ASTANA, Kazakhstan, March 30. Kazakhstan has reached the third level of maturity of its national medicines regulatory system under the World Health Organization (WHO) assessment, strengthening its attractiveness for investment in the pharmaceutical sector, Trend reports via the country’s Ministry of Healthcare.
The development was highlighted during the Indian-Kazakh pharmaceutical business forum held in New Delhi, which brought together more than 60 Indian pharmaceutical companies producing medicines, raw materials, medical devices, vaccines, and biotechnology products.
The achievement makes Kazakhstan the first country in the Commonwealth of Independent States (CIS) and the fourth in the WHO European Region to reach this level, confirming compliance with international standards of quality, safety, and efficacy of medicines.
Reaching the third maturity level means that Kazakhstan’s regulatory system meets global requirements in drug registration, quality control, pharmacovigilance, and manufacturing inspections, increasing confidence among international organizations, investors, and manufacturers.
According to the ministry, ensuring the accessibility and effectiveness of drug provision remained a key focus in 2025, with 3.6 million people across the country receiving free medicines under state programs, covering 15.6 million prescriptions worth 262.9 billion tenge ($543.8 million).
The ministry also noted that the list of medicines has been updated, with ineffective drugs removed and a stronger focus placed on modern and innovative treatments.
For reference, the World Health Organization (WHO) classifies national medicines regulatory systems on a scale from 1 to 4 using its Global Benchmarking Tool, which assesses more than 250 indicators, including drug approval, quality control, and safety monitoring. Reaching maturity level 3 indicates that a country has a stable and functioning regulatory system aligned with international standards and capable of overseeing the full lifecycle of medicines.
Countries that have achieved this level include, among others, Türkiye, Saudi Arabia, Vietnam, and Egypt. In practical terms, this status allows national regulators to be recognized by international partners, which can facilitate participation in global pharmaceutical supply chains, simplify export procedures, and support cooperation with international procurement mechanisms. It is also considered an important factor for foreign companies when assessing regulatory predictability and market entry conditions.
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