Kazakhstan

The primary regulatory authority for health products in Kazakhstan is the Ministry of Health of the Republic of Kazakhstan, with day-to-day registration and control functions carried out by the Committee for Medical and Pharmaceutical Control (CMPC). The principal governing legislation includes the Code of the Republic of Kazakhstan on Public Health and the Healthcare System (2020), the Law on Circulation of Medicines and Medical Devices, and associated ministerial orders that define registration procedures, quality standards, and post-market surveillance requirements. All pharmaceuticals, medical devices, diagnostics, and digital health solutions intended for the Kazakhstani market must undergo a formal state registration process administered by the CMPC, resulting in a Registration Certificate that must be renewed periodically, typically every five years.

Applicants are required to submit a full registration dossier aligned with Common Technical Document (CTD) format for pharmaceuticals, while medical devices follow a risk-based classification framework consistent with IMDRF principles. A local legal representative or authorized representative registered in Kazakhstan is mandatory for foreign manufacturers. Kazakhstan is a member of the Eurasian Economic Union (EAEU), and mutual recognition of registrations granted under the unified EAEU regulatory framework is progressively being implemented, allowing products registered via the EAEU unified procedure to gain market access across member states. Recent reforms have focused on digitizing submission processes through the e-registration portal, introducing expedited review pathways for orphan, innovative, and pandemic-critical products, and aligning post-market surveillance requirements more closely with international best practices.

Public procurement of health products in Kazakhstan is centrally coordinated through the Ministry of Health, with the Single Distributor model playing a dominant role in pharmaceutical and medical device supply for the state-guaranteed benefit package. The Single Distributor, SK-Pharmacy (a state-owned enterprise), manages centralized purchasing on behalf of the government, conducting national-level tenders for pharmaceuticals, vaccines, and certain medical devices. Procurement procedures are governed by the Law on Public Procurement and relevant healthcare regulations, requiring that products hold a valid Kazakhstani Registration Certificate prior to participation in tenders. Regional health departments and individual healthcare facilities may conduct supplementary procurement for items outside centralized contracts, but the central tender mechanism covers the majority of publicly funded expenditure.

The private sector constitutes a significant and growing channel, encompassing private hospital networks, retail pharmacy chains, and outpatient clinics that source products independently through authorized distributors. Donor-funded procurement, while less prominent than in lower-income markets, exists through agencies such as UNICEF, the Global Fund (for HIV, tuberculosis, and malaria programs), and the World Health Organization, particularly for public health and essential medicine initiatives. Kazakhstan maintains policies that provide preferences to locally manufactured products and goods produced within EAEU member states in public tenders, including price preferences of up to 20 percent for domestic producers. These localization incentives have encouraged multinational manufacturers to explore contract manufacturing arrangements with Kazakhstani partners as a strategy to remain competitive in public tender processes.