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.
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 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 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.
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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 has announced the implementation of a new standard procedure for scientific advice for manufacturers of high-risk medical devices.
The PGEU has reported widespread medicine shortages across all 28 countries in 2024, with pharmacists spending more time managing the issue.
The PGEU has reported widespread medicine shortages across all 28 countries in 2024, with pharmacists spending more time managing the issue.
Resolution No. 233/2025 updates medicine availability regulations, strengthening supply chains and export controls to prevent shortages in Portugal.
