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