The official announcement is here! The State Food and Drug Administration discloses the latest progress in the development of new crown vaccine

Source: Medical Network

The Supreme People's Procuratorate, the State Administration of Market Supervision and Administration, and the State Drug Administration jointly issued 15 typical cases of special actions to implement the "four most stringent" requirements for food and drug safety. Regarding issues related to the "Four Strict" Special Actions, the heads of the Fourth Procuratorate of the Supreme People's Procuratorate, the Law Enforcement Inspection Bureau of the State Administration of Market Supervision, and the Department of Policies and Regulations of the State Drug Administration answered questions from reporters.

Question 1: Please tell us about the development of the "four most stringent" special actions.

Answer: Food and drug safety is directly related to the health and life safety of the people, and reflects the people's most concerned, most direct, and most realistic interests. The Party Central Committee has always attached great importance to it. General Secretary Xi Jinping has repeatedly made important efforts to strengthen food and drug safety. Instructions. In order to thoroughly implement the “four strictest” requirements of General Secretary Jinping’s food and drug safety supervision, and promote the establishment of a complete food and drug safety governance system, from September 2019 to December 2020, the Supreme People’s Procuratorate, the State Administration for Market Supervision and Administration, The State Drug Administration jointly launched a special action to implement the "four most stringent" requirements for food and drug safety. During the period, the national procuratorial organs, market supervision departments, and drug supervision departments adjusted measures to local conditions, intensified collaboration, adopted a variety of effective measures, and achieved positive results. According to preliminary statistics, the national market supervision department investigated and handled 284,800 food safety violations, fined 2.725 billion yuan, revoked 775 food administrative licenses, and transferred 3,346 cases to the public security organs; drug regulatory agencies investigated and dealt with violations in the fields of drugs, cosmetics, and medical devices There were 107,700 cases with a fine of 1.84 billion yuan, 2,041 companies were ordered to suspend production and business, 1,306 cases were transferred to the public security organs, and the annual inspections of all 37 vaccine manufacturers in production were completed, which effectively guaranteed the supply of influenza vaccines; the prosecutors approved the arrests of foods. There were 3,945 drug safety crime cases, 7,298 people, and 8,871, 17066 people were prosecuted; administrative law enforcement agencies were recommended to transfer 1,369 such criminal cases, 1,499 people, and supervise public security organs to file 731 cases, 810 people; 35,381 public interest lawsuits involving food and drug safety were filed and handled. 30,800 pre-litigation procedural cases were filed, and 1,683 public interest litigations were filed.

During the special action, local market supervision departments and procuratorial organs actively explored the establishment of working mechanisms such as mutual transmission of clues for suspected criminal cases and cases of harm to public interest, file transfer, research and judgment and consultation, public interest litigation cooperation and cooperation, etc., to create a full-chain supervision and assistance mechanism in the food safety field. Carry out in-depth investigations of hidden food safety hazards, improve food safety risk assessment and random inspection, and focus on strengthening regional and systematic food safety risk prevention and control. Joint procuratorial organs have strengthened the supervision of case filing, effectively promoting the resolution of issues such as not shifting the case, not filing a case, and substituting fines for penalties, and promote the effective implementation of the linkage mechanism between administrative law enforcement and criminal justice. The State Drug Administration organizes special inspections for selected drugs in national procurement, special random inspections for new drugs, comprehensive inspections of blood product manufacturers, special inspections for the production and operation of second-class psychotropic drugs, special treatment of high-value medical consumables, and sterile and implantable medical treatment Supervision and inspection of key products such as equipment, infants and special-purpose cosmetics. Insist on fighting chaos, organize and carry out special rectifications such as traditional Chinese medicine decoction pieces, drug online sales, medical equipment "cleaning nets", cosmetics "online nets, offline cleansing sources" and other special rectifications to protect the people's online consumption safety. Continuously improve and improve the legal system of drug supervision, promote the issuance and implementation of the "Regulations on the Supervision and Administration of Cosmetics", the "Regulations on the Supervision and Administration of Medical Devices" were reviewed and approved by the executive meeting of the State Council, and the "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production" were issued and implemented for implementation. Drug safety provides strong legal protection. The procuratorial organs fully perform their legal supervision functions and severely crack down on crimes endangering food and drug safety in accordance with the law. The Supreme People's Procuratorate supervised and guided a number of major and complicated cases such as the "water injection beef" case and the vaccine case, and promoted the handling of the cases. A national procuratorial organ’s economic crime procuratorial talent pool has been established, and professional experts can effectively play a leading and exemplary role. Provincial-level procuratorates have adopted methods such as supervision and participation to increase the intensity of guidance and supervision, and effectively curb crimes that endanger food and drug safety with a high-pressure posture. Procuratorates in Shanghai and other places set up a cross-regional "specialized case handling team in the food and drug field" to improve the quality and efficiency of handling food and drug cases and conduct in-depth research on difficult frontier issues. Some procuratorial organs have introduced "external brains" from universities and administrative law enforcement agencies to establish think tanks of experts in the food and drug field. The Supreme People’s Procuratorate, the Office of the Food Safety Commission of the State Council, the State Administration for Market Regulation and other ten units signed the "Opinions on Strengthening Cooperation and Cooperation in Prosecuting Public Interest Litigations to Ensure Food and Drug Safety in accordance with the Law", clarifying the transfer of clues and the jurisdiction of filing a case. Regulations. Local procuratorial organs actively broaden the channels for finding clues in administrative inspections and public interest litigation in the food and drug sector, strengthen internal linkage and external collaboration, improve cooperation mechanisms such as information exchange, situation reporting, and consultation on difficult issues, and create a good supervision atmosphere. Adhere to the combination of individual case supervision and category case supervision, and actively play the role of procuratorial advice. Regarding the regulatory loopholes and weaknesses in the food and drug safety field discovered in the handling of cases, supervise the supervision departments to perform their duties in accordance with the law, and jointly improve the food and drug safety governance system.

Question 2: How do the three departments cooperate and strengthen cooperation in protecting food and drug safety?

Answer: Our three departments took this special action as an opportunity to communicate and cooperate closely, and work together to maintain food and drug safety. One is to strengthen communication and information sharing. The Supreme People’s Procuratorate, the State Administration for Market Supervision and Administration, and the State Drug Administration conduct seminars on key cases, jointly observe court trials, exchange personnel for job exchanges, and provide mutual support for business training. The Supreme People’s Procuratorate invited the Supreme People’s Court, the State Administration of Market Supervision and Administration, and the China Consumers Association to hold a symposium to reach a preliminary consensus on advancing the establishment of a punitive damages system. Local market supervision departments and drug supervision departments take the initiative to invite procuratorial agencies to participate in food and drug safety inspections and other law enforcement activities, promptly report the progress of administrative investigations of cases and the status of transfers to public security, jointly study and handle difficult and complicated cases, realize information exchange and sharing, and form a joint force of law enforcement and justice . The second is to jointly carry out characteristic "small special projects". In response to key areas and regions with greater local food and drug safety risks, all localities have used "small special projects" as the entry point and breakthrough point to promote the in-depth implementation of special actions to implement the "four most stringent" requirements. For example, procuratorial organs in many places have jointly conducted special inspections of food safety on campuses and surrounding areas with market supervision, education, and health and epidemic prevention departments, actively implementing national epidemic prevention and control requirements, and effectively ensuring the health of teachers and students. The third is to work together to promote the formulation and improvement of relevant laws and regulations. Combined with the revision of the scope of counterfeit and inferior drugs in the "Drug Administration Law," we will jointly study and improve relevant laws and regulations to punish drug safety crimes, help the State Drug Administration to issue approvals on the identification of counterfeit and inferior drugs, and propose relevant provisions of the Criminal Law Amendment (11) opinion. In response to the outstanding issues that need to be resolved in criminal food-related cases in judicial practice, the Supreme People’s Court and the Supreme People’s Procuratorate are jointly revising the "Interpretation on Several Issues Concerning the Application of Laws in Handling Criminal Cases Endangering Food Safety", and the State Administration for Market Regulation and others are actively participating in the research. Jointly combine case handling practices and the needs of people's livelihood, and rationally design rules. The fourth is to further establish and improve a long-term mechanism for the connection between administrative law enforcement and criminal justice. Relevant functional departments are studying and formulating the "Measures for the Connection between Market Supervision and Administration Administrative Law Enforcement and Criminal Justice" and "Measures for the Connection between Administrative Law Enforcement and Criminal Justice in the Field of Agricultural Product Quality and Safety". The promulgation of these documents will further straighten out the "two-law convergence" mechanism and promote All functional departments fully consolidate their work and work together to expand the effectiveness of their work. Procuratorial agencies in many places and relevant administrative supervision departments have jointly formulated specific implementation rules and supporting regulations for the "two-law convergence" to ensure the effective operation of the convergence mechanism.

Question 3: During the prevention and control of the new crown epidemic, what response measures have the three departments taken?

Answer: During the prevention and control of the new crown pneumonia epidemic, we will closely focus on the overall situation of the epidemic prevention and control work, play a functional role, and severely crack down on illegal and criminal activities such as counterfeit and inferior protective products, counterfeit and inferior drugs, and make every effort to ensure the quality of epidemic prevention and control drugs and medical devices. Safety. The State Administration of Market Supervision and Administration has stepped up its supervision and law enforcement, and gave full play to the role of the platform of “guarantee price, quality, and supply” to ensure stable prices, safe quality, and sufficient supply of all kinds of epidemic prevention supplies and residents’ daily necessities, in order to prevent and control the epidemic Escort the deterrence battle; use case listing supervision as a starting point, continue to explore and establish a coordination mechanism for major case reports and case investigations, continue to deepen the coordination and linkage of law enforcement and case handling, and actively do a good job in the supervision of case investigations, and deal with 42 cases of high value and illegal circumstances. Cases with heavy social impact were listed for supervision, and the food cases such as "Burger King" that were exposed at the March 15 party were organized to investigate. The relevant stores and persons responsible for the case have been punished with administrative penalties such as revoking the administrative license, confiscating illegal income, and fines. The National Medical Products Administration organizes the centralized rectification of medicinal equipment for epidemic prevention and control, actively promotes the development and marketing of new coronavirus vaccines, does a good job of emergency approval of new coronary pneumonia treatment drugs and medical protective medical devices, actively connects with relevant manufacturers, and completes registration inspection and review. Prepare for the large-scale production of the new coronavirus vaccine. And strictly control the quality, strengthen risk management, and send supervision teams to key provinces to supervise the quality of medical supplies. At present, a total of 22 drugs have been urgently approved to carry out clinical trials for the treatment and prevention of new coronary pneumonia and its related indications; 2 drugs have been approved for listing with conditions; 54 new coronavirus detection reagents have been urgently approved, with a daily production capacity of 24.018 million copies. 420 registration certificates for medical protective clothing and 307 registration certificates for medical protective masks were approved by various localities. Conditional approval of 2 new coronavirus vaccines in my country has been made, and 5 technical routes have been approved for clinical trials of 16 vaccine varieties in emergency, of which 6 vaccine varieties have started phase III clinical trials. The Supreme People’s Procuratorate has strengthened research and grasped the characteristics of criminal laws in response to the fact that the production and sale of counterfeit and inferior prevention, protective equipment, and substandard medical equipment and other illegal and criminal cases during the epidemic prevention and control period are frequently occurring, and the Supreme People’s Court, the Ministry of Public Security, and the Ministry of Justice should be coordinated in a timely manner. Promulgated the "Opinions on Punishment of Illegal Crimes Obstructing the Prevention and Control of the Novel Coronavirus Infection Pneumonia Epidemic", and actively responded to the case of manufacturing and selling fake and inferior masks by answering questions from reporters through the "two highs" method. How to accurately grasp the case certification standards and accurately apply the crimes, etc. problem. Publish multiple batches of typical cases, organize a line of training, clarify the standards for handling crimes involving epidemics, unify the understanding, achieve precise strikes, and prevent and control in accordance with the law. In 2020, the procuratorial organs handled a batch of crimes involving the prevention and control of the production and sale of counterfeit and substandard goods, intervened in the investigation of 682 such cases, approved 400 arrests of 683 people, prosecuted 451 cases, 959 people, and the first instance has effective judgments on 225 cases and 404 people. Supervised the public security organs to file 61 cases with 77 people. Local procuratorial organs give full play to the role of procuratorial functions, and closely integrate law-based crime suppression with epidemic prevention and control, resumption of work and production, and maintenance of market economic order, effectively protecting the lives and health of the people, and maintaining the stability of market economic order.

Question 4: What are the considerations for the release of these typical cases?

A: Through the joint efforts of all parties, the overall food and drug safety situation has improved in recent years, but criminal cases that endanger food and drug safety still occur from time to time, bringing serious harm and huge hidden dangers to the health of the people. This time, we have screened 15 typical cases of administrative, criminal, and public interest litigation for cases that are prone to occur frequently in law enforcement and judicial practice, combined with the results of special actions, covering a wide range of areas, including meat products from overseas epidemic areas and the addition of prohibited substances. Cases in the food sector such as diet coffee and health food products, “poisonous brewed skins” and “fake roast ducks”, cooked foods that altered the production date, and non-performance of online ordering platforms. There are also black workshops producing and selling counterfeit drugs, and pharmacies selling expired and inferior drugs. There are also cases of substandard cosmetics and cases of fake and inferior seeds that endanger agricultural safety. Some are sold in traditional physical stores, some organize sales teams to promote large-scale sales, and some are widely sold through the Internet, which is very harmful.

For example, in the case of Shanghai Han XX and Hong XX producing and selling toxic and harmful foods, Han XX and Hong XX mixed sibutramine, which is prohibited by the state, into weight-loss coffee and sold them on a large scale online, with a sales amount of 800 More than 10,000 yuan, endangering the physical and mental health of many online consumers. Consumers are reminded to raise awareness of prevention, understand the hazards of "sibutramine" coffee and the identification method, and achieve scientific weight reduction. Another example is the crime of Jilin Sun and others producing and selling toxic and harmful food. Sun and others used different packaging to produce health food in small workshops without obtaining relevant production licenses, adding western medicine ingredients at will, and selling them. The quantity reached more than 1,400 boxes, which severely disrupted the health food market order and endangered the health of consumers. To guide consumers to establish the concepts of healthy consumption and safe consumption, the administrative law enforcement departments should also strengthen supervision and standardize the order of the health food market. Another example is the case of Anhui Li and others manufacturing and selling counterfeit medicines. Li and others produced fake "benazepril hydrochloride tablets" and "aspirin enteric-coated tablets" in black workshops and sold them to many places for production and sales. The total amount is more than 3 million yuan, which directly endangers the life, health and safety of patients with cardiovascular and cerebrovascular diseases, and causes great social harm. It is reminded that the general public should pay attention to drug safety, purchase drugs from formal channels and check whether there is any abnormality in drug packaging and quality.

The cases released this time are all around the people and are closely related to the people’s vital interests. On the one hand, it demonstrates our clear attitude and firm determination to actively safeguard the people’s personal and property safety, effectively deterring criminals, and on the other hand can also remind People who encounter similar situations in social life should raise their awareness of prevention and beware of being deceived. At the same time, these cases also involve the effective connection of administrative law enforcement and criminal justice, the distinction between this crime and the other crime, and the protection of the people's legitimate rights and interests through public interest litigation. They also have a certain exemplary and guiding role for local law enforcement and case handling departments.

Question 5: What are the next steps in protecting food and drug safety?

Answer: We will continue to strictly abide by the bottom line of food and drug safety, maintain unabated efforts to crack down on crimes that endanger food and drug safety, pay close attention to investigations and handle cases, and improve the governance system, which will indeed enhance the people's sense of gain, happiness, and security.

The first is to further implement the "four most stringent" requirements, highlight key areas, focus on the "three no foods", "expired foods", and "uninspected and quarantined foods" and other issues, severely crack down on illegal crimes in the production and sale of counterfeit and inferior foods in rural areas, and earnestly safeguard rural areas. food safety. Intensify the crackdown on the crimes of producing and selling counterfeit and inferior seeds, pesticides, fertilizers and other agricultural materials in accordance with the law, and earnestly safeguard national food security. Vigorously punish illegal additions, false propaganda and crimes in the field of health food to meet the people's health needs. Properly handle epidemic-related cases in accordance with the law, accurately punish the production and sale of counterfeit and inferior prevention and control, protective products, drugs, and cold-chain foods of unknown origin illegal crimes, pay close attention to production, sales, and transportation links, actively promote the supervision of key epidemic prevention products such as vaccines, and strengthen forward-looking analysis Study and judge and punish criminal acts in accordance with the law. In-depth implementation of online drug and cosmetics sales of illegal drugs and cosmetics "online net and offline clean source" special rectification to maintain the safety of online consumption of drugs and cosmetics. The second is to further improve the normalized communication and coordination mechanism, enhance supervision coordination, and promote the formulation and promulgation of relevant market supervision, agricultural product safety administrative law enforcement and criminal justice linkage work measures, and enhance the combined force of crackdowns. The third is to strengthen the research of the problem and integrate the criminal law