The newly promulgated Law of the People's Republic of China on Vaccine Management and the newly revised Law of the People's Republic of China on Drug Administration and the Implementation Regulations of the Food Safety Law of the People's Republic of China (hereinafter referred to as "two laws and one case") will all start on December 1, 2019. Effective from today. A few days ago, the person in charge of the Municipal Market Supervision and Administration Bureau answered questions from reporters on related issues of "two laws and one case."
Question: Please briefly introduce the background of the revision of "Two Laws and One Case".
党的十八大以来，习近平总书记对全面加强食品药品监管工作提出了一系列新要求，涉及监管原则、监管目标、监管体系、监管重点、监管方法等。 Answer: Since the 18th CPC National Congress, General Secretary Xi Jinping has put forward a series of new requirements for comprehensively strengthening food and drug supervision, involving supervision principles, supervision goals, supervision system, supervision focus, supervision methods, and so on. These requirements are summed up as "the four strictest" food safety, namely the strictest standards, the strictest supervision, the strictest punishment and the most serious accountability. The revision of "two laws and one case" fully implemented General Secretary Xi Jinping's "four strictest" requirements for food and drug safety.
The old "Regulations for the Implementation of the Food Safety Law of the People's Republic of China" (hereinafter referred to as the "Regulations") were revised in 2009, and the old "Drug Administration Law" was revised in 2001. Before the "Vaccine Management Law" was promulgated, Management is scattered in relevant laws and regulations, and there is no special legislation. Faced with the current new situation, new tasks, and new problems, it is necessary to amend the Regulations and the Drug Administration Law, to specialize legislation for vaccine management, and to further improve and perfect the food drug and vaccine management system.
Q: What are the highlights of the newly revised Regulations?
：整体来看，此次《条例》是对2015年新修订的食品安全法的进一步落实与细化，有利于解决实践中存在的问题与难点，为食品企业生产经营提供了明确的要求及依据。 A : On the whole, the "Regulations" is a further implementation and refinement of the newly revised Food Safety Law in 2015, which is conducive to solving problems and difficulties in practice, and provides clear requirements for the production and operation of food companies. in accordance with. Compared with the revised draft of the "Implementation Regulations of the Food Safety Law" announced by the former State Food and Drug Administration in 2015, it can be seen that the content of the "Regulations" has been expanded from 10 chapters 64 to 10 chapters 86 to strengthen the main corporate responsibility, The implementation of the "Double Penalty System" and the supervision of health food have been refined, highlighting the country's high emphasis on food safety issues.
Question: The production operator is the first person responsible for food safety. What regulations have been made in the regulations to further implement the responsibility of food safety principals of production operators?
《条例》从四个方面进一步强调了食品生产经营者的主体责任。 Answer: The Regulation further emphasizes the main responsibility of food producers and operators from four aspects. The first is to clarify the responsibilities of the main responsible persons of the enterprise, stipulating that the main responsible persons are fully responsible for the food safety work of the enterprise, and strengthen supplier management, purchase inspection and factory inspection, and control of production and operation processes. The second is to regulate the storage and transportation of food. It is stipulated that the storage and transportation of food with special requirements such as temperature and humidity shall have corresponding equipment and facilities and maintain effective operation. At the same time, the behavior of entrusting storage and transportation of food shall be regulated. Third, aiming at problems such as false publicity and illegal information release in practice to mislead consumers, it is explicitly forbidden to use any means including conferences, lectures, health consultations to make false publicity on food; stipulate that inspection agencies without qualification certification shall not be issued The food inspection information issued must not use the above information to grade foods. The fourth is to improve the special food management system and regulate the inspection of special foods, distribution channels, advertising management, and product naming.
Q: How does the "Regulations" reflect the "most severe punishment"?
新修订的条例首次确立了“双罚制”，也就是除处罚违法企业外，还规定了对单位违法情形下的个人罚款处罚，最高可处以上一年度从本单位取得收入的10倍罚款。 Answer: The newly revised regulations establish the “dual penalty system” for the first time, that is, in addition to penalizing illegal enterprises, they also provide for personal fines for violations of the unit, which can be punished up to 10 times the income obtained from the unit in the previous year. fine. According to the review of the penalties of the Regulations, the minimum amount of fines is 10,000 yuan, which is much higher than the minimum amount of 2,000 yuan before the amendment. For the release of food inspection information issued by an unqualified food inspection agency, or the use of the above-mentioned inspection information for rating assessment to deceive and mislead consumers, even a fine of 1 million yuan may be imposed. These all reflect the requirements of "the severest punishment".
In addition, the Regulations establish joint incentives for trustworthiness and joint punishment mechanisms for breach of trust. The Food Safety Supervision and Administration Department of the State Council, in conjunction with relevant departments of the State Council, has established a joint trustworthy incentives and untrustworthy disciplinary mechanism, combined with the credit files of food producers and operators, and established a blacklist system for serious illegal producers and operators. And credit information shall be announced to the public in a timely manner.
Q: What are the characteristics of the new Drug Administration Law?
与现行《药品管理法》相较，新《药品管理法》主要有以下特点：一是按照药品全生命周期进行篇章结构设计，同时突出了药品上市许可持有人对药品全生命周期管理的法律责任。 Answer: Compared with the current Drug Administration Law, the new Drug Administration Law has the following characteristics: First, the chapter structure design is based on the entire life cycle of the drug, and at the same time, it highlights the drug life cycle management by the holder of the drug marketing authorization. Legal liability. The second is to increase the post-marketing management of drugs, which is in line with the reform of “decentralized service” and global drug risk management trends, and strengthen the continuous and progressive management of drug risks. The third is to reflect the "severest punishment", a comprehensive use of multiple punishment measures, the implementation of the "dual punishment system" for some serious violations, punishment to people, and the amount of punishment has also been significantly increased.
Question: As a regulatory authority, how will the Municipal Market Supervision Bureau implement the "two laws and one case" in the next step?
美国法学家伯尔曼提出：“法律必须被信仰，否则它将形同虚设”。 Answer: The American jurist Berman proposed: "The law must be believed, or it will be useless." In the next step, the city's market supervision system will comprehensively strengthen the “two laws and one case” law popularization and law enforcement training, and continuously strengthen supervision capabilities, improve public acceptance and awareness, and work hard to make food and drug safety work on the track of the rule of law. run. Of course, studying, propagating and implementing the "two laws and one example" is the common responsibility of the people's governments at all levels and their relevant departments, food and drug production and management stakeholders, and the public at present and in the future. I also call on all relevant parties to actively participate in and strive to make these laws and regulations recognized, mastered, respected and believed by the broadest people.