New Chinese quality standards raise the risk of a hep B vaccine shortage

An article from FierceVaccines
January 2, 2014

China's push to raise manufacturing standards was always likely to result in a few hiccups as companies raced to bring production plants into line with new regulations. And with the deadline for producers of injectables now having passed, it appears the hepatitis B vaccine market faces a tricky few months.

Dalian Hissen BioPharm, Shenzhen BioKangtai and Beijing Tiantan Biological Products are all missing from the latest list of companies with good manufacturing practice (GMP) certification. Companies that failed to obtain GMP clearance by Dec. 31, 2013, are banned from producing new products, but they can continue selling old stock. As of October the three companies reportedly supplied 80% of hepatitis B vaccines sold in China, Global Times states, with each holding a little more than one quarter of the sector.

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