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.
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.
APMC Conducts Innovative Study on Medicinal Cannabis for Osteoporosis and Chronic Pain in Women
The Pan American Association of Cannabinoid Medicine (APMC) is leading an innovative study on the use of medicinal cannabis in the treatment of osteoporosis and chronic pain in women. The research investigates bone biomarkers and genetic polymorphisms to personalize therapies and expand access to treatment within the SUS.
EU Regulation 2021/2282 on Health Technology Assessment Enters into Force
As of January 12, the EU regulation comes into effect to facilitate access to innovative medicines and medical devices, with INFARMED actively contributing to its implementation.
FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions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.