Kazakhstan becomes Central Asia’s first WHO ML3-certified medicines regulator

KAZAKHSTAN—Kazakhstan has reached a historic milestone in public health by becoming the first country in Central Asia to attain Maturity Level 3 (ML3) under the World Health Organization’s classification of national regulatory authorities.

This achievement signals that the nation has established a stable, integrated regulatory system for medicines and imported vaccines that aligns with international benchmarks.

Recognition of strong health leadership

Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized that Kazakhstan’s accomplishment reflects robust political commitment to building resilient health infrastructure.

By strengthening its regulatory capacity, the country has enhanced disease preparedness, expanded equitable access to quality medicines, and bolstered global health security.

These regulatory investments prove essential for protecting public health and advancing universal healthcare coverage across the region.

The ML3 designation emerged from a thorough WHO benchmarking process using the Global Benchmarking Tool, which evaluates the maturity and performance of national regulatory systems.

This rigorous assessment supports countries in continuously improving their regulatory frameworks as part of WHO’s broader initiative to enhance regulatory capacity worldwide.

What ML3 Status means for patients and public health

Countries achieving ML3 possess the technical expertise and institutional infrastructure to independently assess and authorize health products before they enter the market.

This capacity reflects well-functioning health authorities capable of making science-based decisions regarding product quality, safety, and effectiveness.

Furthermore, these regulatory bodies maintain ongoing market surveillance, promptly identifying and responding to safety concerns, including those posed by substandard or counterfeit medications.

Regulatory authorities operating at ML3 or ML4—the highest classification level—become eligible for WHO Listed Authority designation after additional performance assessments.

This recognition enables them to influence global regulatory standards and support other nations strengthening their own systems.

Kazakhstan’s regulatory framework

The Ministry of Health directs Kazakhstan’s regulatory system through two key institutions: the Committee for Medical and Pharmaceutical Control and the National Center for Expertise of Medicines and Medical Devices.

Together, these bodies manage the complete lifecycle of medicines and vaccines, from initial evaluation and authorization through market surveillance and ongoing safety monitoring.

Dr Hans Henri P. Kluge, WHO Regional Director for Europe, described the achievement as a major advancement for public health and regional leadership.

For Kazakhstan’s nearly 20 million citizens, the designation provides greater assurance that available medicines and vaccines are safe and quality-assured.

The milestone strengthens health security not only within Kazakhstan but throughout Central Asia and beyond.

Looking forward

Kazakhstan’s achievement establishes favorable conditions for increased regulatory transparency, innovation, and accelerated access to priority health products.

The country now stands as a reference point for regulatory excellence across the region.

The WHO will continue supporting Kazakhstan in maintaining and strengthening its regulatory capacity, recognizing that sustained investment in robust regulatory systems remains essential for ensuring universal access to safe and effective health products.