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Major hepatitis B vaccine makers, Shenzhen-based BioKangtai, Beijing Tiantan Biological Products Co Ltd and Hualan Biological Engineering Inc, announced they failed to get certification for the new version of the Good Manufacturing Practice for Pharmaceutical Products on Tuesday.
Failure to win approval of the new regulation means the three major suppliers of free hepatitis B vaccines, which account for more than 90 percent of the market, are banned from producing related vaccines from Jan 1, according to Chinese web portal 163.com.
However, the three suppliers said that the regulation will not affect sales and uses of the vaccines that were produced before Jan 1.
Meanwhile, the failure does not mean they cannot win approval in the near future.
This latest development follows recent incidents in which 11 newborns died after being inoculated against hepatitis B.
Any possible link between the vaccines and the deaths has still to be confirmed pending ongoing investigations.
yaojing@chinadaily.com.cn
