Received: 01 August 2026
Accepted: 01 October 2026
Published online: 30 October 2026
UDC: 615.33:614.27(574)
DOI: 10.53511/pharmkaz.2026.5.19
Article type: Original Research Article
ANTIBIOTIC REGISTRATION STATUS IN KAZAKHSTAN: ANALYSIS AND PRIORITY AREAS
Aldiyarova N.T.¹, Makalkina L.G.¹,², Kaliyeva Sh.S.¹,³
¹ Republican Public Association “Professional Association of Clinical Pharmacologists and Pharmacists”, Astana, Kazakhstan
² NJSC “Astana Medical University”, Astana, Kazakhstan
³ NJSC “Karaganda Medical University”, Karaganda, Kazakhstan
Introduction. Rational antibiotic prescribing depends not only on clinical decision-making but also on which medicines are actually available to clinicians. When essential Access antibiotics are unavailable, treatment choices may shift toward broader-spectrum agents, whereas in severe infections caused by multidrug-resistant pathogens, access to selected Reserve antibiotics becomes critically important. Therefore, effective implementation of rational antibiotic use programs requires both appropriate prescribing and access to the necessary medicines.
Objective. To assess the registration status in the Republic of Kazakhstan and the Eurasian Economic Union (EAEU) of antibiotics included in the 2025 WHO Model List of Essential Medicines, taking into account the WHO AWaRe classification, and to identify priority areas for improving the registration availability of clinically important antibiotics in the Republic of Kazakhstan.
Materials and methods. A descriptive comparative analysis was conducted of the registration status of antibiotics included in the 2025 WHO Model List of Essential Medicines (WHO EML), with verification of valid registration in the State Register of Medicinal Products of the Republic of Kazakhstan and the Unified Register of Registered Medicinal Products of the EAEU. The assessment was performed at the level of international nonproprietary name (INN), Anatomical Therapeutic Chemical (ATC) code, dosage form, and route of administration; registration status was recorded as of June 30, 2026. Discontinued, expired, suspended, or revoked registrations were not included. For medicines not registered in Kazakhstan, clinical relevance, availability of equivalent therapeutic alternatives, and the potential impact of registration on rational antibiotic use were additionally considered.
Results. The targeted dataset comprised 21 Access, 12 Watch, and 9 Reserve entries. Seven of the 21 main Access medicines lacked valid registration, along with certain additional formulations; oral vancomycin was absent in Watch, and five of nine Reserve medicines were unregistered. The largest number of clinically important unregistered medicines or formulations belonged to the Access group. In Kazakhstan, phenoxymethylpenicillin, benzathine benzylpenicillin, parenteral clindamycin, cephalexin, antistaphylococcal penicillins, and several other medicines or required dosage forms were not registered. In the Watch group, the most clinically significant missing option was oral vancomycin. Among Reserve antibiotics included in the WHO EML 2025, cefiderocol, intravenous fosfomycin, meropenem/vaborbactam, plazomicin, and tedizolid were not registered; however, intravenous fosfomycin was already registered within the EAEU.
Discussion. Registration coverage differed across the Access, Watch, and Reserve groups and between dosage forms. Lack of a valid registration may restrict the range of authorized treatment options but does not, by itself, establish shortages in healthcare facilities. The proposed expert-based priorities are preliminary and should be assessed against antibiotic consumption, local resistance patterns, and clinical need.
Conclusion. The identified limitations may have clinical significance. Insufficient representation of Access antibiotics restricts the ability to select therapy with the narrowest appropriate spectrum and to perform antimicrobial de-escalation, whereas the absence of several Reserve antibiotics limits treatment options for infections caused by multidrug-resistant organisms. The most feasible measures include assessing the possibility of registration or recognition of selected medicines, establishing a national list of critically important antibiotics, and implementing regular monitoring not only of registration status but also of procurement, actual availability, and consumption.
Keywords: antibiotics, medicine availability, medicinal product registration, AWaRe, Access, Watch, Reserve, antimicrobial resistance, rational antibiotic use.
