Taiwan Strait Network reported on May 21 that according to Fuzhou News Network, on the 20th, the Fuzhou Municipal People's Government website released a notice from the Fuzhou Municipal Administration for Market Regulation on the issuance of the "Fuzhou Municipal Drug and Medical Device Business License Inspector Management Measures (Trial)".
The original text is as follows:
All county (city) and district market supervision bureaus, relevant departments and directly affiliated units of municipal bureaus:
"Fuzhou City Drug and Medical Device Business License Inspector Management Measures (Trial)" has been issued in April 2020 It was reviewed and approved at the bureau executive meeting on the 15th and is now issued to you. Please comply with it carefully.
Attachment: "List of Municipal Inspectors"
Fuzhou Municipal Administration for Market Regulation
May 14, 2020
Fuzhou Municipal Drug and Medical Device Business License Inspector Management Measures
(Trial)
Chapter 1 General Provisions
Article 1 is Implement the spirit of the "Implementation Opinions of the Fuzhou Municipal Administration for Market Regulation on the Implementation of the Opinions on the Division of Drug Supervision Powers in Fujian Province (Interim)", standardize drug and medical device licensing inspections, and strengthen the management of drug and medical device business license inspectors, To ensure the quality of on-site inspections of drugs and medical devices, in accordance with the " Drug Administration Law ", "Drug Administration Law Implementation Regulations", "Medical Device Supervision and Administration Regulations", "Medical Device Operation Supervision and Administration Measures", "Medical Device Operation Quality Management Standards" and "Fujian The Provincial Measures for the Management of Drug Inspectors, the "Fujian Provincial Measures for the Management of Medical Device Inspectors" and the Municipal Market Supervision and Administration Bureau (hereinafter referred to as the "Municipal Bureau") party style and integrity construction and other relevant regulations have been specially formulated based on the actual work of our city.
Article 2 The inspectors referred to in these Measures refer to those who comply with the provisions of Article 4 of these Measures, have obtained provincial and municipal inspector qualifications and are included in the municipal inspector database, and undertake various tasks organized by the city's market supervision and management department. Professional staff responsible for on-site inspection of pharmaceuticals and medical devices, including drug business license inspectors and medical device business license inspectors (hereinafter collectively referred to as "inspectors").
Article 3 The Municipal Bureau is responsible for the construction, planning and management of the city's inspector team, and authorizes the Fuzhou Industrial Product Production License Review Technology Center (Fuzhou Food and Drug Evaluation Center, hereinafter referred to as the "Municipal Review Center") to serve as municipal inspectors Recruitment work; the municipal inspector database is divided into a qualification database and an appointment database. The Municipal Examination Center is specifically responsible for the selection, use, training, assessment, and management of municipal inspectors. The county (city) district market supervision and administration bureau (hereinafter) (referred to as "county (city) district bureau") is responsible for the daily management of the selection, use, and assessment of municipal inspectors within its jurisdiction.
Chapter 2 Basic Conditions for Inspectors and Appointment
Article 4 Drug and medical device inspectors shall meet the following conditions respectively:
(1) Law-abiding, decent style, good moral character, integrity and impartiality;
(2) Familiarity with drugs Relevant laws, regulations, rules and normative documents, and be able to correctly understand relevant inspection provisions and accurately apply them to on-site inspection practices;
(3) Should have a university degree or above in pharmacy or related majors or more than 3 years of experience in the supervision of drugs or devices .
(4) Have a college degree or above in a medical device-related major or have more than 3 years of experience in drug or device supervision or more than 1 year of review work experience.
(5) Have strong communication, communication and teamwork skills;
(6) Be in good health and able to adapt to the requirements of inspection work, and are generally no more than 60 years old;
(7) Obey the assignment.
Article 5 The relevant business offices of the Municipal Bureau, the bureau-affiliated units (i.e., the Drug and Cosmetic Circulation Supervision Office, the Medical Device Supervision Office, the Municipal Monitoring Service Center, the Municipal Food and Drug Inspection Institute, and the Municipal Review Center), as well as county (city) district bureaus Persons who meet the requirements of Article 4 of these Measures and have not obtained the qualification of an inspector shall be recommended by their unit, fill out the "Inspector Application Form", submit to the Municipal Examination Center for review, conduct unified training, pass the examination, and obtain the qualification of an inspector after being confirmed by the Municipal Bureau , be included in the municipal inspector qualification database. After on-site internship for more than 2 times, and after soliciting the opinions of the relevant inspection team leader, you can be hired as a municipal inspector and be included in the appointment database; participate in drug and medical device licensing inspection work and study for one week The above (inclusive), after soliciting the opinions of the relevant inspection team leaders, passing the examination of the Municipal Examination Center and reporting to the Municipal Bureau for confirmation, they can also be directly included in the Municipal Inspector Recruitment Database.
Chapter 3 Inspector Responsibilities
Article 6 Inspector Responsibilities:
(1) Under the leadership of the inspection team leader, in accordance with the division of labor in the on-site inspection plan, record the inspection situation in detail and do a good job of evidence collection, and divide the labor Responsible for the content of the on-site inspection;
(2) Assist the inspection team leader to summarize the inspection situation and evaluate the situation of the inspected enterprise objectively and fairly;
(3) Consciously abide by the on-site inspection discipline;
(4) When the inspectors disagree on the inspection conclusion , members of the inspection team can reserve their own opinions and make explanations in their personal on-site inspection records, and the final conclusion is decided by the inspection team leader.
Article 7: On-site inspections implement the inspection team leader responsibility system. The team leader’s job responsibilities are:
(1) Responsible for organizing and coordinating on-site inspection work according to the on-site inspection plan;
(2) Presiding over on-site inspection related meetings to clarify on-site inspections Relevant requirements, namely inspection discipline, inspection scope, precautions, etc.;
(3) is responsible for the inspection team exchanging opinions with the inspected enterprise and listening to the statement and defense of the inspected enterprise;
(4) is responsible for summarizing the inspection situation and organizing the writing of on-site inspections. report, and is responsible for the final inspection conclusion;
(5) is responsible for supervising the implementation of on-site inspection disciplines by members of the inspection team during the inspection;
(6) is responsible for requesting instructions on major issues during the on-site inspection;
(7) submits for on-site inspection Reports and related information.
Chapter 4 Code of Conduct for Inspectors
Article 8 Code of Conduct for Inspectors:
(1) Strictly abide by the spirit of the eight central regulations, the "four most stringent" requirements and relevant regulations on political integrity, and are formulated in accordance with laws and regulations on drugs and medical devices
(2) Be loyal to one's duties, adhere to principles, seek truth from facts, and be objective and fair;
(3) Strictly implement on-site inspection evaluation standards, on-site inspection plans and inspection disciplines;
(4) Truthfully record on-site inspection situations, and be objective and fair Evaluate the situation of the inspected enterprise;
(5) The inspection results and related information shall not be disclosed before the inspection results of the inspected enterprise are announced;
(6) Except for requesting relevant evidence and materials from the inspected enterprise as required by the work, shall not Request other technical information; the information and materials provided by the inspected enterprise shall not be leaked or used for purposes other than inspection, and the business secrets of the inspected enterprise shall not be disclosed to the outside world;
(7) shall not make things difficult for the inspected enterprise, and shall not ask for or accept the enterprise's property. , shall not sell operating equipment to the enterprise or seek other illegitimate interests; shall not participate in any form of banquets, entertainment, tourism and other activities of the inspected enterprise; shall not reimburse the inspected enterprise for various expenses that should be borne by the inspector himself; during the inspection period, comply with regulations Standard food and accommodation;
(8) If there is a direct interest in the inspected enterprise, the inspector should take the initiative to declare and apply for recusal; the inspector, his/her affiliated unit, and the specific related person should not have any contract or part-time job with the inspected unit. interests in obtaining remuneration; the inspector and the specific related person have not provided on-site training or guidance activities to the inspected unit within one year before the on-site inspection;
(9) Inspectors shall not lower inspection standards due to internal and external pressure , change the inspection process and inspection conclusions.
Chapter 5 Selection of Inspectors
Article 9 When selecting inspectors to participate in on-site inspections of drugs and medical devices, the following principles should be followed:
(1) Inspectors selected by municipal and county bureaus should all have municipal-level inspector qualifications. The Municipal Examination Center selects inspectors from the municipal pool of appointed inspectors and can also select trainee inspectors from the municipal qualification pool. Provincial drug business licensing inspectors can participate in municipal drug licensing on-site inspections, and inspectors from the provincial and municipal drug business licensing inspector databases can participate in municipal medical device licensing on-site inspections.
(2) Cities and counties share responsibility and make overall arrangements. The Municipal Inspection Center determines the number and composition of the inspection team based on the size of the unit being inspected or the risk level of the product. Each group shall have no less than 2 inspectors (one of which shall be selected from the county (city) district bureau where the enterprise is registered). ;
(3) The Municipal Inspection Center selects inspectors based on the needs of inspection tasks and adopts a combination of random selection and communication and coordination on the basis of professional matching. The relevant business offices of the Municipal Bureau, the Municipal Monitoring Service Center, and the Municipal Food and Drug Inspection Institute It is jointly responsible for the licensing inspection work with the municipal inspection center and county (city) district bureaus;
(4) implements an avoidance system, and inspectors who have interests related to the inspected unit are not allowed to be selected to participate in the inspection.
Article 10 The unit where the inspector works shall actively support the construction of the inspector team and actively support the inspectors to participate in on-site inspections. They shall not refuse to dispatch without special reasons.
Article 11 The inspector himself shall obey the dispatch and use. For those who participate in municipal inspections every year and have rich inspection experience, the municipal review center will give priority to recommending them as provincial inspectors. After receiving the notice of on-site inspection of drugs and medical devices, inspectors should not refuse to participate without special reasons. If it is indeed impossible to participate, a written explanation should be given and the opinion should be signed by the leader of the unit where the unit is located, and the unit where the unit is located will assign other inspectors to participate.
Article 12 The Municipal Bureau’s Drug and Cosmetic Circulation Supervision Office, Medical Device Supervision Office, Municipal Monitoring Service Center, Municipal Food and Drug Inspection Institute, and county (city) district bureaus should encourage and support the personnel of their departments (units) to actively participate in inspectors Training and selection work.
Article 13 The support of each county (city) district bureau for the transfer of inspectors can be used as the municipal bureau’s quantitative standard for the annual assessment of each county (city) district bureau, reflected in the points of extra points, and will be statistically reported by the municipal review center City Bureau confirmed.
Article 14 The selection of inspectors for various types of supervision and inspections such as tracking, special projects, and flights shall be carried out in accordance with the "Notice of the State Administration on Further Improving Random Inspections on Food and Drug Safety and Strengthening During and Post Supervision". Specific measures may be formulated separately. .
Chapter 6 Supervision and Management of Inspectors
Article 15 The daily education, management and supervision of inspectors shall be the responsibility of their units; during the period when inspectors are transferred, the units responsible for their management shall be responsible for the management.
Article 16 The municipal inspector team shall implement a dynamic management mechanism of unit review, education and training, qualification examination, inspection and recruitment, and comprehensive evaluation.
Article 17 The Municipal Inspection Center shall formulate an annual plan for inspector training and organize and implement it according to the plan.
Article 18 The professional training of inspectors listed in the municipal inspector database shall be the unified responsibility of the municipal inspection center. Inspectors shall actively participate in various trainings organized by provincial and municipal bureaus.
Article 19 Before on-site inspection, all members of the inspection team shall submit an integrity commitment to the dispatched unit and provide truthful feedback on the implementation of on-site inspection disciplines.
Article 20 The Municipal Inspection Center is responsible for establishing municipal inspector management files, recording the inspector's attendance, reasons for being transferred and failing to participate in on-site inspections, and inspection report errors, as the basis for the inspector's renewal.
Article 21 When participating in on-site inspections of drugs and medical devices, inspectors shall consciously maintain the image of the market supervision system and shall not damage the legitimate rights and interests of the inspected enterprises.
Article 22 If anyone refuses to participate in on-site inspections three times within a year without justifiable reasons, the inspector's qualifications may be revoked and announced.
Article 23 Under any of the following circumstances, the inspector may apply to the Municipal Examination Center, and upon review by the Municipal Examination Center, submit to the Municipal Bureau for approval before terminating his or her qualification as an inspector:
(1) The physical condition is not suitable for inspection work;
(2) Job change and inability to perform duties.
Chapter 7 Accountability
Article 24 Market supervision and management departments at all levels shall supervise and manage the quality of on-site inspections organized by themselves. In case of any of the following circumstances, the inspectors will be held accountable in strict accordance with the relevant national, provincial and municipal documents and regulations, and will be given critical education, admonishment talks, revoked qualifications of the inspector and notified, and party and government disciplinary sanctions will be given depending on the severity of the case. If a crime is constituted, the case shall be transferred to the judicial authorities for handling:
(1) Violation of disciplines and integrity regulations for inspection of drugs and medical devices upon verification;
(2) During on-site inspection, violation of legal procedures and ultra vires to make requests unrelated to the inspection;
(3) Deliberately concealing serious problems existing in the production and operation process of drugs and medical devices during on-site inspections;
(4) Other violations of relevant inspection work disciplines of the State Administration, provincial bureaus, provincial centers, municipal bureaus, and municipal review centers and violation of the code of conduct for inspectors in Chapter 4 of these Measures.
Chapter 8 Supplementary Provisions
Article 25 Relevant technical experts may be invited to participate in on-site inspections to assist inspectors in conducting inspections. Technical experts provide guidance and advice on specific technical issues involved in inspections. The code of conduct for technical experts participating in on-site inspections shall refer to these Measures.
Article 26 The Municipal Examination Center is responsible for dynamically updating the inspector qualification database and appointment database.
Article 27 These Measures are interpreted by the Fuzhou Municipal Administration for Market Regulation, and are specifically undertaken by the Fuzhou Industrial Product Production License Review Technology Center (Fuzhou Food and Drug Evaluation Center).
Article 28 These Measures shall come into effect on the date of promulgation.
Taiwan Strait Network reported on May 21 that according to Fuzhou News Network, on the 20th, the Fuzhou Municipal People's Government website released a notice from the Fuzhou Municipal Administration for Market Regulation on the issuance of the "Fuzhou Municipal Drug and Medical Device Business License Inspector Management Measures (Trial)".
The original text is as follows:
All county (city) and district market supervision bureaus, relevant departments and directly affiliated units of municipal bureaus:
"Fuzhou City Drug and Medical Device Business License Inspector Management Measures (Trial)" has been issued in April 2020 It was reviewed and approved at the bureau executive meeting on the 15th and is now issued to you. Please comply with it carefully.
Attachment: "List of Municipal Inspectors"
Fuzhou Municipal Administration for Market Regulation
May 14, 2020
Fuzhou Municipal Drug and Medical Device Business License Inspector Management Measures
(Trial)
Chapter 1 General Provisions
Article 1 is Implement the spirit of the "Implementation Opinions of the Fuzhou Municipal Administration for Market Regulation on the Implementation of the Opinions on the Division of Drug Supervision Powers in Fujian Province (Interim)", standardize drug and medical device licensing inspections, and strengthen the management of drug and medical device business license inspectors, To ensure the quality of on-site inspections of drugs and medical devices, in accordance with the " Drug Administration Law ", "Drug Administration Law Implementation Regulations", "Medical Device Supervision and Administration Regulations", "Medical Device Operation Supervision and Administration Measures", "Medical Device Operation Quality Management Standards" and "Fujian The Provincial Measures for the Management of Drug Inspectors, the "Fujian Provincial Measures for the Management of Medical Device Inspectors" and the Municipal Market Supervision and Administration Bureau (hereinafter referred to as the "Municipal Bureau") party style and integrity construction and other relevant regulations have been specially formulated based on the actual work of our city.
Article 2 The inspectors referred to in these Measures refer to those who comply with the provisions of Article 4 of these Measures, have obtained provincial and municipal inspector qualifications and are included in the municipal inspector database, and undertake various tasks organized by the city's market supervision and management department. Professional staff responsible for on-site inspection of pharmaceuticals and medical devices, including drug business license inspectors and medical device business license inspectors (hereinafter collectively referred to as "inspectors").
Article 3 The Municipal Bureau is responsible for the construction, planning and management of the city's inspector team, and authorizes the Fuzhou Industrial Product Production License Review Technology Center (Fuzhou Food and Drug Evaluation Center, hereinafter referred to as the "Municipal Review Center") to serve as municipal inspectors Recruitment work; the municipal inspector database is divided into a qualification database and an appointment database. The Municipal Examination Center is specifically responsible for the selection, use, training, assessment, and management of municipal inspectors. The county (city) district market supervision and administration bureau (hereinafter) (referred to as "county (city) district bureau") is responsible for the daily management of the selection, use, and assessment of municipal inspectors within its jurisdiction.
Chapter 2 Basic Conditions for Inspectors and Appointment
Article 4 Drug and medical device inspectors shall meet the following conditions respectively:
(1) Law-abiding, decent style, good moral character, integrity and impartiality;
(2) Familiarity with drugs Relevant laws, regulations, rules and normative documents, and be able to correctly understand relevant inspection provisions and accurately apply them to on-site inspection practices;
(3) Should have a university degree or above in pharmacy or related majors or more than 3 years of experience in the supervision of drugs or devices .
(4) Have a college degree or above in a medical device-related major or have more than 3 years of experience in drug or device supervision or more than 1 year of review work experience.
(5) Have strong communication, communication and teamwork skills;
(6) Be in good health and able to adapt to the requirements of inspection work, and are generally no more than 60 years old;
(7) Obey the assignment.
Article 5 The relevant business offices of the Municipal Bureau, the bureau-affiliated units (i.e., the Drug and Cosmetic Circulation Supervision Office, the Medical Device Supervision Office, the Municipal Monitoring Service Center, the Municipal Food and Drug Inspection Institute, and the Municipal Review Center), as well as county (city) district bureaus Persons who meet the requirements of Article 4 of these Measures and have not obtained the qualification of an inspector shall be recommended by their unit, fill out the "Inspector Application Form", submit to the Municipal Examination Center for review, conduct unified training, pass the examination, and obtain the qualification of an inspector after being confirmed by the Municipal Bureau , be included in the municipal inspector qualification database. After on-site internship for more than 2 times, and after soliciting the opinions of the relevant inspection team leader, you can be hired as a municipal inspector and be included in the appointment database; participate in drug and medical device licensing inspection work and study for one week The above (inclusive), after soliciting the opinions of the relevant inspection team leaders, passing the examination of the Municipal Examination Center and reporting to the Municipal Bureau for confirmation, they can also be directly included in the Municipal Inspector Recruitment Database.
Chapter 3 Inspector Responsibilities
Article 6 Inspector Responsibilities:
(1) Under the leadership of the inspection team leader, in accordance with the division of labor in the on-site inspection plan, record the inspection situation in detail and do a good job of evidence collection, and divide the labor Responsible for the content of the on-site inspection;
(2) Assist the inspection team leader to summarize the inspection situation and evaluate the situation of the inspected enterprise objectively and fairly;
(3) Consciously abide by the on-site inspection discipline;
(4) When the inspectors disagree on the inspection conclusion , members of the inspection team can reserve their own opinions and make explanations in their personal on-site inspection records, and the final conclusion is decided by the inspection team leader.
Article 7: On-site inspections implement the inspection team leader responsibility system. The team leader’s job responsibilities are:
(1) Responsible for organizing and coordinating on-site inspection work according to the on-site inspection plan;
(2) Presiding over on-site inspection related meetings to clarify on-site inspections Relevant requirements, namely inspection discipline, inspection scope, precautions, etc.;
(3) is responsible for the inspection team exchanging opinions with the inspected enterprise and listening to the statement and defense of the inspected enterprise;
(4) is responsible for summarizing the inspection situation and organizing the writing of on-site inspections. report, and is responsible for the final inspection conclusion;
(5) is responsible for supervising the implementation of on-site inspection disciplines by members of the inspection team during the inspection;
(6) is responsible for requesting instructions on major issues during the on-site inspection;
(7) submits for on-site inspection Reports and related information.
Chapter 4 Code of Conduct for Inspectors
Article 8 Code of Conduct for Inspectors:
(1) Strictly abide by the spirit of the eight central regulations, the "four most stringent" requirements and relevant regulations on political integrity, and are formulated in accordance with laws and regulations on drugs and medical devices
(2) Be loyal to one's duties, adhere to principles, seek truth from facts, and be objective and fair;
(3) Strictly implement on-site inspection evaluation standards, on-site inspection plans and inspection disciplines;
(4) Truthfully record on-site inspection situations, and be objective and fair Evaluate the situation of the inspected enterprise;
(5) The inspection results and related information shall not be disclosed before the inspection results of the inspected enterprise are announced;
(6) Except for requesting relevant evidence and materials from the inspected enterprise as required by the work, shall not Request other technical information; the information and materials provided by the inspected enterprise shall not be leaked or used for purposes other than inspection, and the business secrets of the inspected enterprise shall not be disclosed to the outside world;
(7) shall not make things difficult for the inspected enterprise, and shall not ask for or accept the enterprise's property. , shall not sell operating equipment to the enterprise or seek other illegitimate interests; shall not participate in any form of banquets, entertainment, tourism and other activities of the inspected enterprise; shall not reimburse the inspected enterprise for various expenses that should be borne by the inspector himself; during the inspection period, comply with regulations Standard food and accommodation;
(8) If there is a direct interest in the inspected enterprise, the inspector should take the initiative to declare and apply for recusal; the inspector, his/her affiliated unit, and the specific related person should not have any contract or part-time job with the inspected unit. interests in obtaining remuneration; the inspector and the specific related person have not provided on-site training or guidance activities to the inspected unit within one year before the on-site inspection;
(9) Inspectors shall not lower inspection standards due to internal and external pressure , change the inspection process and inspection conclusions.
Chapter 5 Selection of Inspectors
Article 9 When selecting inspectors to participate in on-site inspections of drugs and medical devices, the following principles should be followed:
(1) Inspectors selected by municipal and county bureaus should all have municipal-level inspector qualifications. The Municipal Examination Center selects inspectors from the municipal pool of appointed inspectors and can also select trainee inspectors from the municipal qualification pool. Provincial drug business licensing inspectors can participate in municipal drug licensing on-site inspections, and inspectors from the provincial and municipal drug business licensing inspector databases can participate in municipal medical device licensing on-site inspections.
(2) Cities and counties share responsibility and make overall arrangements. The Municipal Inspection Center determines the number and composition of the inspection team based on the size of the unit being inspected or the risk level of the product. Each group shall have no less than 2 inspectors (one of which shall be selected from the county (city) district bureau where the enterprise is registered). ;
(3) The Municipal Inspection Center selects inspectors based on the needs of inspection tasks and adopts a combination of random selection and communication and coordination on the basis of professional matching. The relevant business offices of the Municipal Bureau, the Municipal Monitoring Service Center, and the Municipal Food and Drug Inspection Institute It is jointly responsible for the licensing inspection work with the municipal inspection center and county (city) district bureaus;
(4) implements an avoidance system, and inspectors who have interests related to the inspected unit are not allowed to be selected to participate in the inspection.
Article 10 The unit where the inspector works shall actively support the construction of the inspector team and actively support the inspectors to participate in on-site inspections. They shall not refuse to dispatch without special reasons.
Article 11 The inspector himself shall obey the dispatch and use. For those who participate in municipal inspections every year and have rich inspection experience, the municipal review center will give priority to recommending them as provincial inspectors. After receiving the notice of on-site inspection of drugs and medical devices, inspectors should not refuse to participate without special reasons. If it is indeed impossible to participate, a written explanation should be given and the opinion should be signed by the leader of the unit where the unit is located, and the unit where the unit is located will assign other inspectors to participate.
Article 12 The Municipal Bureau’s Drug and Cosmetic Circulation Supervision Office, Medical Device Supervision Office, Municipal Monitoring Service Center, Municipal Food and Drug Inspection Institute, and county (city) district bureaus should encourage and support the personnel of their departments (units) to actively participate in inspectors Training and selection work.
Article 13 The support of each county (city) district bureau for the transfer of inspectors can be used as the municipal bureau’s quantitative standard for the annual assessment of each county (city) district bureau, reflected in the points of extra points, and will be statistically reported by the municipal review center City Bureau confirmed.
Article 14 The selection of inspectors for various types of supervision and inspections such as tracking, special projects, and flights shall be carried out in accordance with the "Notice of the State Administration on Further Improving Random Inspections on Food and Drug Safety and Strengthening During and Post Supervision". Specific measures may be formulated separately. .
Chapter 6 Supervision and Management of Inspectors
Article 15 The daily education, management and supervision of inspectors shall be the responsibility of their units; during the period when inspectors are transferred, the units responsible for their management shall be responsible for the management.
Article 16 The municipal inspector team shall implement a dynamic management mechanism of unit review, education and training, qualification examination, inspection and recruitment, and comprehensive evaluation.
Article 17 The Municipal Inspection Center shall formulate an annual plan for inspector training and organize and implement it according to the plan.
Article 18 The professional training of inspectors listed in the municipal inspector database shall be the unified responsibility of the municipal inspection center. Inspectors shall actively participate in various trainings organized by provincial and municipal bureaus.
Article 19 Before on-site inspection, all members of the inspection team shall submit an integrity commitment to the dispatched unit and provide truthful feedback on the implementation of on-site inspection disciplines.
Article 20 The Municipal Inspection Center is responsible for establishing municipal inspector management files, recording the inspector's attendance, reasons for being transferred and failing to participate in on-site inspections, and inspection report errors, as the basis for the inspector's renewal.
Article 21 When participating in on-site inspections of drugs and medical devices, inspectors shall consciously maintain the image of the market supervision system and shall not damage the legitimate rights and interests of the inspected enterprises.
Article 22 If anyone refuses to participate in on-site inspections three times within a year without justifiable reasons, the inspector's qualifications may be revoked and announced.
Article 23 Under any of the following circumstances, the inspector may apply to the Municipal Examination Center, and upon review by the Municipal Examination Center, submit to the Municipal Bureau for approval before terminating his or her qualification as an inspector:
(1) The physical condition is not suitable for inspection work;
(2) Job change and inability to perform duties.
Chapter 7 Accountability
Article 24 Market supervision and management departments at all levels shall supervise and manage the quality of on-site inspections organized by themselves. In case of any of the following circumstances, the inspectors will be held accountable in strict accordance with the relevant national, provincial and municipal documents and regulations, and will be given critical education, admonishment talks, revoked qualifications of the inspector and notified, and party and government disciplinary sanctions will be given depending on the severity of the case. If a crime is constituted, the case shall be transferred to the judicial authorities for handling:
(1) Violation of disciplines and integrity regulations for inspection of drugs and medical devices upon verification;
(2) During on-site inspection, violation of legal procedures and ultra vires to make requests unrelated to the inspection;
(3) Deliberately concealing serious problems existing in the production and operation process of drugs and medical devices during on-site inspections;
(4) Other violations of relevant inspection work disciplines of the State Administration, provincial bureaus, provincial centers, municipal bureaus, and municipal review centers and violation of the code of conduct for inspectors in Chapter 4 of these Measures.
Chapter 8 Supplementary Provisions
Article 25 Relevant technical experts may be invited to participate in on-site inspections to assist inspectors in conducting inspections. Technical experts provide guidance and advice on specific technical issues involved in inspections. The code of conduct for technical experts participating in on-site inspections shall refer to these Measures.
Article 26 The Municipal Examination Center is responsible for dynamically updating the inspector qualification database and appointment database.
Article 27 These Measures are interpreted by the Fuzhou Municipal Administration for Market Regulation, and are specifically undertaken by the Fuzhou Industrial Product Production License Review Technology Center (Fuzhou Food and Drug Evaluation Center).
Article 28 These Measures shall come into effect on the date of promulgation.
List of municipal inspectors
1. List of qualified personnel for municipal drug inspectors
A total of 328 people, the list is as follows:
Municipal Market Supervision Bureau and units directly under the municipal bureau (including Municipal Food and Drug Inspection Institute, Municipal Monitoring Service Center, Municipal Food Center for Drug Evaluation, 16 people): He Zhen, Li Xin, Shi Longxi, Huang Feiyan, Chen Qingwei, Zhou Jin, Chen Min, Zhuang Huiqing, He Mingxiang, Chen Jing, You Xubiao, Wu Yujing, Lin Yiqing, Ye Jing, Wu Guichuan, Shen Juelin
Gulou District (15 people): Chen Zheng, Chen Yao, Chen Shanshan, Li Jie, Wu Luoxiang, Wang Chuanzhi, Lin Xinxin, Chen Hao, Lin Jinjun, Lin Deyue, Qian Shuxian, Zhang Jialin, Ke Simin, Wang Baozhen, Lu Dongjing
Taijiang District (8 people): Zhao Feng, Luo Zhuyun, Shi Lei, Liu Yan, Lin Hua, Fan David, Yuan Aiying, Chen Yuqing
Cangshan District (21 people): Cheng Jing, Wang Jingtao, Chen Bin, Wang Jingquan, Jiang Jianhua, Xiu Xiaojun, Dong Zhenxin, Huang Guolin, You Xiaoming, Mao Likan, Zhang Qing, Lin Peng, Luo Xueyan, Zhang Ling, Yu Ming, Ye Minggan, Li Renjun, Xie Huafeng, Li Biao, Wu Gaowu, Guo Shuhuan
Jin'an District (15 people) : Liu Zhiyong, Lin Hua, Lin Feng, Xiong Wu, Cui Qiang, Zheng Shujun, Hu Jianfeng, Gao Qi, Li Ying, Zheng Baoming, Wang Yuan, Chen Weimin, Shi Aiqing, Liao Huiling, Xu Zhongyuan
Mawei District (25 people): Zhang Shiyong, Liu Benwu, Ye Libin , Zhang Feng, Deng Qi, Zou Ying, Jiang Xiaofeng, Wang Guanglong, Yang Feng, Weng Lihua, Liao Yinghui, Lin Yuqing, Wan Xiongmao, Chen Chao, Wu Jianping, Li Guanyi, Wang Long, Feng Jianran, Zheng Xiaoxiang, Wu Yongbo, Chen Weizhong, Lin Siwen, Lin Shengzhi, Chen Hong, Ye Shihong
Changle District (80 people): Liu Xinmin, Lin Pinhua, Lin Huayu, Jiang Xuchun, Chen Benjin, Zheng Pingguan, Liu Xiaobin, Li Shuzhou, Chen Xueqing, Lin Xing, Lin Jin, Huang Muqi, Li Jianqun, Zheng Siyuan, Li Xuezhen, Lin Min, Lin Juan, Pan Xinglong, Gao Guohui, Zhuo Wen, Wang Libing, Zhou Kongli, Chen Hui, Zheng Tianqiu, Zheng Sheng, Hou Gengzhao, Yang Binqiong, Lin Fang, Feng Qian, Lin Qian, Zheng Xijian, Zheng Yusong, Qiang Yelai, Lin Mingxiu, Chen Xiangbin , Chen Weizhen, Chen Xinqin, Wang Chunyan, Shi Chunlin, Zhang Xia, Su Sunda, Lin Mizhen, Fang Hua, Chen Xiaoyan, Lin Qi, Xie Xiuqin, Chen Yanping, Zheng Meiguang, Yan Baozeng, Chen Xi, Liu Xugeng, Xu Wenchao, Chen Ziyun, Wang Xinle, Wu Mengjie, Yao Limei, Xie Yuanlong, Zhuo Wenjie, Huang Deshui, Chen Hui, Zhang Yiming, Chen Zewei, Zhang Shengxiang, Lin Feng, Chen Weiyi, Lin Qi, Zheng Weiqiang, Chen Zengyi, Wu Xincan, Wang Li, Huang Qiubin, Lin Simin, Yu Shangda, Lin Jin, Gao Xuemei, Lin Xiaoling, Jin Wenwen, Jiang Rui, Zheng Yining, Wei Yonghang
Fuqing City (28 people): Wang Zuzhen, Zhang Daiping, Yu Ying, Zhang Fen, Chen Xingqiang, Yan Jianwen, Lin Ruiyun, Chen Yun, Cao Zhiqing, Wei Yunyan, Shi Xiaocui, Zheng Feng, Ye Lin, Chen Shuang, Weng Yunren, Chen Wei, Zheng Qingling, Fu Dapeng, Chen Bo, Wang Tao, Yan Song, Lin Xiaoyi, Guo Zhi, Ye Peng, Lin Meijuan, Cai Shantong, Chen Qiaoxin, He Daowang
Minhou County (39 people): Zhang Mingyin, Huang Huajin, Cai Chunmei, Ye Jiawei, Huang Xiaoying, Yang Xiu, Jiang Renfeng, Pan Shaolian, Cheng Jian, Su Shiyuan, Chen Xinzhao, Liao Weizhi, Zhang Liang, Lin Qixin, Lin Beihui, Tang Xiucheng, Lin Guoxing, Huang Hengwei, Lin Xuemin, Zhang Shuren, Chen Shen, Huang Saiqin, Chen Xi, Li Xia, Huang Wenbin, Cai Liying, Zhou Yanfang, Peng Li, Wu Jian, Xiao Xinmin, Lai Jianfeng, Fan Xingjian, Lu Weifeng, Li Xia, Huang Wenbin, Wu Yulian, Lin Xin, Lin Xiao, Xu Qiang
Lian Jiang County (25 people): Chen Yan, Hu Yanqin, Wang Weifeng, Zhang Jianwen, Wu Zhengyu, Chen Shouzhong, Wu Xiuqin, Chen Feng, Zheng Ru, Teng Minjun, Lin Shen, Chen Qi, Yang Pingping, Ye Jianping, Zhu Min, Wu Liling, Du Min, Zhang Weijie, Li Shaoqin, Lin Rongxing, Lin Daxin, Shen Meili, Sun Jingguang, Qiu Hongqiang, Cai Zubiao
Minqing County (23 people): Lin Guohui, Li Peng, Wang Haojian, Lin Hong, Yu Xiaoping, Zheng Yunqian, Liu Bizeng, Lin Xiaonu, Lu Xianfeng, Huang Bin, Wang Caihong, Wang Jian, Huang Jingsen, Ruan Guoqian, Zheng Xibiao, Su Chengya, Gao Xuan, Chi Ting, Zheng Zuzhou, Shi Shujia, Chen Xiaona, Lin Ninghai, Zhu Zilong
Luoyuan County (13 people): Fang Lifeng, Lin Manjun, Wu Chuanxing, Shen Jiajing , Chen Chen, Li Han, Xie Zaiyong, Lin Cheng, Xue Yuan, Ye Rundong, Chen Wujian, Lai Xiaorong, Jiang Yuhan
Yongtai County (14 people): Ye Bei, Zhang Zhifeng, Ruan Xiao, Zhou Guanghua, Chen Jiaqiang, Liu Zhengkun, Ke Tingyun, Liu Runci, Ye Su, Xu Dongming, Lin Sen, Zhou Xin, Yan Yazhen, Hou Mengli
High-tech Zone (6 people): Zhu Guohua, Li Ruiqing, Weng Qicheng, Song Hui, Lin Yan, Chen Wentao
2. Municipal medical equipment The list of qualified inspectors
has a total of 334 people. The list is as follows:
Jin'an District (15 people): Liu Zhiyong, Lin Hua, Lin Feng, Xiong Wu, Cui Qiang, Zheng Shujun, Hu Jianfeng, Gao Qi, Li Ying, Zheng Baoming, Wang Yuan, Chen Weimin, Shi Aiqing, Liao Huiling, Xu Zhongyuan
Mawei District (30 people): Zhang Shiyong, Liu Benwu, Ye Libin, Zhang Feng, Deng Qi, Zou Ying, Jiang Xiaofeng, Wang Guanglong, Yang Feng, Weng Lihua, Liao Yinghui, Lin Yuqing, Wan Xiongmao, Chen Chao, Wu Jianping, Li Guanyi, Wang Long, Feng Jianran, Zheng Xiaoxiang, Wu Yongbo, Chen Weizhong, Lin Siwen, Lin Shengzhi, Chen Hong, Ye Shihong, Yu Jianli, Wang Chuanhua, Liang Ying, Liu Xiangdong, Cai Hong
Fuqing City (29 people): Wang Zuzhen, Zhang Daiping, Yu Ying, Zhang Fen, Chen Xingqiang, Yan Jianwen, Lin Ruiyun, Chen Yun, Cao Zhiqing, Wei Yunyan, Shi Xiaocui, Zheng Feng, Ye Lin, Chen Shuang, Weng Yunren, Chen Wei, Zheng Qingling, Fu Dapeng, Chen Bo, Wang Tao, Yan Song, Lin Xiaoyi, Guo Zhi, Ye Peng, Lin Meijuan, Cai Shantong, Chen Qiaoxin, He Daowang, Guo Ruhua
