Việt Nam’s vaccine regulatory system reaches WHO’s second-highest level

April 14, 2021 - 15:23
The World Health Organisation (WHO) has recently announced that Việt Nam’s National Regulatory Authority (NRA) for vaccines reached Maturity Level 3, the second highest in the WHO classification of national regulatory system.


Researching embryonated chicken eggs for vaccine production at a facility of the Institute of Vaccines and Medical Biologicals, which is also developing a COVID-19 vaccine based on its existing flu vaccine manufacturing process. — VNA/VNS Photo

HÀ NỘI The World Health Organisation (WHO) has recently announced that Việt Nam’s National Regulatory Authority (NRA) for vaccines reached Maturity Level 3, the second highest in the WHO classification of national regulatory system.

Classification is carried out by WHO’s Global Benchmarking Tool (GBT) which assesses a number of functions and criteria to ensure the quality, safety, and effectiveness of vaccines distributed in the country.

In 2015 April, Việt Nam's vaccine regulatory authorities achieved the “Functional” status against WHO Vaccine Assessment Tool.

In 2018 November, a WHO team comprising of international experts re-assessed Việt 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.

Việt Nam’s NRA for vaccines has been maintained and enhanced in recent years to meet the domestic demand including vaccines in the National Expanded Programme on Immunisation, as well as to be the trusted authorisation body so that domestic vaccines could be exported to other countries, contributing 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 Việt Nam, congratulated the country on this achievement.

“This accomplishment reaffirms the continuous collaboration between the Government of Việt Nam and WHO in achieving universal access to safe, effective and affordable vaccines,” he said.

“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.”

Currently, Việt Nam has managed to produce 11 vaccines to prevent 11 diseases covered under the expanded immunisation programme (tuberculosis, diphtheria, pertussis/whooping cough, tetanus, hepatitis B, Japanese encephalitis, cholera, typhoid, measles, rubella, poliomyelitis), in addition to other types of vaccines like seasonal flu, H5N1 influenza, and rotavirus.

Four Vietnamese vaccine manufacturers and developers are researching locally made COVID-19 vaccines, with two – Nano Covax by HCM City-based pharmaceutical company Nanogen and COVIVAC by the Institute of Vaccines and Medical Biologicals – already in human trials.

The frontrunner in the race, Nano Covax, is expected to obtain licence for circulation within 2021. — VNS