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.
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.
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.
EMA Establishes Procedure for Scientific Advice on High-Risk Medical Devices
EMA has announced the implementation of a new standard procedure for scientific advice for manufacturers of high-risk medical devices.
PGEU has published the 2024 Medicine Shortages’s annual report
The PGEU has reported widespread medicine shortages across all 28 countries in 2024, with pharmacists spending more time managing the issue.
New Regulation on Medicine Availability in Portugal
Resolution No. 233/2025 updates medicine availability regulations, strengthening supply chains and export controls to prevent shortages in Portugal.
RDC No. 947: Anvisa Shifts to 100% Digital Protocol Processes
With Resolution RDC No. 947, Anvisa aims to reduce costs associated with storing and digitizing physical documents, while ensuring the authenticity and integrity of the documents by requiring the use of electronic signatures.
Sammed available for 2024 H2 Marketing Report Submission – Ensure Compliance for 2025
The Medicines Market Monitoring System (Sammed) is open for 2024 H2 marketing report submissions. Meet the March 14, 2025 deadline to qualify for the 2025 drug price adjustment.
Anvisa updates the Reference Medicines List.
The National Health Surveillance Agency (ANVISA) has updated the Reference Drug List, which classifies medications into groups based on their composition.