401 items. The Ministry of Health has published a new version of the National List of Critical Medicines

• The updated list of critical drugs includes Denozumab, Fidaxomicinum, Glatirameri acetas, and Nevirapinum – substances used in the treatment of osteoporosis, intestinal infections, multiple sclerosis, and HIV, among others.
• The new version of the list, published by the Ministry of Health, has 401 items – 100 more than the first list from December 2024.
• The list was created based on, among others, the analysis of the EU list of critical drugs and proposals from experts, institutions and medical communities, taking into account criteria such as availability and place of production.
• The aim of the list is to ensure uninterrupted access to key therapies, support domestic drug production and strengthen drug safety in Poland and the entire EU.

The list includes, among others, Denozumab, a drug used to treat osteoporosis and mainly used to treat gastrointestinal infections, the antibiotic Fidaxomicinum, Glatirameri acetas - a drug for patients with multiple sclerosis - and Nevirapinum - indicated in combination with other antiretroviral drugs in HIV-infected patients.

More than six months have passed since the publication of the first version of the list of drugs whose presence on the Polish market is intended to ensure patient safety. In December 2024, the Ministry of Health published a list of 301 active substances. This list includes drugs whose shortages could negatively impact patient access to therapy and pose significant challenges to the healthcare system.

– We want to ensure uninterrupted access to medicines, ensure that medicines are produced domestically, ensure durable and uninterrupted supply chains, ensure stable sources of supply of active substances and additional medicines, and develop incentives for producers to invest in the production of active substances in our country – explained Deputy Minister of Health Marek Kos during the presentation of the first list.

The ministry announced that the new version of the list has 401 items, which is one hundred more than the previous one.

- When preparing the update of the list in question, the analysis included active substances that were included in the second edition of the European List of Critical Medicines published on December 16, 2024, but were not included in the first National List of Critical Medicines, as well as proposals for active substances that were submitted by national health care consultants, the Chief Pharmaceutical Inspector, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, ministries (...), responsible entities and the social side - a total of 296 items - explained the Ministry of Health in a press release.

When compiling the list, the Ministry also considered factors such as clinical criticality, manufacturing locations, equivalents and availability, average monthly sales volume, and availability of medicinal products containing a given active ingredient. The list is available on the Ministry of Health's website .

On June 30th of this year, the six-month Polish Presidency of the European Union ended . One of its priorities was drug safety. During the process, draft EU regulations were adopted, emphasizing the relocation of drug production to EU member states and providing direct financial incentives, administrative simplifications, and easier access to public tenders for entities that meet the EU's targets.

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