Achieving World Health Organization (WHO) approval allows Chinese vaccine manufacturers to apply for prequalification, which is needed to supply United Nations (UN) procurement agencies.
“The eventual ability of UN procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality”, said the WHO.
China has 36 vaccine plants with a total annual capacity of 1bn doses, according to the State Food and Drug Administration (SFDA), and as such could make a significant contribution to global supplies.
Prequalification is expected to take up to two years. The WHO plans to initiate the process by discussing “a roadmap towards submission of applications from manufacturers for prequalification of individual vaccines”.
The SFDA failed to win WHO approval in 1999, 2001 and 2005. Gaining approval is the result of “19 months of intensive effort by the SFDA to implement a roadmap – developed by national experts, with continuous advice from WHO – to strengthen capacity for regulation of vaccines”.
Assessment of progress was made by WHO officials on visits to vaccine regulatory institutes in Beijing, Shanghai and provinces of Hebei and Jiangsu. Regulatory inspections of manufacturing sites and distribution channels were among the area assessed by WHO officials.
It is critical regulatory capacity gains made in efforts to win approval are maintained and built upon, said the WHO. To support further improvements the WHO has “drawn up a detailed institutional development plan”.
Outlined in the Ministry of Health-approved plan are actions to further strengthen regulatory capacity in China. The WHO will guide businesses towards prequalification and “is committed to providing further support to assist the regulatory authority in making continuous improvements”.