Kazakhstan

The primary regulatory authority for health products in Kazakhstan is the Ministry of Health of the Republic of Kazakhstan, operating through its subordinate expert body, the National Center for Expertise of Medicines, Medical Devices and Medical Equipment (NCEM). The overarching legal framework is established by the Code of the Republic of Kazakhstan 'On Public Health and the Healthcare System' (most recently revised in 2020), supplemented by specific government resolutions and ministerial orders governing the registration, quality control, and circulation of pharmaceuticals, medical devices, diagnostics, and digital health solutions. All health products must undergo state registration before they may be marketed or procured in Kazakhstan, with the NCEM responsible for conducting scientific expert review of submitted dossiers and issuing registration certificates, which are generally valid for five years and subject to renewal.

Applicants are required to appoint a local authorized representative or a registered legal entity in Kazakhstan to submit and maintain registration dossiers. Kazakhstan accepts dossiers prepared in accordance with the Common Technical Document (CTD) format, and as a member of the Eurasian Economic Union (EAEU), the country increasingly aligns its registration procedures with the unified EAEU regulatory framework, allowing products registered under the EAEU-wide procedure to circulate across member states including Russia, Belarus, Armenia, and Kyrgyzstan. Key submission requirements include GMP certificates or equivalent manufacturing compliance documentation, clinical evidence packages, labeling in the Kazakh and Russian languages, and, for medical devices, conformity assessment documentation such as CE marking or equivalent. Recent reforms have focused on accelerated registration pathways for innovative and orphan products, strengthened pharmacovigilance obligations, and progressive harmonization with EAEU technical regulations and ICH guidelines.

Public procurement of health products in Kazakhstan is centralized primarily through the Ministry of Health, with the unified purchasing function coordinated by the Social Health Insurance Fund (SHIF, known as FOMS) and executed via the state-owned enterprise 'SK-Pharmacy,' which serves as the national single distributor for guaranteed volume benefit packages under the compulsory social health insurance system. Tenders are conducted through the electronic government procurement portal (goszakup.gov.kz) in accordance with the Law on Public Procurement (2015, as amended), and procurement decisions are based on a combination of price, quality, and compliance criteria. A meaningful share of the public health budget is channeled through regional health departments for facility-level and emergency procurement, though strategic centralization continues to expand, particularly for high-cost pharmaceuticals, vaccines, and diagnostic equipment.

The private sector constitutes a growing share of health product consumption in Kazakhstan, served by a network of commercial distributors, pharmacy chains, and private hospital groups that source products independently through direct manufacturer agreements or regional distributors. Kazakhstan participates in procurement support programs coordinated by international organizations, including UNICEF for vaccine and child health commodity procurement, and has historically engaged with Global Fund mechanisms for HIV, tuberculosis, and malaria-related diagnostics and medicines, although the country has transitioned toward greater domestic financing as an upper-middle-income economy. Government policy actively encourages local manufacturing through preferential procurement margins granted to domestically produced goods under public tender rules, as well as industrial partnership and technology transfer requirements for certain product categories, in alignment with the national industrial development program 'Economy of Simple Things' and broader EAEU localization incentives.