Kazakhstan

The primary regulatory authority for health products in Kazakhstan is the Committee for Medical and Pharmaceutical Control (CMPC) under the Ministry of Health of the Republic of Kazakhstan. The principal governing legislation includes the Code of the Republic of Kazakhstan 'On the Health of the People and the Healthcare System' (2020) and the Law 'On Circulation of Medicines and Medical Devices.' All health products, including pharmaceuticals, medical devices, diagnostics, and digital health solutions, must undergo state registration before they may be marketed or procured in Kazakhstan. The registration process involves submission of a dossier to the CMPC, technical and clinical evaluation, laboratory testing where required, and issuance of a registration certificate, which is typically valid for five years and subject to renewal.

Applicants are required to appoint a local authorized representative or a legal entity registered in Kazakhstan to submit and maintain product registrations. Dossiers are generally accepted in Common Technical Document (CTD) format, and Kazakhstan, as a member of the Eurasian Economic Union (EAEU), increasingly aligns its registration procedures with the unified EAEU regulatory framework, allowing mutual recognition of registrations across member states including Russia, Belarus, Armenia, and Kyrgyzstan. Notable recent reforms include the progressive adoption of EAEU good manufacturing practice (GMP) standards, the introduction of electronic submission portals, and efforts to streamline registration timelines for priority health products. Local clinical data may be required in certain circumstances, and post-market surveillance obligations have been strengthened in recent years.

Public procurement of health products in Kazakhstan is centralized through the Ministry of Health, with the Single Distributor model playing a dominant role. The Single Distributor, currently SK-Pharmacy (a state-owned enterprise), is responsible for the centralized procurement and distribution of pharmaceuticals, vaccines, medical devices, and diagnostics for the guaranteed volume of free medical care (GVFMC). Tenders are conducted through the state procurement portal (goszakup.gov.kz) in accordance with the Law 'On Public Procurement' (2015). National tender procedures prioritize registered products and, in many categories, apply preferences for goods produced locally or within EAEU member states, with domestic manufacturers benefiting from a price preference margin of up to 20 percent. Regional health departments may conduct supplementary procurement for facility-level needs outside the centralized framework.

The private sector in Kazakhstan represents a meaningful share of health product consumption, operating through commercial pharmacy chains, private hospitals, and distributor networks, with procurement conducted independently of state tender processes. Kazakhstan also receives support from international donor and multilateral organizations, including UNICEF, which supports vaccine and essential medicine supply chains, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which finances procurement of diagnostics and treatment commodities for disease-specific programs. USAID-supported programs have historically contributed to health systems strengthening and supply chain capacity. Local manufacturing preference policies are actively promoted through the 'Made in Kazakhstan' initiative and pharmaceutical industry development programs, incentivizing in-country production and technology transfer partnerships as part of the national industrial policy agenda.