Kazakhstan Becomes First in Central Asia to Achieve WHO’s Key Medicines and Vaccines Regulatory Milestone

WHO Regional Director for Europe, Dr Hans Henri P. Kluge, described the achievement as a “major step forward for public health” and a strong indicator of leadership in the region.

Kazakhstan has reached a major milestone in public health, becoming the first country in Central Asia to achieve Maturity Level 3 (ML3) for the regulation of medicines and imported vaccines under the World Health Organization’s (WHO) global classification system.

The designation signals that Kazakhstan now operates a stable, well-functioning and internationally aligned regulatory system, capable of ensuring that medicines and vaccines entering the country meet rigorous standards of quality, safety, and efficacy.

Global Recognition of Strong Health Governance

The achievement follows a comprehensive WHO benchmarking process using the Global Benchmarking Tool (GBT)—a globally recognised framework that evaluates the performance and maturity of national regulatory authorities.

“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.

She added that strengthening regulatory capacity is key to enhancing preparedness, expanding equitable access to health products, and reinforcing global health security.

What Maturity Level 3 Means

Reaching ML3 indicates that Kazakhstan has developed robust technical expertise and institutional systems to:

• Independently evaluate and approve medicines and vaccines before use

• Ensure compliance with international standards

• Conduct post-market surveillance to monitor safety and effectiveness

• Detect and respond quickly to substandard or falsified products

This level of regulatory maturity reflects the country’s ability to make science-based decisions and maintain ongoing oversight throughout the lifecycle of health products.

Strengthening Public Trust and Health Security

WHO Regional Director for Europe, Dr Hans Henri P. Kluge, described the achievement as a “major step forward for public health” and a strong indicator of leadership in the region.

“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,” he said.

The milestone is expected to enhance public trust in the healthcare system, while also strengthening regional and global health security.

Integrated Regulatory System Driving Progress

Kazakhstan’s regulatory framework is led by the Ministry of Health and implemented through key institutions, including:

• The Committee for Medical and Pharmaceutical Control (CMPC)

• The National Center for Expertise of Medicines and Medical Devices (NCEMMD)

Together, these bodies oversee the entire lifecycle of health products, from initial evaluation and authorisation to ongoing monitoring and safety management.

Gateway to Global Leadership in Regulation

Countries that achieve ML3—and especially those reaching the highest level, ML4—may become eligible for designation as WHO Listed Authorities, allowing them to play a more influential role in shaping global regulatory standards.

Kazakhstan’s progress positions it as a regional leader and reference point for strengthening regulatory systems across Central Asia.

Benefits for Patients, Industry, and Innovation

The achievement is expected to deliver wide-ranging benefits, including:

• Faster and more reliable access to essential medicines and vaccines

• Improved regulatory transparency and efficiency

• Enhanced investment climate for the pharmaceutical sector

• Support for innovation and international collaboration

It also opens pathways for regulatory reliance, enabling faster approval of priority health products through cooperation with other trusted regulatory systems.

Sustained Investment Key to Future Progress

While the ML3 designation marks a significant achievement, WHO emphasises the need for continued investment to maintain and further strengthen regulatory systems.

Ongoing collaboration between WHO and Kazakhstan will focus on:

• Enhancing regulatory performance

• Expanding capacity and expertise

• Ensuring long-term access to quality-assured health products

As global health challenges continue to evolve, Kazakhstan’s milestone highlights the critical role of strong regulatory systems in safeguarding public health and advancing universal health coverage.