Kazakhstan has achieved a major public health milestone, becoming the first country in Central Asia to reach Maturity Level 3 (ML3) for the regulation of medicines and imported vaccines under the World Health Organization’s (WHO) global classification of national regulatory authorities. This designation recognizes that the country has a stable, well-functioning and integrated regulatory system for medicines and imported vaccines that meets international standards.
“This milestone underscores Kazakhstan’s strong political commitment to building resilient health systems and ensuring timely access to safe, effective and quality-assured health products,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “By investing in regulatory capacity, the country is strengthening preparedness, advancing equitable access, and contributing to a more secure and interconnected global health landscape. Such efforts are essential to safeguarding public health, reinforcing global health security and advancing universal health coverage.”
The ML3 designation follows a rigorous WHO benchmarking process using the Global Benchmarking Tool (GBT), which assesses the maturity and performance of national regulatory systems while supporting their continuous improvement as part of WHO’s broader work to strengthen regulatory capacity worldwide.
Countries that reach ML3 have the technical expertise and systems in place to formally evaluate and approve health products before they can be imported, distributed and used in the country. This reflects well-functioning health authorities capable of making independent, science-based decisions on the quality, safety and efficacy of these products. They can also monitor these products once they are on the market and quickly detect and respond to any safety issues, including those caused by substandard or falsified products.
Regulatory authorities operating at ML3 and ML4, the highest level in WHO’s GBT classification, may be eligible for designation as WHO Listed Authorities, subject to additional performance assessments, enabling them to play a more prominent role in advancing global regulatory standards.
Kazakhstan’s national regulatory system, led by the Ministry of Health, is implemented through the Committee for Medical and Pharmaceutical Control (CMPC) and the National Center for Expertise of Medicines and Medical Devices (NCEMMD). Together, these institutions oversee the full lifecycle of medicines and vaccines, from evaluation and authorization to market surveillance and safety monitoring.
“Kazakhstan’s achievement of Maturity Level 3 is a major step forward for public health and a strong sign of leadership,” said Dr Hans Henri P. Kluge, WHO Regional Director for Europe. “It reflects the country’s progress in building a stable, well-functioning and integrated regulatory system – the bedrock of trust between a government and its people. For nearly 20 million people in Kazakhstan, it means greater confidence that the medicines and imported vaccines they rely on are safe, effective and quality-assured. It will also strengthen health security in Kazakhstan, across Central Asia and beyond.”
Kazakhstan’s progress is expected to generate lasting benefits for patients, health-care providers and industry alike. Achieving ML3 creates favourable conditions that promote greater regulatory transparency, foster innovation and support reliance pathways that can help accelerate access to priority health products. It also reinforces Kazakhstan’s position as a reference point and leader in regulatory systems’ strengthening across the region.
WHO will continue to work closely with Kazakhstan to maintain and further strengthen its regulatory capacity. Sustained investment in regulatory systems remains essential to ensure that all people have access to safe, effective and quality-assured health products.