National Medical Products Administration announced the fourth batch of typical cases of drug safety special rectification.

National Medical Products Administration announces the fourth batch of typical cases of drug safety special rectification. Since the beginning of 2022, in order to implement the decision-making arrangements of the CPC Central Committee and the State Council on strengthening drug safety, National Medical Products Administration has organized nationwide drug safety special rectification actions with strict investigation of illegal activities and strict control of risks as the main line. Local drug regulatory authorities continued to strengthen supervision and law enforcement, severely cracked down on illegal acts endangering drug safety, investigated and dealt with a number of illegal cases, and earnestly safeguarded people’s health and drug safety. The fourth batch of typical cases of drug safety special rectification is now announced. I. Hao Cheng Oxygen Factory in Tieling Economic Development Zone failed to comply with good manufacturing practice’s case in drug production activities [Brief Introduction to the case] In March 2022, Liaoning Drug Administration found in its daily supervision and inspection that Hao Cheng Oxygen Factory in Tieling Economic Development Zone had a serious violation of the good manufacturing practice. After investigation, the company’s quality management system is not perfect, and there are behaviors such as production, inspection, inspection and recheck that are not in accordance with the regulations, and the person in charge of the enterprise, the person in charge of production management and the quality authorized person fail to perform the corresponding management duties. The above-mentioned behavior of the company violated the first paragraph of Article 43 of the Drug Administration Law and the sixth paragraph of Article 69 of the Measures for the Supervision and Administration of Drug Production. In August 2022, Liaoning Drug Administration ordered the company to suspend production and business for rectification in accordance with Article 126 of the Drug Administration Law and Articles 4, 6 and 9 of the Provisions on the Application of Administrative Punishment Discretion of Liaoning Food and Drug Administration.An administrative penalty of 100,000 yuan will be imposed, and the legal representative, the person in charge of production management and the quality authorized person of the company will be given an administrative penalty of confiscation of income and fines from their own units during the illegal act. [Typical significance] Oxygen is the key substance for human metabolism. Medical oxygen is mainly used for oxygen inhalation in patients with hypoxia in clinic, especially in emergency situations. High-purity oxygen can be used to save patients’ lives. China has strict requirements on the production management, quality control, storage and release of medical oxygen. In this case, the key personnel of the enterprise failed to perform the corresponding management responsibilities, and the enterprise did not comply with the good manufacturing practice to organize production, so the product quality was difficult to guarantee, which brought potential hidden dangers to the public’s safe and effective drug use. The drug regulatory authorities conscientiously implement the requirements of the "double punishment system", and at the same time, impose corresponding administrative penalties on the relevant responsible personnel of the enterprise according to law, which is of great significance to urge enterprises to implement the main responsibility and compact the post responsibilities of relevant employees. II. Case of Wei Motao’s Illegal Acquisition of Drugs [Brief Introduction to the Case] In December 2021, the Fengtai District Market Supervision Administration of Beijing and the Fengtai Branch of the Beijing Municipal Public Security Bureau jointly inspected and found that Wei Motao bought drugs such as Niaoduqing granules and acarbose tablets from individuals around Fengtai District through cash transactions and on-the-spot settlement. Wei Motao’s above behavior violated the provisions of Article 22 of the Measures for the Supervision and Administration of Drug Circulation. In August 2022,According to Article 115 of the Drug Administration Law, Item 1 and Item 4 of Article 17 of the Provisions of Beijing Food and Drug Administration on the Application of Administrative Punishment Discretion (Trial) and Item 3 of Article 152 of Beijing Drug Administration Discretion Benchmark (Trial), Beijing Fengtai Market Supervision Administration imposed an administrative penalty on the party concerned, which included confiscation of the drugs involved and a fine of 1.6 million yuan. [Typical Significance] China implements a strict licensing system for drug business activities, and illegal acquisition of drugs is prohibited. In this case, criminals used the price difference between the purchased medical insurance drugs and the drugs sold normally to obtain high profits, which not only seriously disrupted the order of drug management, but also caused the illegal purchase of drugs to be out of formal management, and the storage conditions of drugs could not be guaranteed, and the related drugs were re-circulated to patients, which brought great hidden dangers to the public’s drug safety. Strict investigation and punishment by drug regulatory authorities in accordance with the law has a positive demonstration role in effectively curbing related illegal activities, which is conducive to standardizing the order of drug circulation and effectively ensuring the safety of people’s medication. Iii. Case of Kangjian Store of Shi ‘antang Pharmaceutical Chain Co., Ltd. in Jining City [Brief Introduction to the Case] In 2021, Jining Municipal Market Supervision Administration of Shandong Province and Qufu Municipal Market Supervision Administration jointly inspected and sampled Kangjian Store of Shi ‘antang Pharmaceutical Chain Co., Ltd. in Jining City within the jurisdiction of Qufu City, and found that the drugs sold in this store, such as "Special Effects on Muscular Pain" and "Pain Eliminating Roots", contained diclofenac sodium and other ingredients and were identified as counterfeit drugs.Qufu Municipal Market Supervision Administration transferred the case to Qufu Municipal Public Security Bureau for investigation. In June 2022, the People’s Court of Qufu City, Shandong Province convicted the person in charge of the store of selling counterfeit drugs, sentenced him to criminal detention and fined him. In October, 2022, according to Articles 116 and 118 of the Drug Administration Law, Jining Municipal Market Supervision Administration imposed an administrative penalty on the store to revoke its Drug Business License, and imposed an administrative penalty on the person in charge of the store to ban drug production and business activities for life. [Typical Significance] As a special commodity for treating diseases and saving lives, the quality and safety of drugs are directly related to the public’s health and life safety. We must strictly guard against and strictly control the drug safety risks, and resolutely prevent and eliminate the damage caused by counterfeit and inferior drugs to people’s lives and health. The parties in this case sell fake drugs, which is extremely harmful to society. The judicial organs sentenced the relevant responsible persons to criminal detention and fined them according to law, and the drug regulatory authorities imposed administrative penalties on the parties concerned and banned the relevant responsible persons according to law, which reflected the determination to resolutely implement the "four strictest" requirements for drug safety. This case is a typical case of execution linkage between the drug regulatory authorities and the public security and judicial departments, which embodies a good working mechanism of information exchange and close cooperation between the administrative departments and the public security and judicial departments, and reflects the efficient law enforcement joint force of execution convergence, which has reference significance for the drug regulatory authorities at all levels and the public security and judicial departments to share information and jointly crack down on illegal acts.IV. Case of Guangzhou Dameikang Medical Device Co., Ltd. Failing to fulfill the obligation of registered agent [Brief Introduction to the case] According to the case clue assigned by National Medical Products Administration, in June 2022, Guangdong Provincial Drug Administration filed an investigation on Guangzhou Dameikang Medical Device Co., Ltd. for allegedly failing to fulfill the obligation of registered agent of overseas medical devices. Upon investigation, the party concerned, as the import registration agent of medical devices, failed to fulfill the obligation to inform the registrant of the need to supplement the notarized letter of ISO certificate, product label and authenticity statement for the change of production address during the process of assisting the registrant to apply for the registration of imported medical devices in National Medical Products Administration, and Yin Moumou, the registration Commissioner of the party concerned, forged a false notarized letter through photo editing software without authorization and submitted it to National Medical Products Administration as registration correction materials. In November 2021, the parties have assisted the registrant to apply for withdrawing the application for registration of medical devices involved. The above-mentioned behavior of the parties violates the provisions of Paragraph 4 of Article 14, Paragraph 5 and Paragraph 2 of Paragraph 1 of Article 20 of the Regulations on the Supervision and Administration of Medical Devices (Order No.739 of the State Council). In August, 2022, Guangdong Drug Administration ordered the parties concerned to correct the above-mentioned illegal acts according to the first paragraph of Article 98 of the Regulations on the Supervision and Administration of Medical Devices (the State Council Order No.739), and imposed an administrative penalty of a fine of 120,000 yuan on the parties concerned, and imposed an administrative penalty of banning the production and operation of medical devices for five years on its responsible person Yin Moumou.[Typical Significance] Applicants for medical device registration should ensure that the submitted materials are legal, true, accurate, complete and traceable. An overseas applicant shall designate an enterprise legal person in China as an agent to handle the relevant medical device registration matters. The agent shall assist the registrant to fulfill the legal obligations according to law, and assist the overseas registrant to fulfill the corresponding legal responsibilities. Since the launch of the special rectification campaign for drug safety, drug regulatory authorities at all levels have severely cracked down on the fraudulent registration of medical devices. This case is the first case of fraudulent registration of medical devices involving medical device agents. Guangdong Provincial Drug Administration has imposed administrative penalties on the parties who are fined and the responsible personnel who are forbidden to engage in the production and business activities of medical devices for five years, investigated the legal responsibilities of the parties according to law, and strictly implemented the punishment for illegal acts to meet the requirements of people, thus forming a powerful deterrent, which is conducive to standardizing the registration behavior of medical devices and ensuring the safety and effectiveness of medical devices. V. Case of Ningbo Jingbo Rehabilitation Aids Co., Ltd. producing Class II medical devices without permission [Brief Introduction to the case] On March 4, 2022, Ningbo Municipal Market Supervision Administration of Zhejiang Province inspected Ningbo Jingbo Rehabilitation Aids Co., Ltd. After investigation, the party involved was suspected of producing scoliosis orthosis without permission, which was not registered according to law. The value of the goods involved was 264,000 yuan, and the illegal income was 264,000 yuan. The parties’ unauthorized production of Class II medical devices that are not registered according to law violates the Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.739? Number)Paragraph 1 of Article 16 and paragraph 1 of Article 32 stipulate that. On August 3, 2022, Ningbo Municipal Market Supervision Administration issued the Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.739? No.) Items 1 and 2 of the first paragraph of Article 81 and the Guiding Opinions on Standardizing the Discretion of Administrative Punishment in Market Supervision and Management (Guo Shi Jian Law [2019] No.244) stipulate that it is decided to give the parties a mitigated punishment, and impose an administrative penalty of confiscation of illegal income of 264,000 yuan and a fine of 1.32 million yuan. [Typical Significance] With the development of economy and society, rehabilitation therapy has become a new growth point in the medical field. Adolescent idiopathic scoliosis occurs frequently, and its treatment process and the legality of medical devices used have also become the focus of people’s attention. During the investigation and handling of the case, the supervision department deeply understood the causes, diagnosis points, treatment methods and imaging features of scoliosis, and extracted the electronic data of patients’ radiation images from PACS system by using technical methods, so as to find the breakthrough direction of case handling, thus uncovering the hidden rules of unlicensed production of medical devices in the field of medical rehabilitation and infringing on patients’ rights and interests. The handling of this case highlights the determination of the drug regulatory authorities to make key breakthroughs and overcome difficulties in the light of new illegal acts of medical devices, maintains the order of production and use of medical devices, and effectively guarantees the safety of public equipment. VI. Suzhou Weishijian Medical Instruments and Equipment Import and Export Co., Ltd. operates unregistered Class III medical devices and medical devices without Chinese instructions and labels [Brief Introduction] In June 2022,Law enforcement officers of gusu district Market Supervision Administration in Suzhou, Jiangsu Province inspected Suzhou Weishijian Medical Instruments and Equipment Import and Export Co., Ltd. according to the investigation clues. After investigation, the parties involved were suspected of operating unregistered imported medical devices such as intraocular lighting probes and ultra-emulsion wave cutting machines without Chinese instructions and labels, involving a value of 20,988.73 yuan. The parties’ operation of unregistered Class III medical devices and medical devices without Chinese instructions and labels violates the Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.739? Number) the provisions of the first paragraph of article thirty-ninth, second paragraph third and fifty-fifth. In September, 2022, the gusu district Municipal Market Supervision Administration of Suzhou City issued the Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.739? ) Article 88 (2), Article 81 (1) and Article 13 (1) of the Provisions on the Application of Administrative Punishment Discretion in Suzhou Market Supervision and Management (Trial) stipulate that the parties concerned shall be given a lighter punishment, and they shall be given an administrative penalty of confiscation of illegal income, confiscation of 104 unlicensed medical devices and a fine of 358,819.68 yuan. 【 Typical 】 According to the Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.739th? No.) Article 55 stipulates that medical device trading enterprises and users shall not operate or use medical devices that are not registered or filed according to law, have no certificates, or are expired, invalid or eliminated. At present, ophthalmic surgery technology is developing rapidly, the market competition is fierce, and some medical device business units have a weak sense of main responsibility. In order to gain a competitive advantage,Without authorization, unregistered medical devices (mostly consumable parts) are put into the market, resulting in unlicensed operation and use of medical devices. The investigation and handling of this case made medical device enterprises and users understand the importance of legal operation, which played a positive role in protecting consumers’ rights and purifying the market environment. VII. Case of Guangzhou Henglan Biotechnology Co., Ltd. Using Cosmetic Prohibited Raw Materials to Produce Cosmetics [Brief Introduction to the Case] In March 2022, Guangdong Drug Administration comprehensively analyzed and judged the clues of the case, and jointly conducted a surprise inspection on Guangzhou Henglan Biotechnology Co., Ltd. with the public security organs, and sampled some cosmetics. After investigation, the baby Beixuan baby skin cream and baby Kang Yishengyuan body milk produced by the company from November 2021 to March 2022 were found to contain clobetasol propionate, halobetasol propionate and cyproheptadine, the value of which was 212,667 yuan. Guangdong Drug Administration transferred the case to the public security organ according to law, and the public security organ has filed a case for investigation according to law. At the same time, in view of the fact that the products involved are children’s cosmetics, and the illegal acts are serious, in October 2022, Guangdong Provincial Drug Administration imposed administrative penalties on the company’s use of prohibited raw materials to produce cosmetics, in accordance with Article 59, paragraph 3, of the Regulations on Cosmetics Supervision and Administration, such as revoking its cosmetics production license, canceling its cosmetics product filing, not handling its cosmetics filing within 10 years and accepting its cosmetics administrative license application.Wu Moumou, the legal representative of the company, and Mo Moumou, the person in charge of production, were given an administrative penalty prohibiting them from engaging in cosmetics production and business activities for life. [Typical Significance] Using prohibited raw materials for cosmetics to produce children’s cosmetics or illegally adding substances that may endanger human health in children’s cosmetics is a serious case as stipulated in Article 61 of the Measures for the Supervision and Administration of Cosmetic Production and Operation, and such illegal acts should be severely punished according to law. In this case, the drug supervision and administration department took the initiative to dig deep into the clues of the case source, unblocked the green channel of product inspection involved, deepened the convergence of case execution, and jointly cracked down on the illegal addition of children’s cosmetics with the public security organs. The pharmaceutical supervisory and administrative department shall, in accordance with the law, punish the enterprises involved in the case by revoking their cosmetics production licenses and canceling their product records, and give the legal representative of the enterprises involved a life-long ban on business, and for the first time, give the person in charge of the production of the enterprises involved a life-long ban on business, which has formed a powerful shock to the lawless elements and reflected the firm determination of the supervisory department to resolutely protect the safety of children’s cosmetics. Eight, "5 7" Jiangsu Yangzhou production and sales of counterfeit cosmetics case [Brief Introduction] On September 15, 2022, the Guangling District People’s Court of Yangzhou City, Jiangsu Province sentenced Zhang Moumou and other eight criminals who produced and sold counterfeit cosmetics to fixed-term imprisonment ranging from three years to one year, plus a fine. The discovery of this case originated from the illegal clues found by Yangzhou Inspection Branch of Jiangsu Drug Administration in the cosmetic safety risk monitoring work.After discovering the illegal clues of counterfeit cosmetics mentioned above, Yangzhou Inspection Branch immediately set up a joint task force with Yangzhou Public Security Bureau’s Food and Drug Environmental Investigation Detachment, persisted in tracing the source and digging deep along the line, and finally destroyed a counterfeit cosmetics production den and two hose suppliers, and arrested many suspects such as Zhang Moumou. After investigation, since March, 2020, Zhang Moumou and others have purchased components such as paste, imitation packaging materials, trademarks and anti-counterfeiting labels, processed and assembled counterfeit cosmetics by themselves, and sold them through the Internet. [Typical Significance] In recent years, criminals aim at brand cosmetics to make and sell fakes, and seek illegal benefits by relying on the high-quality brand effect of others. In this case, the drug supervision and administration department attaches great importance to the illegal clues found in the safety risk monitoring of cosmetics in Conghua, gives full play to its professional and technical advantages, and cooperates with the public security organs. Under the framework of the working mechanism of "counterfeiting and protecting famous brands", the administrative law enforcement departments, the public security organs, the judicial organs and the obligee enterprises work together to wipe out the chain of counterfeiting and selling, effectively protect the safety of public cosmetics, maintain fair competition market order and create a good business environment. IX. "6 12" Case of Selling Counterfeit Cosmetics in Zhangzhou, Fujian [Brief Introduction to the Case] In September 2021, Zhangzhou Municipal Market Supervision Administration of Fujian Province received many complaints and reports, reflecting that the registered address was in many Taobao shops in Zhao ‘an County, Zhangzhou City, selling counterfeit brand cosmetics. Zhangzhou Municipal Market Supervision Administration immediately organized an investigation. After comprehensive judgment, Zhao ‘an County Market Supervision Administration transferred the clue to the public security organ.At the same time, Zhangzhou city and county market supervision and public security departments set up a joint task force to jointly investigate the case. In June 2022, the joint task force sent more than 100 law enforcement officers to Shenzhen, Guangdong, Dalian, Liaoning, Handan, Hebei, Zhangzhou, Fujian and other places to carry out the network-closing operation at the same time, destroying 6 dens for selling fake cosmetics in one fell swoop, arresting 73 people involved on the spot and seizing a large number of counterfeit cosmetics. Up to now, Zhao ‘an County People’s Procuratorate has approved the arrest of three major suspects in this case, transferred three people for review and prosecution, and 21 other suspects have been released on bail pending trial. The case is under further investigation. [Typical Significance] In recent years, with the increasing crackdown on cosmetic crimes, cosmetic counterfeiting dens have been further transferred to remote areas such as rural areas and urban-rural junctions. In this case, criminals formed gangs to commit crimes, and they were scattered in remote areas such as rural areas in Fujian and Guangdong, and they had a strong sense of anti-investigation. They opened a number of online stores on multiple e-commerce platforms to produce and sell illegal cosmetics across provinces. Through careful investigation of illegal clues and close cooperation with public security organs, the drug supervision and administration department found out the context of illegal acts in the whole case, and finally successfully destroyed the black dens and safeguarded the safety of public makeup.