China Vaccine Regulators Are Now WHO Certified

China's national regulatory authority, the "State Food and Drug Administration" (SFDA), has been found to meet requirements for a functional vaccine regulatory system, per published indicators. According to a report by the World Health Organization, Chinese vaccine manufacturers will now be eligible for prequalification of specific products. The addition of Chinese vaccines to the world market is expected to "have a significant, beneficial impact on global supply of vaccines of assured quality."

http://www.who.int/immunization_standards/vaccine_regulation/nra_china_functional/en/

Excerpts from the report:

"A WHO-led team concluded today, at the end of a comprehensive review by experts from six countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO published indicators for a functional vaccine regulatory system."

"Effective regulatory oversight of vaccines is essential since vaccines are used on a population-wide basis, and are usually given to healthy infants. Furthermore, vaccines are produced in only a small number of countries and often exported from the country of manufacture to many countries. Countries importing vaccines need to be confident that the national regulatory authority in the country of origin is competent in its oversight. WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. WHO also conducts regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way."

"With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for Prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. Each application for prequalification of a specific product is independently evaluated by WHO. It is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality."