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.
First Guidance to Provide Comprehensive Recommendations for Artificial Intelligence in Medical Devices for Developers
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.
First Guidance to Provide Comprehensive Recommendations for Artificial Intelligence in Medical Devices for Developers
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.
The National Health Surveillance Agency (Anvisa) recently updated its guidelines on the procedures for classifying border products.
Portugal has already exported 18,521 kg of medicinal cannabis, and aims to reach 25 tons by the end of 2024.
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.
This update aims to make Brazil an even more attractive environment for investment in clinical research and to strengthen the health innovation ecosystem.
This tool allows users to check and follow up on documents issued, as well as consult the analysis queue for these records.
