Debund| Medical Health Law Information ( December 2022)

The legal team of Debund Medical Health Law has long been focusing on legal services in the medical and health field, and is well versed in the main business models of the medical and health industry and the internal operation processes of the enterprise, so that it can provide all-round legal services for medical enterprise customers.
2023-01-10 16:00:21

Introduction to the legal team of Debund Medical Health Law


The legal team of Debund Medical Health Law has long been focusing on legal services in the medical and health field, and is well versed in the main business models of the medical and health industry and the internal operation processes of the enterprise, so that it can provide all-round legal services for medical enterprise customers.


Our customers include large and famous pharmaceutical enterprises, as well as small and medium-sized enterprises and start-ups in the life sciences and medical and health fields. Our business scope covers the main fields of life science and medicine and health industry, especially in the fields of intellectual property protection, technology introduction, equity investment, mergers and acquisitions, project financing, compliance review, criminal civil intersection, dispute resolution, etc. We have rich practical experience, and can provide high-quality legal services for customer needs.


Contents of this issue: 


一、 Latest regulations

 

01. The State Drug Administration Department of comprehensive public consultation "Drug Network Sales Prohibition List (draft for comment)" comments

02. General Administration of Market Regulation on the public consultation "Special Medical Use Formula Labeling Guidelines (draft for comment)" comments

03. The State Bureau of Chinese Medicine issued the "Management of Chinese Medicine Statistics

04. State Administration of Pharmacy and Pharmaceutical Administration of the Department of comprehensive public consultation "Drug Listing Licensee to implement the main responsibility for drug quality supervision and management regulations (draft for comment)" comments

05. State Drug Administration Division on the supervision and management of drug network sales "to implement the work of the notice



二、 Latest case


01. Overpriced sales of carmustine injection, Zingya Pharmaceuticals is expected to be fined 27,721,300

02.Guizhou Province, 2022, the second batch of drug safety special rectification of typical cases

03.Hunan Province, Zhengqiao Chinese Medicine Beverage Co., Ltd. sales of substandard drugs case

04. Sichuan Rongkang Shi Sheng Pharmaceutical Co., Ltd. Xindu Branch production does not meet the mandatory standards, the technical requirements of registered products of medical devices case


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一、Latest Regulations

1. The State Drug Administration Comprehensive Department of public consultation "drug network sales ban list (draft for comment)" comments


Issuing authority : State Drug Administration comprehensive department

Issued on : November 2, 2022


        Recently, the State Drug Administration drafted the "Drug Network Sales Prohibition List (draft for comment)" (hereinafter referred to as "draft for comment"), is now open for comment, the feedback deadline of November 10.


        The "draft for comments" aims to further improve the drug network sales supervision policies, clarify the scope of drug network sales. The former refers to vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical chemicals, medical institution preparations, Chinese medicine formula granules. Other drugs banned from retail through the network contains injectables (except hypoglycemic drugs) and four other.


Source: State Drug Administration:(https://www.nmpa.gov.cn/ 


2. State Administration of Market Supervision on the public consultation "special medical use formula labeling guidelines (draft for comment)" comments


Issuing authority: State Administration of Market Supervision and Administration

Issuing date: November 7, 2022


        The State Administration of Market Supervision and Administration issued the "Special Medical Use Food Labeling Guidelines (Draft for Comments)" (hereinafter referred to as the "Draft for Comments"), is now open to the public for comments, feedback is due on November 25.


        The "draft" includes the basic requirements, the main content, the main display layout logo, other need to identify the content. Among them, "draft for comment" clear special medical food labeling should comply with the relevant laws, regulations, rules and national food safety standards, involving special medical food registration certificate content, should be consistent with the content of the registration certificate. Labels, instructions should be true and standardized, scientifically accurate, easy to understand, clear and legible, shall not contain false, exaggerated or absolute language. At the same time, reference to the "special medical use formula food labeling, instructions sample requirements (for trial implementation)", refining and improving the special medical food product names, product categories, ingredient lists and other 13 items. The technical guidelines for the registration of infant formula milk powder product labeling specifications (for trial implementation)," the content of some of the adjustments and additions.


        Compared to the previously released "special medical use formula labeling, instructions sample requirements (for trial implementation)," the "draft" more complete and detailed description of the special medical food packaging labeling requirements, although the "draft" does not have mandatory, but the actual operation of the enterprise has more guidance.


Source: State Administration of Market Supervision and Administration: (https://www.samr.gov.cn/)


3. The State Bureau of Traditional Chinese Medicine issued the "Management of Chinese Medicine Statistics‘’


Document number: State TCM regulation and finance [2022] No. 9

Issuing authority: State Administration of Traditional Chinese Medicine

Issuing date: November 4, 2022


        The State Administration of Traditional Chinese Medicine (SACM) issued the "Measures for the Management of Chinese Medicine Statistics (for Trial Implementation)" (hereinafter referred to as "Measures"), which shall be implemented from the date of issue.


        The Measures are divided into seven chapters: general provisions, institutions and personnel, statistical survey project management, statistical data management and statistical information services, statistical data security management, statistical supervision and rewards and punishments, and by-laws. The "approach" to clarify the classification of statistical survey projects, project establishment, system development, approval and filing, project organization and implementation, data quality control, etc.; standardized statistical data storage requirements, statistical information published, published information revision requirements, statistical information sharing, statistical analysis applications. The Measures point out that the competent departments of TCM and TCM statistical business support institutions at all levels should strictly implement the "Network Security Law", "Personal Information Protection Law", etc., implement the network security level protection system, implement the data classification and classification protection system, strengthen the security construction and operation and maintenance management of statistical business information systems and data, and implement key protection for critical information infrastructure and important data resources.


Source: State Administration of Traditional Chinese Medicine :(http://www.natcm.gov.cn)



4. The State Drug Administration (SDA) comprehensive department to publicly solicit comments on "the implementation of drug quality supervision and management of the main responsibility of drug licensees (draft for comment)


Issuing authority: State Drug Administration comprehensive department

Issued on: November 29, 2022


        State Drug Administration drafted the "Drug Listing Licensee to implement the main responsibility for the supervision and management of drug quality (draft for comment)" (hereinafter referred to as "draft for comment"), "the implementation of the main responsibility for the supervision and management of medical device quality and safety of enterprises (draft for comment)" and "the implementation of the main responsibility for the supervision and management of cosmetics quality and safety of enterprises (draft for comment)", now to the community for comment. Feedback are up to December 9.


        The "draft" requires that the holder shall establish and implement a drug traceability system, the construction of information technology traceability system, to the downstream drug business enterprises, drug use units to provide traceability information, timely and accurate records and save the entire process of drug production, circulation and other information to achieve traceability of drugs. Should establish and improve the drug recall system, found that the drug quality problems or other safety hazards, in accordance with the provisions of the recall, timely notification of the drug business enterprises, the use of units, while the investigation and evaluation report, recall plans and recall notices submitted to the provincial drug supervision and management departments for the record.


Source: State Drug Administration:(https://www.nmpa.gov.cn/)

   

5. State Drug Administration Comprehensive Department on the "supervision and management of drug network sales" to implement the work of the notice


Document number: Drug Administration comprehensive drug control letter [2022] No. 667

Issuing authority: State Drug Administration

Issuing date: November 30, 2022



        State Drug Administration issued a "notice on the supervision and management of drug network sales" to implement the "Notice" (hereinafter referred to as the "Notice"), "Drug Business Quality Management Standards Appendix 6: Drug Retail Distribution Quality Management", "Drug Network Sales Prohibition List (First Edition)", "on the standardization of drug network sales record and report on the work of the announcement" and other four documents.


        The Notice said, "Drug Network Sales Supervision and Administration" (the "Measures") shall come into force on December 1, 2022. Now from the practical awareness, do a good job "approach" publicity and training; accurate grasp of the focus, the "approach" to the implementation of the system; establish a sound mechanism, comprehensive supervision and management of drug network sales; strict investigation of illegal acts, to maintain the order of drug network sales and other four aspects of the arrangements. Among them, according to the "Notice", the use of electronic prescriptions to individuals selling prescription drugs, should sign an agreement with the medical institution or electronic prescription flow platform to ensure that the source of the prescription is authentic and reliable, the drug can be traced back to the consumer or patient.


        State Drug Administration stressed that drug regulatory departments at all levels should focus on the outstanding issues of drug network sales, adhere to both the symptoms and the root cause of the problem, heavy containment, strong pressure, long deterrent. For the third-party platform, to focus on the platform responsibility to perform, management of business practices and other aspects of illegal and illegal issues; for drug network sales enterprises, to focus on the sale of fake and substandard drugs, the state implementation of special management of drugs, over the scope, over the way to operate and other illegal and illegal issues. To find a number of, investigate and punish a number of, severely punish a number of exposure of a number of typical cases, forming a strong deterrent, and effectively maintain the order of drug network sales.


Source: State Drug Administration:(https://www.nmpa.gov.cn/)



二、 Latest Cases


1. Overpriced sales of carmustine injection, Zingya Pharmaceuticals is expected to be fined 27,721,300  


        (hereinafter referred to as "Jinyao Pharmaceutical") announced that its subsidiary Jinyao Pharmaceutical received a Notice of Administrative Penalty. The Tianjin Municipal Market Supervision and Administration Commission found that Jinyao Pharmaceutical abused its dominant position in the market of carmustine injection in China and sold carmustine injection at unfairly high prices. Jinyao Pharmaceuticals is proposed to be fined 27.72 million RMB.


        The State Drug Administration database shows that there are currently three domestic manufacturers of carmustine API, namely Jin Pharmaceutical, Hebei Metu Pharmaceutical Co. At present, only Jinyao Pharmaceutical and Hebei Meitu Pharmaceutical have the preparation approval for carmustine injection.


        According to public reports, Hebei Metu Pharmaceutical has suspended the production of carmustine injection, which means that only Jinyao Pharmaceutical is currently producing carmustine injection in China.


        According to the Tianjin Municipal Market Supervision and Administration Commission, Jinyao Pharmaceutical abused its dominant position in the Chinese market for carmustine injection by selling carmustine injection at unfairly high prices, in violation of Article 17(1)(a) of the pre-amendment Anti-Monopoly Law, which prohibits operators with a dominant market position from engaging in the following acts of abuse of dominant market position: (a) selling goods at unfairly high prices or at unfairly high prices. (1) selling goods at unfairly high prices or buying goods at unfairly low prices".


        According to Article 47 of the pre-amendment Anti-Monopoly Law, "An operator who abuses a dominant market position in violation of the provisions of this Law shall be ordered by the anti-monopoly enforcement agency to stop the illegal act, confiscate the illegal income, and impose a fine of not less than one percent of the previous year's sales." The Tianjin Municipal Market Supervision and Administration Commission intends to order Jinyao Pharmaceutical to stop the illegal acts and impose a fine of two percent of the 2019 annual sales, totaling 27,721,311.36 Yuan.


2. Guizhou Province in 2022, the second batch of drug safety special rectification of typical cases   


December 2, 2022 Guizhou Province Drug Administration announced the second batch of 2022 drug safety special rectification of typical cases.


(1) Guizhou Heng Sheng Pharmaceutical Co., Ltd. did not obtain a "drug business license" to operate traditional Chinese medicine Agaricus and traditional Chinese medicine tablets wine chasteberry, system He Shou Wu, wine Huang Jing case


        In March 2022, Guizhou Province Drug Administration to carry out law enforcement inspection found that Guizhou Jianrui An Pharmaceutical Co. Ltd. did not obtain a "drug business license" to operate the Chinese medicine Agaricus and Chinese herbal tablets wine chasteberry, system He Shou Wu, wine Huang Jing, the value of the drugs involved 537,400 yuan. The company violated the above violations of the "Drug Administration Law" Article 51, paragraph 1 of the provisions of October 2022, Guizhou Province Drug Administration in accordance with the "Drug Administration Law" Article 115 of the provisions, with reference to the "Guizhou Province Drug Supervision and Administration Administrative Punishment Discretionary Application Rules (for Trial Implementation)" Article 8, Article 9 of the provisions of the company made the order to close, a fine of 215,000 yuan The administrative penalty decision.



(2) Liupanshui Zhenrong Hospital Co., Ltd. from illegal channels to purchase drugs and cash transactions of Class II psychotropic substances case


        In December 2021, the Liupanshui Market Supervision Administration found, according to the notification of the public security department, that the doctor of Liupanshui Zhenrong Co., Ltd. did not check and obtain the qualification of the supplier, and purchased four kinds of drugs, such as diazepam injection and mifepristone, for hospital drug stock through WeChat from WeChat merchants who were not qualified to deal in drugs, and the illegal act of the company violated Article 55 of the Drug Administration Law, Article 30 of the Narcotic Drugs and Psychotropic Substances Regulations. In May 2022, Liupanshui Market Supervision Administration, in accordance with Article 129 of the Drug Administration Law and Article 8(5) of the Rules for the Use of Discretionary Power of Drug Administration and Supervision in Guizhou Province, imposed an administrative penalty of RMB 22,000 on the company.



(3) Qianxinan Qinglong Jikang Hospital use of substandard drugs case


        In July 2022, Qinglong County Market Supervision Administration carried out daily inspection found that Qinglong Jikang Hospital in its pharmacy qualified drug area stored more than the expiration date of 130 pieces of Feng Yuan brand contraction injection, the value of the drugs involved 572.26 yuan. The hospital's illegal behavior violated the provisions of Article 98, paragraph 1 of the Drug Administration Law. 2022 September, Qinglong County Market Supervision Administration in accordance with the provisions of Article 117, paragraph 1, Article 119 of the Drug Administration Law, ordered the parties concerned to correct the illegal behavior, and the parties concerned to confiscate the drugs involved, a fine of 100,100 yuan administrative penalty decision.



(4) Qiannan Luodian Min Kang Hospital use of medical devices without qualification documents, not registered according to law Olympus electronic gastroscope case


        In May 2022, Qiannan Market Supervision Administration, according to higher departments referred clues, and Guizhou Province Drug Administration to carry out joint law enforcement inspection found that June 1, 2021 to December 30, Luodian Min Kang Hospital to private borrowing without qualification documents, not legally registered medical devices Olympus electronic gastroscope to carry out treatment activities, the value of medical devices involved in 9,000 yuan. The hospital's illegal behavior violated the provisions of Article 55 of the Regulations for the Supervision and Administration of Medical Devices. 2022 October, Qiannan State Administration of Market Supervision in accordance with Article 28, paragraph 2, Article 32, paragraph 1 of the Administrative Punishment Law, Article 86, paragraph 3 of the Regulations for the Supervision and Administration of Medical Devices, with reference to the Guizhou Province Drug Supervision and Administration Administrative Punishment Discretionary Application Rules (for Trial Implementation) Article 10, paragraph 7 of the provisions of the hospital to confiscate the illegal income, fines totaling 36,600 yuan of administrative penalty decisions.



(5) Luodian dental Boshi dental clinic use of expired medical equipment case


        In May 2022, the Luodian County Market Supervision Administration carried out law enforcement inspections found that Luodian Dental Boshi Dental Clinic used expired dental occlusal paper and sterile surgical blades, purchased from unqualified enterprises without Chinese labels and could not provide supplier qualifications and bills for the products. The clinic's illegal behavior violated the "supervision and management of medical devices regulations" Article 55, Article 45, paragraph 1 and "medical device instructions and labeling regulations" Article 9, paragraph 1. 2022 August, Luodian County Market Supervision Administration in accordance with the "supervision and management of medical devices regulations" Article 86, paragraph 3, Article 88, paragraph 2, Article 89, paragraph 2, paragraph 3, the provisions of The clinic was warned, confiscated expired medical devices without Chinese labels and fined 25,000 yuan in administrative penalty decisions.



(6) Guiyang Sharma Pharmaceutical Co., Ltd. production does not meet the technical requirements of the products on record medical devices case


        In March 2022, Qingzhen Municipal Market Supervision Administration carried out daily inspections found that the products produced by Guiyang City Sharma Pharmaceutical Co. Ltd. produced products "Sharma Oil" (Gout 1), "Sharma Oil" (rheumatism), "Sharma Oil" (tinnitus special) and the record "medical device product technical requirements" information is inconsistent, the value of the medical devices involved 13.95 million yuan. In May 2022, Qingzhen Municipal Market Supervision Administration, in accordance with Article 86(1) of the Regulations on Supervision and Administration of Medical Devices and with reference to the Provisions on the Application of Discretionary Administrative Punishments in Guizhou Province, imposed a fine of RMB 71,000 on the company for confiscating the illegally manufactured medical devices. 71,000 yuan administrative penalty decision.



(7) Guiyang Yuecheng Hospital Co., Ltd. did not store medical devices in accordance with the labeling requirements case


        On April 20, 2022, Guiyang Guanshan Lake District Market Supervision Administration carried out supervision and inspection and found that Guiyang Yuecheng Hospital Co., Ltd. did not store sodium hyaluronate compound solution for injection in accordance with the labeling. It was found that the company purchased 5 batches of sodium hyaluronate compound solution for injection and sodium hyaluronate modified for injection from July 25, 2021 to April 14, 2022, which needed to be stored away from light and refrigerated, but the company actually stored them in a cooler after purchase. The company did not follow the labeling requirements for storage of medical devices in violation of the provisions of Article 47 of the Regulations for the Supervision and Administration of Medical Devices, involving a total value of 14.75 million yuan. June 2022 Guanshan Lake District Market Supervision Administration, in accordance with the provisions of Article 88, paragraph 3, of the Regulations for the Supervision and Administration of Medical Devices, the company was given a fine of 25,000 yuan administrative penalty decision.



(8) Guizhou Health Pharmaceutical Chain Co., Ltd. did not follow the provisions of the medical device network sales-related information to inform the drug supervision and management department case


        In April 2022, Changshun County Market Supervision Administration received a report from the public to carry out verification found that Guizhou Health Pharmaceutical Chain Co., Ltd. in the Meituan takeaway network platform exhibition and sale of self-adhesive soft poly-silicone dressings, Bark silicone ointment and other second-class medical devices need to operate for the record, but the company did not follow the provisions of the medical device network sales-related information to inform the drug supervision and management department. Changshun County Market Supervision Administration on April 19, 2022 the company issued a notice of correction, requiring it to correct the violation by May 4, but the company did not correct within the prescribed time limit. In June 2022, Changshun County Market Supervision Administration made an administrative penalty decision to fine the company 5,000 yuan in accordance with the provisions of Article 89, Paragraph 8 of the Regulations for the Supervision and Administration of Medical Devices.



(9) Qixingguan District Bee Encounter Department Store operating imported cosmetics without Chinese labels case


        In April 2022, the market supervision bureau of Qixingguan District, Bijie City, daily inspection found that the Qixingguan District Bee Encounter Department Store placed 13 kinds of cosmetics without Chinese labels on the outer packaging labeled "Snow Flower Show Sulwhasoo" and other words on the display shelves in the business premises for sale to the public, the value of the cosmetics involved in the case was 6,809 yuan. In April 2022, the Qixingguan District Market Supervision Administration, in accordance with the provisions of Article 61(1)(5) of the Cosmetics Supervision and Administration Regulations, confiscated all the cosmetics without Chinese labels, confiscated the illegal income and fined the department store 10,000 yuan. Administrative penalty decision.



(10) Dancai County, the color of the cosmetic store operating cosmetics did not establish and implement the purchase inspection record system case


        In July 2022, the Denzhai County Market Supervision Bureau to carry out daily inspections found that the Denzhai County Phylloxera cosmetics store sales of milk seaweed mask and plant Chinese medicine mask, can not provide supporting materials such as purchase documents, supplier qualifications, cosmetics registration or filing and product inspection reports, the value of the cosmetics involved in the case of 1,000 yuan, the party operating cosmetics did not establish and implement a system of inspection records of incoming goods In November 2022, Denzhai County Market Supervision Administration, in accordance with the provisions of Article 32, Paragraph 5 of the Administrative Penalty Law, Article 62, Paragraph 1, Item 2 of the Regulations on the Supervision and Administration of Cosmetics, with reference to the General Administration of Market Supervision on the Guidance on the Regulation of Market Supervision and Administration of Administrative Penalty Discretion, Article 14, Paragraph 2 and 3 of the Regulations, imposed a penalty on the person concerned. The second and third provisions of the administrative penalty decision on the person concerned a fine of 5,000 yuan.



3 .Hunan Zhengqiao Chinese Medicine Co., Ltd. sales of substandard drugs


        November 28, 2022 Hunan Provincial Drug Administration made Hunan Drug Administration drug penalty [2022] No. 38 administrative penalty decision, according to the Changsha City Food and Drug Inspection Institute test report 2, report number: YP2022W0083, YP2022W0085, labeled production unit: Hunan Province Zhengqiao Chinese Medicine Pieces Co. Ltd. and Changde Mingde Pharmaceutical Co., Ltd., variety: forsythia, lot number: 2203001, 2108001, unqualified items: [content determination]. According to the "Drug Administration Law of the People's Republic of China", Article 98, paragraph 3 (a) "the content of drug ingredients does not meet the national drug standards", the above-mentioned forsythia should be substandard drugs. Ltd. production and sales of the above two batches of Chinese herbal medicines Lianjia illegal income of 137,859.81 yuan, the value of 148,706.11 yuan.


        Therefore, Hunan Provincial Drug Administration in accordance with the "People's Republic of China Drug Administration Law" Article 117, paragraph 1 of the provisions of the Hunan Province Zhengqiao Chinese Medicine Co., Ltd. to give the following administrative penalties: 1. confiscate batch No. 2108001 forsythia 107kg; 2. confiscate the illegal income of 137859.81 yuan; 3. illegal production and sales of drugs 1.5 times the amount of the value of the fine, totaling 223059.17 yuan. The above-mentioned forfeitures totaled 360918.98 yuan.



4. Sichuan Rongkang Shi Sheng Pharmaceutical Co., Ltd. Xindu Branch production does not meet the mandatory standards, the technical requirements of registered products medical devices case


        Sichuan Rongkang Shi Sheng Pharmaceutical Co., Ltd. Xindu Branch on November 7, 2021 produced batch number 211104 of single-use medical masks 48,000, all sold out, the value of 8,640 yuan, the above products by the Sichuan Provincial Institute of Drug Testing (Sichuan Medical Device Testing Center) test, the results do not meet the technical requirements of registered products.


        Sichuan Provincial Drug Administration on November 22, 2022 made Sichuan Drug Administration penalty [2022] No. 1034 administrative penalties, according to the "supervision and management of medical devices regulations" Article 86, paragraph 1 of the provisions of the Sichuan Rongkang Shi Sheng Pharmaceutical Co.