A new draft law that aims to intensify management of vaccines to ensure their safety and quality, approved by China’s State Council, will be submitted to the top legislature for approval.
The draft of the Vaccine Management Law, released by the State Administration for Market Regulation in November, was approved by the Education, Science, Culture and Public Health Committee of the National People’s Congress on Sunday, the committee said in a statement on Sunday.
The draft will be submitted to the National People’s Congress Standing Committee for review, the statement said.
Jiao Hong, chief of the National Medical Products Administration, which is under the State Administration for Market Regulation, while elaborating the draft to members of the NPC Standing Committee on Sunday, said the draft imposes the strictest supervision system on vaccines, including research and development, production, circulation and use.
Producers must use digital means to record data concerning production and inspection of vaccines, and ensure authenticity, integrity and tractability of these data, according to the draft.
Approval procedures and inspections must cover every batch of vaccines before they enter the market, it said.
Health and drug authorities should supervise the whole chain of vaccines, covering their research and development, production, circulation and use, and drug authorities should intensify site inspection of vaccine production and dispatch inspectors to vaccine producers, the draft said.
Serious law violators, such as those producing fake or substandard vaccines, will receive harsher penalties, according to the draft of the law. In such cases, senior executives and others involved will have all their pay related to the violations confiscated and pay fines, and they may be banned for life from engaging in the pharmaceutical business.