China News Service, January 16. According to news from the official website of the State Food and Drug Administration on the 16th, since the beginning of 2022, the State Food and Drug Administration has focused on strictly investigating violations of laws and strictly controlling risks, and has organized and carried out special rectification actions on drug safety across the country.
The drug regulatory authorities in various places continue to increase supervision and law enforcement, severely crack down on illegal activities that endanger drug safety, investigate and deal with a number of violations of laws and regulations, and earnestly safeguard the health of the people and drug safety.
The fourth batch of typical cases of drug safety special rectification is hereby announced.
1. The case of Chenghao Oxygen Factory in Tieling Economic Development Zone engaged in drug production activities not complying with the Good Manufacturing Practice for Drugs
[Case Brief] In March 2022, the Liaoning Provincial Drug Administration discovered during its daily supervision and inspection that the Chenghao Oxygen Plant in Tieling Economic Development Zone had seriously violated the "Good Manufacturing Practice for Drugs".
After investigation, the company's quality management system was not sound, and there were behaviors such as production, inspection, inspection, and review that did not follow the regulations, and the person in charge of the enterprise, the person in charge of production management, and the quality authorized person failed to perform corresponding management duties.
The company's above-mentioned behavior violated the first paragraph of Article 43 of the "Drug Administration Law" and the sixth item of Article 69 of the "Measures for the Supervision and Administration of Drug Production".
In August 2022, the Liaoning Provincial Drug Administration, in accordance with Article 126 of the "Drug Administration Law" and Articles 4, 6 and 9 of the "Applicable Provisions on Administrative Punishment Discretion of the Liaoning Provincial Drug Administration" , the company was ordered to suspend production and business for rectification, and an administrative penalty of 100,000 yuan was imposed, and the company's legal representative, person in charge of production management, and quality authorized person were respectively imposed on confiscation of the income and fines obtained from the unit during the illegal act. Administrative penalties.
[Typical Significance] Oxygen is a key substance for the human body to carry out metabolism. Medical oxygen is mainly used for inhaling oxygen for hypoxic patients in clinical practice. Especially in emergency situations, high-purity oxygen can be used to save the lives of patients.
my country 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 duties, and the enterprise failed to comply with the "Good Manufacturing Practice for Drugs" to organize production, which made it difficult to guarantee product quality and brought potential hidden dangers to the safety and effectiveness of drug use by the public.
The drug regulatory department conscientiously implements the requirements of the "double penalty system". While investigating and punishing enterprises according to law, it also imposes corresponding administrative penalties on relevant responsible personnel of enterprises according to law.
2. Wei Moutao's illegal purchase of drugs
[Introduction to the case] In December 2021, the Beijing Fengtai District Market Supervision Administration and the Fengtai Branch of the Beijing Municipal Public Security Bureau jointly inspected and found that Wei Moutao had not obtained the "Drug Business License" and was in Fengtai through cash transactions and on-the-spot settlement. Purchase Niaoduqing Granules, Acarbose Tablets and other drugs from individuals around the district.
Wei Moutao's above-mentioned behavior violated the provisions of Article 22 of the "Measures for the Supervision and Administration of Drug Circulation".
In August 2022, Beijing Municipal Fengtai District Market Supervision and Administration Bureau, in accordance with Article 115 of the "Drug Administration Law" and Article 17, Item 1 of the "Regulations on the Application of Administrative Punishment Discretion Power of Beijing Municipal Food and Drug Administration (Trial)" , Item 4, and Paragraph 3 of Article 152 of the "Beijing Municipal Drug Supervision Administrative Punishment Standards (Trial)" stipulates that the party concerned shall be imposed an administrative penalty of confiscation of the drugs involved in the case and a fine of 1.6 million yuan.
[Typical Significance] my country implements a strict licensing system for pharmaceutical business activities, and prohibits the illegal purchase of pharmaceuticals.
In this case, criminals planned to obtain high profits by taking advantage of the price difference between purchased medical insurance drugs and normal sales drugs. And then circulated to the hands of patients, which will bring great hidden danger to the safety of public medication.
The strict investigation and punishment by the drug regulatory department in accordance with the law has a positive demonstration effect on effectively curbing relevant illegal activities, which is conducive to standardizing the order of drug circulation and effectively ensuring the safety of people's medication.
3. The case of selling counterfeit medicines at the Kangjian store of Jining Shiantang Pharmaceutical Chain Co., Ltd.
[Introduction to the case] In 2021, Jining City Market Supervision Administration and Qufu Market Supervision Administration jointly inspected and sampled the health store of Jining Shi'antang Pharmaceutical Chain Co., Ltd. within the jurisdiction of Qufu City, and found that the store sold Drugs labeled as "Special Muscle and Bone Pain" and "Pain Elimination" contain ingredients such as diclofenac sodium, which were identified as counterfeit drugs.
The Qufu Municipal Market Supervision Administration transferred the case to the Qufu Municipal Public Security Bureau for investigation.
In June 2022, the People's Court of Qufu City, Shandong Province sentenced the person in charge of the store to the crime of selling counterfeit medicines, sentenced him to criminal detention and fined him.
In October 2022, the Jining City Market Supervision Administration imposed an administrative penalty on the store to revoke the "Drug Business License" in accordance with Articles 116 and 118 of the "Drug Administration Law". The person in charge of the store shall be imposed an administrative penalty of being banned from engaging in drug production and business activities for life.
[Typical Significance] As a special commodity for treating diseases and saving lives, the quality and safety of medicines are directly related to public health and life safety. It is necessary to strictly prevent and control drug safety risks, and resolutely prevent and eliminate counterfeit and inferior medicines from harming the lives and health of the people.
The parties in this case sold counterfeit medicines, causing great social harm.
The judiciary has sentenced the responsible persons to criminal detention and imposed fines in accordance with the law, and the drug regulatory department has imposed administrative punishments such as revoking the licenses of the parties concerned and banning the relevant responsible persons according to the law, reflecting 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 department and the public security and judicial department. It reflects the good working mechanism of information exchange and close cooperation between the administrative department and the public security and judicial department. Judicial departments share information and jointly crack down on violations of laws and regulations, which are of reference significance.
4. The case of Guangzhou Dameikang Medical Devices Co., Ltd. failing to perform its obligations as a registered agent
[Introduction to the case] According to the clues of the case assigned by the State Food and Drug Administration, in June 2022, the Guangdong Provincial Drug Administration filed a case for investigation into the suspected failure of Guangzhou Dameikang Medical Devices Co., Ltd. to fulfill its obligations as an overseas medical device registration agent. .
After investigation, the party concerned, as the import registration agent of medical devices, failed to inform the registrant to supplement the ISO certificate, product label and authentic Yin Moumou, the registration commissioner of the party, forged a false notarization letter through picture editing software without authorization and submitted it to the State Food and Drug Administration as registration supplementary materials.
In November 2021, the parties have assisted the registrant in applying to withdraw the application for registration of the medical device involved in the case.
The above-mentioned behavior of the parties violated the provisions of Article 14, Paragraph 4, Article 20, Paragraph 1, Paragraph 5, and Paragraph 2 of the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739).
In August 2022, the Guangdong Provincial Drug Administration ordered the party concerned to correct the above-mentioned illegal acts in accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739), and imposed a fine of 120,000 yuan on the party concerned. The person in charge, Yin, was given an administrative penalty of being prohibited from engaging in medical device production and business activities within 5 years.
[Typical Significance] Applicants for medical device registration shall ensure that the submitted materials are legal, authentic, accurate, complete and traceable.
Overseas applicants should designate an enterprise legal person in China as an agent to handle relevant medical device registration matters.
The agent shall assist the registrant in fulfilling its statutory obligations in accordance with the law, and assist the overseas registrant in fulfilling its corresponding legal responsibilities.
Since the launch of the special rectification campaign on drug safety, drug regulatory authorities at all levels have severely cracked down on falsification of medical device registration and filing. This case is the first successfully investigated case of falsification of medical device registration data involving a medical device agent.
The Guangdong Provincial Food and Drug Administration imposed fines on the parties and administrative penalties for the responsible personnel to be prohibited from engaging in the production and operation of medical devices within 5 years. Registration acts to ensure the safety and effectiveness of medical devices.
5. Ningbo Jingbo Rehabilitation Aids Co., Ltd. unlicensed production of Class II medical devices that have not been legally registered
[Case Brief] On March 4, 2022, the Market Supervision and Administration Bureau of Ningbo City, Zhejiang Province inspected Ningbo Jingbo Rehabilitation Aids Co., Ltd.
After investigation, the party involved was suspected of producing unlicensed scoliosis orthotics that were not legally registered. The value of the goods involved in the case was 264,000 yuan, and the illegal income was 264,000 yuan.
The behavior of the party concerned to produce Class II medical devices that have not been registered in accordance with the law violates the first paragraph of Article 16 and the first paragraph of Article 32 of the "Regulations on the Supervision and Administration of Medical Devices" (Decree No. 739 of the State Council) .
On August 3, 2022, the Ningbo Market Supervision and Administration Bureau, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. The Guiding Opinions on the Discretionary Power of Administrative Punishment (Guoshijianfa [2019] No. 244) stipulates that it is decided to give the party a reduced punishment, confiscating 264,000 yuan of illegal income and imposing an administrative penalty of 1.32 million yuan in fines.
[Typical Significance] With the development of economy and society, rehabilitation therapy has become a new growth point in the medical field.
The incidence of adolescent idiopathic scoliosis is high, and the treatment process and the legality of the medical equipment used have also become a hot spot of concern to the people.
During the investigation and handling of the case, the supervisory department had a deep understanding of the causes of scoliosis, key points of diagnosis, treatment methods, and imaging features, and used technical methods to extract the patient's radiological image electronic data from the PACS system to find out the direction of breakthrough in case handling, thereby revealing the Undocumented unlicensed production of medical devices that have not been legally registered in the field of medical rehabilitation and infringe on the rights and interests of patients.
The handling of this case demonstrates the determination of the drug regulatory authorities to make key breakthroughs and overcome difficulties in response to new medical device violations, maintain the production and use order of medical devices, and effectively guarantee the safety of public devices.
6. The case of Suzhou Weishijian Medical Equipment Import and Export Co., Ltd. operating unregistered third-class medical devices and medical devices without Chinese instructions and labels
[Case Brief] In June 2022, the law enforcement officers of the Market Supervision and Administration Bureau of Gusu District, Suzhou City, Jiangsu Province inspected Suzhou Weishijian Medical Instruments and Equipment Import and Export Co., Ltd. based on the clues of the assisted investigation.
After investigation, the parties involved were suspected of operating unregistered imported medical devices such as intraocular lighting probes and phaco-wave cutting machines without Chinese instructions and labels. The value of the goods involved in the case was 20,988.73 yuan.
The party's operation of unregistered Class III medical devices and medical devices without Chinese instructions and labels violated the first and second paragraphs of Article 39 of the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739) Article 3 and Article 55.
In September 2022, the Gusu District Market Supervision and Administration Bureau of Suzhou City, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739), Article 88 Item 2, Article 81 Paragraph 1 Item 1 and " According to Article 13, Item 1 of Suzhou Municipal Market Supervision and Management Administrative Punishment Applicable Discretionary Regulations (Trial), it is decided to impose a lighter punishment on the party involved, confiscating illegal income, confiscating 104 unlicensed medical devices, and imposing a fine of 358,819.68 yuan. punishment.
[Typical significance] According to Article 55 of the "Regulations on the Supervision and Administration of Medical Devices" (Decree No. 739 of the State Council), medical device operators and users are not allowed to operate or use medical devices that have not been registered or filed in accordance with the law, have no qualification certificates, and expired, Failed and obsolete medical devices.
At present, the ophthalmic surgery technology is developing rapidly and the market competition is fierce. Some medical device business units have a weak sense of responsibility. Use of medical devices occurs.
The investigation and handling of this case has enabled medical device operators and users to understand the importance of legal operations, and has played a positive role in promoting the protection of consumer rights and the purification of the market environment.
7. The case of Guangzhou Henglan Biotechnology Co., Ltd. using banned cosmetic raw materials to produce cosmetics
[Introduction to the case] In March 2022, the Guangdong Provincial Drug Administration comprehensively analyzed and judged the clues of the case, and cooperated with the public security organs to conduct surprise inspections on Guangzhou Henglan Biotechnology Co., Ltd. and sampled some cosmetics.
After investigation, the company's Yingbeixuan baby skin cream and Yingkang prebiotic body lotion produced between November 2021 and March 2022 were found to contain clobetasol propionate and halobetasol, which are prohibited cosmetic ingredients. Propionate and cyproheptadine, the value of which is 212,667 yuan.
The Guangdong Provincial Drug Administration transferred the case to the public security organ in accordance with the law, and the public security organ has filed the case for investigation in accordance with the law.
At the same time, in view of the fact that the products involved in the case belong to children's cosmetics and the violations are serious, in October 2022, the Guangdong Provincial Drug Administration ordered the company's use of prohibited raw materials to produce cosmetics in accordance with Article 59, Section 3 of the "Regulations on the Supervision and Administration of Cosmetics". According to the provisions of this article, the administrative penalty of revoking its cosmetics production license, canceling its cosmetics product filing, refusing to handle its cosmetics filing and accepting its application for cosmetics administrative licensing within 10 years, the company's legal representative Wu Moumou, Mo Moumou, the person in charge of production, imposed an administrative penalty of banning him from engaging in cosmetics production and business activities for life.
[Typical Significance] The use of prohibited cosmetic raw materials to produce children's cosmetics or the illegal addition of substances that may endanger human health in children's cosmetics fall under the serious circumstances stipulated in Article 61 of the "Measures for the Supervision and Administration of Cosmetics Production and Operations". , should be severely punished according to law.
In this case, the drug supervision and management department took the initiative to dig deep into the clues of the source of the case, unblock the green channel for product inspection involved in the case, deepen the connection between the execution of the case, and cooperate with the public security organs to effectively crack down on illegal and criminal acts of illegal addition of children's cosmetics.
The drug supervision and management department imposed punishments such as revoking the cosmetics production license and canceling its product filings to the enterprises involved in the case in accordance with the law. The formation of a strong deterrent reflects the firm determination of the regulatory authorities to resolutely protect the safety of children's makeup.
8. "5.7" case of producing and selling counterfeit cosmetics in Yangzhou, Jiangsu
[Case Brief] On September 15, 2022, the People's Court of Guangling District, Yangzhou City, Jiangsu Province sentenced Zhang Moumou and other 8 criminals who produced and sold counterfeit cosmetics to fixed-term imprisonment ranging from three years to one year for crimes such as counterfeiting trademarks. and fined.
The discovery of this case stems from the illegal clues of the Yangzhou Inspection Branch of the Jiangsu Provincial Drug Administration in the monitoring of cosmetics safety risks.
After discovering the illegal clues of the above-mentioned counterfeit cosmetics, the Yangzhou Inspection Branch immediately set up a joint task force with the Food and Drug Environmental Investigation Detachment of the Yangzhou Municipal Public Security Bureau, insisted on tracing the source, followed the line, and finally destroyed 1 counterfeit cosmetics production den and 2 rubber hose suppliers. home, arrested Zhang Moumou and other suspects.
After investigation, since March 2020, Zhang Moumou and others purchased components such as pastes, imitation packaging materials, trademarks and anti-counterfeiting signs, processed and assembled them to produce counterfeit cosmetics, and sold them through the Internet.
[Typical Significance] In recent years, lawbreakers have targeted branded cosmetics for manufacturing and selling counterfeit products, seeking illegal benefits by relying on other people's high-quality brand effects.
In this case, the drug supervision and management department attaches great importance to the illegal clues discovered from the safety risk monitoring of cosmetics, and uses its professional and technical advantages to cooperate with the public security organs. The judiciary and obligee companies have worked together to wipe out the chain of counterfeit production and sales, effectively protect the safety of public makeup, maintain a fair competition market order, and create a good business environment.
9. "6.12" Case of Selling Counterfeit Cosmetics in Zhangzhou, Fujian
[Introduction to the case] In September 2021, the Zhangzhou Municipal Market Supervision and Administration Bureau of Fujian Province received a number of complaints and reports, reflecting that many Taobao stores with registered addresses in Zhao'an County, Zhangzhou City sold counterfeit brand cosmetics.
The Zhangzhou Municipal Market Supervision Administration immediately organized an investigation. After comprehensive research and judgment, the Zhaoan County Market Supervision Administration transferred the clues to the public security organs. At the same time, the market supervision and public security departments at the Zhangzhou City and county levels established a joint task force to jointly investigate the case.
In June 2022, the joint task force dispatched more than 100 law enforcement officers to Shenzhen in Guangdong, Dalian in Liaoning, Handan in Hebei, and Zhangzhou in Fujian to carry out network collection operations at the same time, destroying 6 counterfeit cosmetics dens in one fell swoop, and arresting 73 people involved in the case , seized a large number of counterfeit cosmetics.
Up to now, the People's Procuratorate of Zhao'an County has approved the arrest of the three main suspects in this case, transferred them for examination and prosecution, and released another 21 suspects on bail pending trial.
The case is under further investigation.
[Typical Significance] In recent years, as the crackdown on illegal and criminal cosmetics has been intensified, cosmetics counterfeiting dens have further shifted to remote areas such as rural areas and urban-rural junctions.
In this case, criminals formed a gang to commit crimes, scattered in remote areas such as Fujian and Guangdong, and divided work cases, and had a strong sense of anti-investigation. They opened multiple online stores on multiple e-commerce platforms, and produced and sold illegal cosmetics across provinces. .
The drug supervision and management department carefully investigated the illegal clues, did not let go of any clues, and cooperated closely with the public security organs to find out the context of the illegal activities in the whole case, and finally succeeded in destroying the black dens, maintaining the safety of public makeup.