Hanoi, 12 April 2021 – The World Health Organization (WHO) announced that Viet Nam’s National Regulatory Authority (NRA) for vaccines reached Maturity Level 3, the second highest in the WHO classification of national regulatory system.
The said WHO classification is carried out by employing WHO’s Global Benchmarking Tool (GBT) assessing a number of functions and criteria to ensure the quality, safety, and effectiveness of vaccines distributed in Viet Nam.
In April 2015, Viet Nam's vaccine regulatory authorities achieved the “Functional” status against WHO Vaccine Assessment Tool. Three years later, in November 2018, a WHO team comprising of international experts re-assessed Viet Nam’s NRA using an updated and more comprehensive GBT (version V) with new functions and benchmarking criteria. It requires national regulatory authorities, including those who have been certified by WHO in 2015, to make great efforts to further improve their systems.
GBT evaluation results are presented as maturity levels on a scale of 1 to 4. Achieving Maturity Level 1 means some elements of regulatory system exist. Maturity Level 2 indicates evolving national regulatory system that partially performs essential regulatory functions. Maturity Level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, Maturity Level 4, is achieved by a regulatory system operating at advanced level of performance and continuous improvement.
Viet Nam’s NRA for vaccines has been maintained and enhanced in recent years to meet the domestic demand including vaccines in the Expanded Programme on Immunization, as well as to be the trusted authorization body so that domestic vaccines could export to other countries and contribute to the regional and global supply of vaccines. During the latest evaluation, Maturity level 3 was certified to NRA for vaccines in eight of the nine functions of regulating vaccines. Accelerated efforts are continuing to expand NRA maturity to medicines and other medical products.
Dr. Kidong Park, WHO Representative in Viet Nam, congratulated the country on this recent achievement as he remarked, “This accomplishment reaffirms the continuous collaboration between the Government of Viet Nam and WHO in achieving universal access to safe, effective and affordable vaccines. It is expected that the country’s regulatory system for medicines, vaccines and other medical products will transform further to become a more coherent and science-based national regulatory authority independent from political and commercial influence.”