In the face of growing challenges to drug availability in Europe, the Health Ministry has presented a new, expanded version of the National List of Critical Medicines. The document, which is crucial to securing the health needs of Poles, now includes 401 active substances - more than a hundred more than before.
Ministry of Health has updated the list of drugs essential for patient safety
Published July 15, 2025 07:25
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The update of the national list was carried out in connection with the publication of the second edition of the European Critical Medicines List, announced in December 2024. As the Health Ministry emphasizes, these measures are aimed at strengthening Poland's drug security - especially in the context of global disruptions in supply chains and a growing number of drug shortages.
Who decided and how?
In developing the update, not only European data was used, but also extensive national consultations. Among others, national consultants, the Chief Pharmaceutical Inspector, the President of the Office for Registration of Medicinal Products, as well as representatives of state institutions such as the Ministry of Defense, the Ministry of Internal Affairs and Administration, the National Health Fund and RARS were invited to cooperate. In the course of the work, 296 new proposals were analyzed, some of which were included in the list.
Each substance was evaluated in terms of:
- its clinical significance (i.e., how important it is for saving health and life),
- Availability (whether there are equivalents, where it is produced, whether there are shortages),
- average consumption per month,
- registration status and availability in pharmacies.
It was also recognized that any compounded preparation that contains at least one substance on the list can be considered a critical drug.
What's new on the list?
100 new active substances have been added to the list. Among them are both specialized preparations used in the treatment of rare diseases and in oncology (e.g. ibrutinib, gemtuzumab ozogamicin, vismodegib), as well as emergency life-saving drugs (epinephrine, remifentanyl, dexmedetomidine), antibacterial and antiviral agents (ceftolozane with tazobactam, gancyclovir, fidaxomicin), immunoglobulin drugs, anticoagulants, hormonal drugs, and vaccines - including those against diphtheria, tetanus, rotavirus and tick-borne encephalitis.
The list also shows how dependent modern medicine is on a stable supply of biological drugs and radioactive preparations - the list included technetium-99m, iodine-125 and radium-223.
List of critical drugs: TU
Source: MZ
