of RDC 327/2019, which regulates the health authorization, manufacture, import, marketing, prescription and inspection of cannabis-based products for medicinal purposes in Brazil, was approved.
ANVISA Resolution No. 964/2025 published: Requirements for Forced Degradation Studies on Medicines
ANVISA Resolution No. 964 was published in the Federal Official Gazette (DOU) on February 24, 2025, establishing general requirements for conducting Forced Degradation Studies on medicines containing synthetic and semi-synthetic active pharmaceutical ingredients (APIs). The resolution also defines the parameters for the notification, identification and qualification of degradation products in these drugs. Below, we summarize the most important points of this new regulation.
FDA Proposes New Front-of-Package Nutrition Label to Help Consumers Make Healthier Choices
FDA proposes a new front-of-package nutrition label to help consumers make healthier food choices, focusing on key nutrients like saturated fat, sodium, and added sugars, promoting better public health.
Resolution No. 954: Changes to Drug Registration Take Effect
What changes with Anvisa Resolution No. 954? The new regulation, set to take effect on January 21, 2025, introduces adjustments to drug registration, post-registration, and renewal processes, enhancing transparency and sanitary control.
FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions
FDA releases comprehensive guidance draft with recommendations on the use of artificial intelligence to support regulatory decisions regarding the safety, efficacy, and quality of drugs and biologics.
Anvisa Updates Procedures for Borderline Products
The National Health Surveillance Agency (Anvisa) recently updated its guidelines on the procedures for classifying border products.