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 overarching legal framework is governed by the Code of the Republic of Kazakhstan 'On Public Health and Healthcare System' (2020), supplemented by specific regulations on the registration of pharmaceuticals, medical devices, and diagnostics. All health products must undergo state registration before they can be legally marketed or procured in Kazakhstan. The registration process involves submission of a dossier to the CMPC, scientific evaluation, laboratory testing where required, and issuance of a registration certificate valid for five years, after which renewal is required. Medical devices are classified by risk class (I, IIa, IIb, III), with higher-risk products subject to more rigorous conformity assessment procedures.

Applicants are generally required to appoint a local authorized representative or a legal entity registered in Kazakhstan to submit and manage registration dossiers. Kazakhstan accepts dossiers formatted according to the Common Technical Document (CTD) standard, and increasingly recognizes registration decisions from reference regulatory authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Eurasian Economic Union (EAEU) member state regulators, which can facilitate an expedited or simplified review pathway. As a member of the EAEU, Kazakhstan is harmonizing its regulatory framework with the EAEU's unified rules for pharmaceuticals and medical devices, meaning EAEU-registered products may benefit from streamlined mutual recognition procedures. Recent reforms have focused on digitizing the registration portal, reducing administrative backlogs, and aligning local Good Manufacturing Practice (GMP) inspection standards with international norms to improve transparency and predictability for foreign manufacturers.

Public procurement of health products in Kazakhstan is centralized through the Ministry of Health, with the Unified Distributor, SK-Pharmacy (a state-owned enterprise), serving as the primary national aggregator for the purchase and distribution of pharmaceuticals, vaccines, medical devices, and diagnostics funded through the Guaranteed Volume of Free Medical Care (GVFMC) and the Compulsory Social Health Insurance (CSHI) package. Tenders are conducted electronically via the national e-procurement platform (goszakup.gov.kz) in accordance with the Law of the Republic of Kazakhstan 'On Public Procurement' (2015). Regional healthcare departments and individual healthcare facilities may also conduct supplementary local procurements within defined thresholds, though strategic and high-value categories remain centrally managed. Inclusion on the Kazakhstan National Formulary and the List of Registered Health Products are prerequisites for participation in public tenders, making early regulatory registration a critical step for market access.

The private sector in Kazakhstan represents a growing share of health product consumption, particularly in urban centers such as Almaty and Nur-Sultan, with procurement conducted through private pharmacy chains, hospital groups, and wholesale distributors operating independently of the SK-Pharmacy mechanism. Donor-funded procurement channels play a more limited but notable role: Kazakhstan has historically received support through UNICEF supply division for childhood immunization, and Global Fund grants have supported HIV, tuberculosis, and malaria commodity procurement, though the country's upper-middle-income status has led to a gradual transition toward self-financing in these program areas. The government maintains an active policy of supporting local manufacturing through preferential procurement margins of up to 15-20 percent for domestically produced health products, as well as requirements for technology transfer and localization under certain state contracts. Manufacturers with local production partnerships or in-country assembly operations are therefore competitively advantaged in public tender evaluations.