Vietnam has won recognition from the World Health Organization (WHO) as having a fully-equipped national regulatory system that ensures the safety and efficacy of vaccines produced and used domestically, thanks to which it can possibly become a vaccine supplier for the United Nations.

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The Southeast Asian country’s regulatory system for vaccines was officially certified on Monday as complying with international standards, the WHO said in a press release.

The NRA (National Regulatory Authority) certificate was presented the same day to Vietnamese Minister of Health Nguyen Thi Kim Tien by Dr. Shin Young-soo, regional director of the WHO’s Western Pacific Region.

“Vietnam now has a fully-equipped national regulatory system that ensures the safety and effectiveness of vaccines they produce and use,” Dr. Shin said.

The certificate is a great result for both the regulators and Vietnamese people because it confirms that vaccines produced in the country are quality assured to international standards of production, safety, and effectiveness, according to the WHO expert.

“This accomplishment should serve as an inspiration to other countries in the region and the world,” he added.

Following the recognition, Vietnamese vaccine manufacturers are eligible to apply for WHO prequalification of specific products.

It is expected that vaccines from Vietnam could be prequalified in the next one or two years.

“The eventual ability of United Nations procuring agencies to source vaccines from Vietnamese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality,” the WHO said in the same press release.

The results of the WHO assessment are thus not only good news for Vietnam, but also for the rest of the world, at a time when the number of countries producing vaccines is declining, according to the United Nations health agency.

The certification is the culmination of over a decade of intensive effort by the Vietnam NRA office to implement a roadmap – developed by national experts, with continuous advice from the WHO – to strengthen capacity for regulation of vaccines.

In April this year, a team of independent experts evaluated the Vietnam NRA for vaccines, and found that it met all of WHO criteria for functioning at international standards of excellence.

The certificate means that the Vietnam NRA is compliant in all areas required to provide regulatory oversight of vaccines: overall system frameworks; marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials.

“For local residents, it means that vaccines used by Vietnam’s national immunization program are now certified safe and effective,” the WHO said.

Any vaccine product must have high quality ensured, and it is particularly important to have effective regulatory oversight of vaccines because they are used on a population-wide basis, and are usually given to healthy infants, according to the WHO.

The WHO will continue to periodically evaluate Vietnam’s national regulatory authorities against international standards to determine and assure the quality of regulatory oversight.

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