Tough rules to control vaccine makers
Shaken by a scandal over the summer, authorities move to pass new laws
BEIJING: A draft law that aims to impose “the strictest” regulations on vaccines to ensure their safety and quality was submitted to China’s top legislature for review.
The draft vaccine management law, which was released by the State Administration for Market Regulation in November, had been approved by the State Council.
Elaborating on the draft for members of the National People’s Congress Standing Committee on Sunday, Jiao Hong, chief of the National Medical Products Administration, said it imposes the strictest regulatory system to date on vaccines, including on research, development, production, distribution and use.
The draft was made to improve China’s vaccine management system and eliminate regulatory loopholes exposed by the scandal involving Changsheng Biotechnology Co in Changchun, Jiao said.
The vaccine manufacturer, which is based in Jilin province, was found to have committed serious law violations by China’s drug authorities in July and August in connection with the production of a rabies vaccine. The violations included fabricating production records and using expired ingredients.
Under the draft released on Sunday, health and drug authorities will supervise the entire production chain of vaccines.
Drug authorities should also be more thorough in inspecting vaccine production sites, it says.
Manufacturers must digitally record data related to production and inspection of vaccines, and must also certify the authenticity, integrity and traceability of the data, according to the draft.