European Commission Presents Critical Medicines Act
On March 12, 2025, the European Commission took an important step in strengthening the European Union’s strategic autonomy with regard to the availability of essential medicines. It presented the Critical Medicines Act, a new initiative aimed at guaranteeing continuous access to essential medicines, preventing shortages and improving the resilience of supply chains in the pharmaceutical industry.
Update on Prior Notification of Medicines Transactions Abroad
On March 11, 2025, Information Circular No. 022/CD/100.20.200 was published, bringing important updates on the export of medicines.
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.
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.
Medicines Shortages in Europe: PGEU Report 2024 Points to Critical Scenario
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.
European Shortages Monitoring Platform: A New Era in Medicine Management
The European Shortage Monitoring Platform (ESMP), launched on January 29, 2025, enhances the monitoring and management of medicine shortages across the EU. It enables quicker responses and better crisis management in drug unavailability situations.