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.
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.