Beijing News Express (Reporter Xu Wen) The State Administration for Market Regulation today (November 11) announced the "Vaccine Management Law" (draft for soliciting opinions) on its official website and solicited public opinions. The Draft for Soliciting Opinions clearly states that subjective and intentional illegal acts such as data fraud will be severely punished. If the regulatory authorities participate in, shelter, and condone vaccine illegal and criminal acts, commit fraud, conceal facts, interfere with and obstruct liability investigation, or help forge, conceal or destroy evidence, they shall be held accountable in accordance with the law.
"Draft for Comments" was jointly drafted by the State Drug Administration and the National Health Commission. It is divided into 11 chapters, covering all aspects of vaccine development, production, circulation, and vaccination, and makes specific provisions on the special requirements for vaccine supervision. The deadline for feedback is November 25, 2018.
The Draft for Soliciting Opinions stipulates that serious illegal acts include five circumstances, namely, those who submit false clinical trials or marketing authorization application materials; those who fabricate verification records and change product batch number; those who submit false batch issuance application materials, or use other deceptive means to obtain batch issuance certificates; those who find that the vaccines sold on the market have quality problems or other safety hazards and fail to take recall measures; and other serious illegal acts with subjective intention.
For those who commit serious illegal acts, the illegal gains will be confiscated to the holder of the vaccine marketing authorization, and the holder of the vaccine marketing authorization will be ordered to suspend production and business. The certificate of marketing authorization will be revoked, and a fine of not less than five times but not more than ten times the value of the goods will be imposed; if the value of the goods is less than 500,000 yuan, a fine of not less than one million yuan and not more than five million yuan will be imposed. The legal representative, main person in charge and personnel in key positions of the vaccine marketing authorization will be confiscated to the income obtained from the unit during the illegal period, and a fine of not more than 50% or not more than one times will be imposed. No drug production and operation activities shall be engaged in ten years. If the circumstances are particularly serious, you shall not engage in drug production and operation activities for life.
"Draft for Soliciting Opinions" strengthens the accountability of regulatory departments and local governments, and stipulates that if regulatory departments fail to perform their duties or perform their duties incorrectly and cause serious consequences, and if local governments fail to organize and lead the organization and leadership, they will be held accountable in accordance with the law. Those who participate in, shelter, condone vaccine illegal and criminal activities, commit fraud, conceal facts, interfere with and obstruct liability investigation, or help forge, conceal or destroy evidence, shall be held accountable in accordance with the law.
