Vietnamese national regulatory authority meets international standards for vaccine regulation

As vaccines are used on a population-wide basis and are usually given to healthy infants, effective regulatory oversight is especially important. The World Health Organisation has formally certified that Vietnam has a fully equipped national regulatory system that ensures the safety and efficacy of vaccines produced and used in the country.

The certification means that Vietnam’s national regulatory authority is compliant in areas such as overall system framework, marketing authorisation and licensing, post-marketing surveillance (including post-immunisation adverse events), lot release, laboratory access, regulatory inspections of manufacturing sites and distribution channels, and the authorisation and monitoring of clinical trials.

For the people of Vietnam, it means that vaccines used in the country’s national immunisation programme are now certified as safe and effective. The certification is the culmination of more than a decade of intensive effort by the NRA office to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen the regulation of vaccines.

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

‘Vietnam 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 Vietnam, because it confirms that vaccines produced in Vietnam 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.