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.
European Commission Launches Public Consultation on Medical Devices and In Vitro Diagnostics Regulations
The European Commission has launched a public consultation on medical device regulations. Participate by March 21, 2025, and contribute to their evaluation.
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.
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FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions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.
Portugal is the second-largest exporter of medicinal cannabis in 2024
Portugal has already exported 18,521 kg of medicinal cannabis, and aims to reach 25 tons by the end of 2024.
EMA launches a public consultation on the use of real-world data in the regulation of medicines.
The EMA opens a public consultation on the use of data in the regulation of medicines under the Data Quality Framework for the Regulation of Medicines.
Progress in Clinical Research in Brazil: New ANVISA Regulations
This update aims to make Brazil an even more attractive environment for investment in clinical research and to strengthen the health innovation ecosystem.
Anvisa publishes panels on Dossier Adequacy Letter for Active Pharmaceutical Ingredients
This tool allows users to check and follow up on documents issued, as well as consult the analysis queue for these records.