Tougher rules set to control vaccine makers

Shaken by a scandal over the summer, authorities move to pass new laws

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 on Sunday. 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 Bio-technology 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.

Approval procedures and inspections must cover every batch of vaccines before they enter the market. Authorized institutes must inspect and approve vaccines, and report to China's top drug authority and provincial-level drug authorities if there are any major safety or quality risks found, so that they can be dealt with immediately.

Serious violations of the law, such as producing fake or substandard vaccines, will receive harsh penalties.

According to the draft, senior executives and those involved in the violations will have all their pay confiscated and will be fined as well. They may also be banned for life from conducting business in the pharmaceutical industry.

Tao Lina, a public health expert based in Shanghai, said drug authorities should make their inspection reports on vaccine procedures publicly available, rather than just listing the manufacturers that have passed inspections, so as to ensure that manufacturers improve the quality of their vaccines.

"Most vaccines can pass inspections and be approved for sale in China, but the quality of these vaccines varies," he said. "Some vaccines have high quality, but some may just barely pass the inspection."

By releasing data on the quality of vaccines, manufacturers will develop higher standards for quality and will have more incentive to keep improving product quality and reducing prices, Tao said.

"This can greatly reduce the cost of being supervised by authorities," he said.