WHO sup­ports Chi­nese vac­cine play­ers to meet global stan­dards

BioSpectrum (Asia) - - ANALYSIS -

The reg­u­la­tion of vac­cines is ex­tremely im­por­tant. It is the main means for the gov­ern­ment to en­sure that vac­cines pro­duced and used in China are safe, high qual­ity and ef­fec­tive. This in­ci­dent shows that po­ten­tial risks can be cir­cum­vented when reg­u­la­tion is ef­fec­tive. Ef­fec­tive drug pro­duc­tion qual­ity man­age­ment and reg­u­la­tion is to pre­vent prob­lems and en­sure vac­cine qual­ity. But once prob­lems are dis­cov­ered, reg­u­la­tors must take ac­tion. WHO com­mends the China State Food and Drug Ad­min­is­tra­tion for tak­ing swift and trans­par­ent ac­tion to stop its pro­duc­tion and in­ves­ti­gate the in­ci­dent.

WHO con­ducted two as­sess­ments of China’s na­tional drug reg­u­la­tory au­thor­i­ties in 2010 and 2014. The re­sults show that the na­tional drug reg­u­la­tory de­part­ment has met the stan­dards of the WHO’s fully func­tion­ing reg­u­la­tory body and has clearly promised to con­tinue to im­prove. WHO wel­comes the con­tin­ued co­op­er­a­tion of the China Na­tional Food and Drug Ad­min­is­tra­tion with WHO’s strength­en­ing of na­tional reg­u­la­tory au­thor­i­ties, which has been un­der way for nearly 20 years. This in­ci­dent is un­doubt­edly re­gret­table, but the in­ci­dent was dis­cov­ered by flight in­spec­tion. It also shows that the sys­tem su­per­vi­sion and on­site in­spec­tion of the reg­u­la­tory au­thor­i­ties can ef­fec­tively pro­tect peo­ple’s health.

WHO re­it­er­ates that re­li­able vac­cines are es­sen­tial for dis­ease pre­ven­tion and en­cour­ages coun­tries to con­tinue to adopt this cost-ef­fec­tive pub­lic health in­ter­ven­tion. China’s ex­panded im­mu­niza­tion pro­gram has been ef­fec­tive, al­low­ing China to achieve po­lio-free sta­tus and sig­nif­i­cantly re­duc­ing vac­cine-pre­ventable dis­eases such as measles, mumps, rubella, hep­ati­tis A and hep­ati­tis B among chil­dren. To this end, WHO also sup­ports Chi­nese vac­cine man­u­fac­tur­ers to meet in­ter­na­tional stan­dards and WHO pre-cer­ti­fi­ca­tion re­quire­ments.

- Dr. Gao Li, World Health Or­ga­ni­za­tion

Rep­re­sen­ta­tive in China

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