New list of critical drugs. Ministry of Health collects comments until July 8
Author: Luiza Jakubiak • Source: Rynek Zdrowia • Added: 07 July 2025 13:30 • Updated: 07 July 2025 13:30
The Ministry of Health has published another draft of the critical drugs list. It includes 99 active substances. The first list had 238 such items.
- The draft of the second National List of Critical Medicines has been published
- The list includes 99 active substances, the deficiencies of which could negatively affect the therapies of Polish patients and pose serious challenges to the healthcare system.
- Consultations on the list last until 8 July.
The Ministry of Health has published a draft of the second National List of Critical Medicines, the aim of which is to include additional active substances, the shortages of which could negatively affect the therapies of Polish patients and pose serious challenges to the healthcare system.
The first draft list was presented in November last year. It contained 238 items. After taking into account comments on the draft, the list was published in December 2024. Ultimately, it contained 301 active substances.
The current project has 99 active substances:
1. Acidum ursodeoxycholicum2. Adenosinum3. Albuminum (Iodine, 125I)4. Albuminum (Technetium, 99mTc)5. Anakinrum6. Aqua pro injection7. Atracurium8. Avibactamum9. Basiliximabum10. Bedaquilinum11. Brentuximabum vedotinum12. Busulfanum13. Captopril14. Cefepimum15. Ceftolozanum + Tazobactamum16. Cisatracurium17. Dapsonum18. Daunorubicini hydrochloridum19. Denosumabum20. Desmopressinum21. Dexmedetomidinum22. Epinephrinum23. Eptifibatidum24. Esketamine25. Esomeprazolum26. Etomidatum27. Factor IX coagulationis humanus28. Factor VIII coagulationis humanus29. Factor X coagulationis humanus30. Fidaxomicinum31. Flecainidi acetas32. Flumazenilum33. Foscarnetum natricum hexahydricum34. Ganciclovirum35. Gemtuzumabum ozogamicinum36. Glatirameri acetas37. Heminum humanum38. Ibrutinibum39. Idarucizumabum40. Imiglucerasum41. Imipenem+Cilastatinum42. Immunoglobulinum humanum anti-D43. Immunoglobulinum humanum hepatitidis B44. Immunoglobulinum humanum tetanicum45. Immunoglobulinum rabicum46. C1-esterase inhibitor, humanus47. Inotuzumabum ozogamicini48. Isavuconazolum49. Isoprenalinum50. Calla iodium51. Labetalolum52. Methylergometrinum53. Mexiletini hydrochloridum54. Milrinonum55. Mitotanum56. Mitoxantronum57. Moxifloxacinum58. Mycophenolas mofetil59. Natrii iodidum(131I) solution60. Natrii Nitroprussiatum61. Natrii thiosulfas62. Nevirapinum63. Nilotinibum64. Nimodipinum65. Oxacillinum66. Pentamidinum67. Phytomenadionum68. Piperacillinum + Tazobactamum69. Plerixaforum70. Posaconazolum71. Procarbazinum72. Progesteronum73. Prothrombinum74. Radium dichloridum Ra22375. Remifentanilum76. Riluzolum77. Rocuronii bromidum78. Sacituzumabum govitecanum79. Salmeterolum80. Sirolimusum81. Somatostatinum82. Sufentanilum83. Sugammadexum84. Diphtheria, tetanus vaccine85. Tick-borne encephalitis vaccine86. Rotavirus vaccine, live87. Teicoplaninum88. Tenecteplasum89. Thalidomidum90. Thiotepum91. Thrombinum bovinum92. Tiotropium93. Treosulfanum94. Tretinoinum95. Tuberculini derivatum proteinosum purificatum ad usum humanum96. Verteporfinum97. Vigabatrinum98. Vismodegibum
99. Zidovudin
According to the Ministry of Health, when preparing the update of the list, active substances included in the second edition of the European List of Critical Medicines published on December 16, 2024 were taken into account, as well as proposals for active substances that were submitted, among others, by national consultants in healthcare, the Chief Pharmaceutical Inspector, the President of the Office for Registration of Medicinal Products, and ministries and other institutions participating in the functioning of the domestic pharmaceutical market.
Similarly to the creation of the first National List of Critical Medicines, the criteria for assessing the criticality of specific active substances were adopted, appropriately selected and adapted to national conditions, including: adapted to national treatment regimens, availability of medicinal products on the Polish market, as well as the average monthly sales volume and information on the categories of availability of medicinal products within individual active substances and ATC codes.
The assessment of clinical criticality made by National Consultants in healthcare (taking into account the number of available equivalents, alternative medical therapies in a given indication, the impact of the lack of a given drug on the risk to the life or health of patients) and the opinions of the Chief Pharmaceutical Inspector and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, taking into account the places of manufacture, were also taken into account.
The deadline for submitting comments on the project is 8 July.
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