National Regulatory Authority of Viet Nam Meets International Standards for Vaccine Regulation



Hanoi - 22 June 2015 - As of today, the World Health Organization formally certifies Viet Nam has a fully-equipped national regulatory system that ensures the safety and efficacy of vaccines produced and used in Viet Nam.

Effective regulatory oversight of vaccines is especially important, as vaccines are used on a population-wide basis, and are usually given to healthy infants. Therefore high quality must be assured.

The certificate means that Viet Nam’s National Regulatory Authority is compliant in all areas required to provide regulatory oversight of vaccines: overall system framework; 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 the people of Viet Nam it means that vaccines used by Viet Nam’s national immunization programme are now certified safe and effective. All vaccines under Viet Nam’s national Expanded Programme on Immunization (EPI) are free of charge, without shortage of supply, available at commune health centers across Viet Nam.

The certification is the culmination of over a decade of intensive effort by the NRA office to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen capacity for regulation of vaccines. In April of this year, a team of independent experts evaluated the Viet Nam NRA for vaccines, and found that it has met all of the WHO criteria for functioning at international standards of excellence.

The results of the WHO assessment are good news for Viet Nam, but also for the rest of the world. The demand for vaccines is increasing at a time when the number of countries producing vaccines is declining.

With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in Viet Nam are now eligible to apply for WHO prequalification of specific products. It is expected that vaccines from Viet Nam could be prequalified 1-2 years from now. 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.

“Viet Nam now has a fully-equipped national regulatory system that ensures the safety and effectiveness of vaccines they produce and use. This is a great result for the regulators, but an even better result for the people of Viet Nam, because it confirms that vaccines produced in Viet Nam are quality assured to international standards of production, safety, and effectiveness. This accomplishment should serve as an inspiration to other countries in the Region and the world,” said Dr Shin Young-soo, Regional Director of WHO’s Western Pacific Region.

Dr Shin will present the NRA certificate to Associate Professor Nguyen Thi Kim Tien, the Minister of Health of Viet Nam, at a ceremony in Hanoi on 22 June 2015.

WHO will continue to periodically evaluate Viet Nam’s NRAs against international standards to determine and assure the quality of regulatory oversight.

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