Kazakhstan has summarized the results of an audit conducted by the World Health Organization the Global Benchmarking Tool (GBT), an international methodology designed to objectively evaluate the maturity of national regulatory authorities responsible for medicines and medical devices.
The assessment represents an important step for Kazakhstan as it seeks international recognition as a country with a sustainable and effective regulatory system for health products.
WHO Global Benchmarking Tool Assessment
The Global Benchmarking Tool is used by the World Health Organization to evaluate regulatory systems across countries. The methodology measures the performance, capacity, and maturity of national authorities responsible for overseeing the safety, quality, and effectiveness of medicines and medical devices.
Through this assessment process, regulatory systems are evaluated across several key functions, including regulatory oversight, product authorization, safety monitoring, and market surveillance.
Strengthening National Regulatory Systems
The audit conducted under the Global Benchmarking Tool framework enables countries to identify strengths within their regulatory infrastructure while highlighting areas where further development may be required.
For Kazakhstan, participation in the WHO benchmarking process supports efforts to strengthen regulatory governance, improve public health protection, and align national regulatory practices with international standards.
Countries that undergo this benchmarking process demonstrate their commitment to building resilient regulatory frameworks capable of supporting safe access to medicines and medical technologies.
During the closing ceremony of the mission’s final day, Akmaral Alnazarova, Minister of Health of the Republic of Kazakhstan, highlighted the national commitment to strengthening the country’s regulatory framework. In her remarks, she stated that ensuring the quality, safety, and efficacy of medicines remains an absolute priority of state policy. The Minister also emphasized the importance of building a sustainable, modern, reliable, and transparent regulatory system that serves the interests of patients and supports the work of the medical and scientific community.
Supporting Regulatory Compliance and Oversight
Strong regulatory systems require structured compliance frameworks, effective safety monitoring mechanisms, and well-documented regulatory processes. Organizations operating in regulated pharmaceutical markets often rely on structured regulatory support and pharmacovigilance frameworks to maintain alignment with evolving international expectations.
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Ensuring data integrity and reliable safety monitoring systems also plays an important role in supporting regulatory oversight and inspection readiness across global markets.
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International Recognition and Future Outlook
Completing the WHO Global Benchmarking Tool assessment represents a key milestone in Kazakhstan’s efforts to strengthen its regulatory environment. By aligning with internationally recognized evaluation methodologies, the country continues working toward international recognition as a jurisdiction with a mature and effective regulatory system for medicines and medical devices.
For more information: Kazakhstan summarized the results of the WHO mission to assess the regulatory system.
