Portugal’s Health Sector Exports Grow 21.6%, Surpassing €4 Billion in 2024
Portugal’s health sector has recorded impressive growth in exports in 2024, surpassing the 4,000 million euro mark, which represents an increase of 21.6% on the previous year. This increase reflects the dynamism of the sector, which remains strong even in a challenging global context.
ELS Group hosts webinar on the medicinal cannabis market in Europe
Join ELS Group for an Exclusive Discussion on the Future of Cannabis in Europe!
New Rules for Medicine Export Control in Portugal
INFARMED has introduced stricter export controls to prevent medicine shortages. Wholesale distributors must report exports, while manufacturers and pharmacies face less bureaucracy. These measures align with EU regulations, ensuring transparency and protecting national supply.
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.
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.
FDA issues preliminary guidance for medical devices with Artificial Intelligence
First Guidance to Provide Comprehensive Recommendations for Artificial Intelligence in Medical Devices for Developers
FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions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.
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.
Anvisa updates form for importing Cannabis-derived products
Anvisa has announced an update to the import form for Cannabis-derived products via express shipment, used in the Solicita system for individuals importing products for personal use.