WHO highly values Vietnam’s vaccine regulation system

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.
WHO highly values Vietnam’s vaccine regulation system ảnh 1Employees of the Company for Vaccine and Biological Production No 1 work on a COVID-19 vaccine candidate (Photo: VNA)
Hanoi (VNA) - TheNational Regulatory Authority (NRA) of Vietnam has achieved Maturity Level 3 forvaccine 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 theNRA assessment was conducted by using the Global Benchmarking Tool (GBT) of WHOto ensure the quality, safety, and effectiveness of vaccines.

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

In 2018, WHO sent a team ofinternational experts to Vietnam to re-assess this system basing on the updatedGBT, which requires greater efforts to further complete NRAs, even thosealready recognised in 2015.

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

The Health Ministry notedthat the Vietnamese NRA has been maintained and developed over the past yearsto meet domestic vaccine demand, creating a prerequisite for this system tobecome a prestigious authority and export domestically made vaccines.

Vietnam is now capable ofmanufacturing 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 developersof COVID-19 vaccines, and two of them are conducting clinical trials so as todebut their vaccines in 2021./.
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