WHO highly values Vietnam’s vaccine regulation system

Employees of the Company for Vaccine and Biological Production No 1 work on a COVID-19 vaccine candidate (Photo: VNA)

The National Regulatory Authority (NRA) of Vietnam has achieved Maturity Level 3 for vaccine regulation, the second highest level in the World Health Organisation (WHO)’s four-level NRA rating scale, the Ministry of Health said on April 7.

Level 3 represents a stable, well-functioning, and integrated regulatory system.

The ministry noted that the NRA assessment was conducted by using the Global Benchmarking Tool (GBT) of WHO to ensure the quality, safety, and effectiveness of vaccines.

The NRA of Vietnam was recognised to be well-functioning under the GBT in April 2015.

In 2018, WHO sent a team of international experts to Vietnam to re-assess this system basing on the updated GBT, which requires greater efforts to further complete NRAs, even those already recognised in 2015.

In the latest assessment, the NRA of Vietnam obtained Maturity Level 3 in eight of the nine vaccine regulating functions. Efforts are still being made to improve its maturity in terms of pharmaceuticals and other medical products.

The Health Ministry noted that the Vietnamese NRA has been maintained and developed over the past years to meet domestic vaccine demand, creating a prerequisite for this system to become a prestigious authority and export domestically made vaccines.

Vietnam is now capable of manufacturing 11 vaccines against 11 diseases (tuberculosis, diphtheria, whooping cough, tetanus, hepatitis B, Japanese encephalitis, cholera, typhoid, measles, rubella, polio) for the national expanded immunisation programme, along with many other vaccines such as seasonal influenza, H5N1 and rotavirus.

The country also has four developers of COVID-19 vaccines, and two of them are conducting clinical trials so as to debut their vaccines in 2021./.