"Administrative Measures for Inspectors of Shanxi Provincial Drug Administration"

Shanxi Provincial Drug Administration Office

March 14, 2022

Chapter 1 General Rules

Article 1 In order to standardize the on-site inspection of drugs (including vaccines, the same below), medical devices and cosmetics in Shanxi Provincial Drug Administration (hereinafter referred to as the Provincial Drug Administration), and strengthen the management of inspectors, in accordance with the "General Office of the State Council on the establishment of professional Opinions of the Team of Professional Drug Inspectors, "Administrative Measures for the Classification and Classification of Professional and Professional Drug Inspectors", "Administrative Measures for the Education and Training of Professional and Professional Drug Inspectors", "General Office of the Shanxi Provincial Government on Comprehensively Strengthening the Drug Supervision Capability" These Measures are formulated in light of the actual conditions of our province in accordance with relevant regulations such as the Notice of Construction.
Article 2 The term “inspector” as mentioned in these Measures refers to the inspector who is uniformly appointed by the Provincial Food and Drug Administration, and who, according to the law, conducts compliance confirmation and risks for the places and activities of the administrative counterpart engaged in the development, production, operation and use of drugs, medical devices, and cosmetics. Judges.
Article 3 The provincial bureau is responsible for the overall planning of the construction of the inspector team, and establishes a leading group for the appointment of inspectors to be responsible for the organization, leadership, supervision and guidance of the appointment of inspectors and the appointment of inspectors. The Shanxi Provincial Drug Inspection Center (Shanxi Provincial Vaccine Inspection Center, hereinafter referred to as the Inspection Center) is responsible for formulating and improving inspection working mechanisms, procedures and systems, and is responsible for the establishment of inspector pools, inspector training, assessment and other daily management work.
 
Chapter II Basic Conditions of Inspectors

Article 4 Inspectors shall meet the following basic conditions:
(1) Loyal to the Party and the people, loyal to the law, and love the cause of drug supervision;
(2) Possess good political morality, social morality and professional ethics;
(3) Have a sense of integrity and self-discipline, and strictly abide by disciplinary rules;
(4) Have a strong sense of professionalism, mission and responsibility, and have good teamwork and pioneering and innovative spirit;
(5) Possess the professional knowledge, educational qualifications, business ability and practical experience suitable for the inspection position;
(6) Possess the physical conditions to perform inspection duties.
 
Chapter III Duties and Rights of Inspectors

Article 5 Inspectors shall undertake the following duties:
(1) According to the work arrangement and dispatch, complete the inspection tasks arranged by the provincial bureau or inspection center, and part-time inspectors shall complete at least two inspection tasks dispatched by the provincial bureau or inspection center every year;
(2) Strictly implement the on-site inspection procedures, inspection plans and inspection standards, truthfully record the on-site inspection situation, make an objective and fair comprehensive evaluation, and submit the on-site inspection report and relevant materials on time;
(3) According to the needs of inspection work, actively participate in inspection laws and regulations, the formulation and revision of relevant professional technical documents, subject research, etc.;
(4) Actively update knowledge, participate in continuing education and training on time, and strive to improve inspection work ability;
(5) Timely and proactively update personal information and truthfully report inspection work;
(6) Strictly implement the work requirements for preventing conflicts of interest and abide by relevant confidentiality regulations.
Article 6 Inspectors have the following rights:
(1) independently and fully express opinions and make judgments in accordance with the law;
(2) When performing tasks, they can enter relevant areas, consult and retrieve documents and records, access information systems, and inquire about relevant personnel;
(3) Enjoy personal accident insurance, regular physical examination, vaccination and occupational safety protection rights in specific inspection areas;
The personal accident insurance for full-time and part-time inspectors shall be handled by the inspection center in accordance with the one-time work-related death compensation standard of work-related injury insurance; the regular physical examination of part-time inspectors shall be the responsibility of their employers; the safety protection equipment shall be provided by the inspection center according to actual needs.
 
Chapter 4 Sequences and Types

Article 7 According to product categories, provincial inspectors are divided into 3 inspection sequences for drugs, medical devices, and cosmetics. Under each sequence, they are subdivided into the following types according to the supervision requirements of the whole product chain, whole cycle and whole process.
Drug sequence: drug non-clinical inspector, drug clinical inspector, drug production inspector, drug circulation inspector;
Medical device sequence: medical device clinical inspector, medical device production inspector, medical device circulation inspector;
Cosmetics Sequence: Cosmetics R&D Inspector, Cosmetic Production Inspector, Cosmetic Circulation Inspector.
Article 8 Inspectors can obtain multiple types of qualifications, and different types of inspectors shall have corresponding educational levels and professional backgrounds.
Non-clinical drug inspectors, clinical drug inspectors, and drug production inspectors must have a full-time undergraduate degree or above.
Medical device clinical inspectors, cosmetic research and development inspectors, medical device production inspectors, and cosmetic production inspectors must have a bachelor's degree or above.
Drug distribution inspectors, medical device distribution inspectors, and cosmetic distribution inspectors must have a college degree or above.
According to the needs of the inspection work, inspectors with more than 5 years of work experience in drug inspection and rich work experience may appropriately relax the conditions and be hired as provincial inspectors after collective discussion and approval by the inspector appointment work leading group.
 
Chapter 5   Hierarchies and Levels

Article 9 Inspectors are divided into four levels under each inspection type: primary, intermediate, advanced and expert. Among them, the posts of senior inspectors and above are generally not less than 35%, the posts of intermediate inspectors are not less than 30%, and the posts of junior inspectors are not less than 30%. Inspector positions are not more than 35%.
Article 10 Inspectors at all levels shall have the following basic qualifications:
(1) Junior Inspector: familiar with the laws and regulations, technical specifications and related regulations on the supervision of drugs, medical devices and cosmetics; have strong observation and analysis, communication and writing skills; have corresponding on-site inspection skills. Should have more than 1 year of relevant professional work experience (including but not limited to: supervision, inspection, review and approval, inspection and testing, clinical research, standard research, production and operation quality management, inspection and case handling, post-marketing monitoring and evaluation, etc., the same below) .
(2) Intermediate inspectors: have strong ability to find, analyze and solve problems; have strong organizational management ability. Should have more than 5 years of relevant professional work experience or more than 3 years of work experience as a junior inspector, and the annual assessment results of the past 3 years are all qualified or above.
(3) Senior inspector: have strong organizational leadership ability; have expertise in the corresponding field, be good at summarizing inspection rules; have strong academic research ability, and be able to solve major technical problems related to this field. Should have more than 10 years of relevant professional work experience or more than 5 years of intermediate inspector work experience, and the annual assessment results in the past 5 years are all qualified or above.
(4) Expert-level inspectors: have strong organizational leadership ability, are good at discovering and cultivating talents; have high academic status and influence in the corresponding field; have strong strategic thinking, academic research ability, and innovation ability. They should have more than 15 years of relevant professional work experience or more than 5 years of work experience as a senior inspector, and the annual assessment results of the past 5 years are all qualified or above.
Article 11 Inspectors at all levels shall perform the following duties:
(1) Junior Inspector: Participate in the formulation of inspection plans, undertake on-site inspection tasks commensurate with capabilities, participate in the writing of inspection reports; participate in the preparation of technical documents; participate in the research on inspection-related topics, etc.
(2) Intermediate inspectors: organize the formulation of inspection plans and write inspection reports; undertake on-site inspection tasks commensurate with their abilities, and participate in major and complex inspection tasks; participate in the technical inspection of inspection work, and participate in the study of major complex and difficult issues; participate in scientific research in the field Inspection system and theory building work.
(3) Senior inspector: organize and carry out the inspection tasks of major, complex and high-risk varieties; participate in the establishment or improvement of the drug inspection work system in the professional field, participate in the drafting of relevant technical standards and guiding principles in the professional field; be responsible for the inspection of the professional field Provide advice on handling difficult problems in the work; guide and train intermediate and junior inspectors to carry out their work.
(4) Expert-level inspectors: Participate in the decision-making of major reforms and development in the field of drug inspection; be responsible for the technical control of inspection work in the corresponding jurisdiction and in the corresponding field, and participate in the study of major complex and difficult problems encountered in on-site inspections. Provide decision-making suggestions for emergency investigation plans and conclusions of incidents; participate in research work such as drug inspection development planning; undertake the preparation of documents such as drug inspection quality management standards, relevant technical standards and guidelines in this field; guide and train other inspectors to carry out their work.

Chapter VI   Appointment and Level Evaluation

Article 12   Inspector appointment work leading group, according to the work needs, carry out the selection and appointment of inspectors in a timely manner.
Article 13 The first appointment of an inspector shall be carried out in accordance with the following procedures:
(1) Individual application
Persons who have the basic qualifications for inspectors can apply based on their professional background, work experience, etc., against the selection notice, and sign a statement on the prevention of conflict of interest. The content of the application shall include the inspection sequence, type and level. The unit and department to which the individual belongs will review the application, issue a recommendation, and make a commitment to cooperate and dispatch.
(2) Selection by merit
Entrusted by the provincial bureau, the inspection center selects the best inspectors according to the qualifications.
(3) Pre-job training
Those who pass the selection should participate in pre-job training and pass the assessment. Pre-job training includes theoretical training and practical training. Theoretical training includes courses in political theory, ethics, cultural knowledge, clean government discipline, laws and regulations, professional skills, and comprehensive management subjects. Practical training includes inspection training, simulated inspection, etc.
(4) Probationary inspection
The inspection center shall arrange for the applicant to participate in 2 probationary inspections according to the inspection type, and the inspection team leader shall give evaluation opinions on their performance; new inspectors with more than 3 years of work experience in the corresponding categories of supervision, review, inspection, monitoring and evaluation, etc. , the probationary inspection requirement can be waived. The probationary period generally does not exceed 1 year.
(5) Appointment
After the probationary inspection, the inspection center will make a comprehensive evaluation of the applicant based on the training assessment and probationary inspection, and then put forward employment recommendations. The provincial bureau determines the list of candidates to be hired based on the appointment proposal and the basic situation of the applicants, and publishes it on the provincial bureau website for a period of not less than 5 working days. After there is no objection in the announcement, the applicant will be appointed as an inspector and a "Drug Inspector's Certificate" will be issued.
Article 14 The term of employment of an inspector shall not exceed 5 years, and an assessment of the term of employment shall be conducted before the expiration date.
Article 15 When an inspector applies for an additional inspection type or is transferred to another inspection type, the procedure for initial appointment shall be followed. When a new type of pre-job training is carried out, the general knowledge and inspection business knowledge that have been trained can no longer be repeated.
Article 16   Inspectors who have obtained the qualifications of national inspectors of the corresponding category can be directly hired as provincial inspectors of the corresponding category. Inspectors who have obtained the qualification of inspectors of the corresponding category of the provincial bureau and meet the provisions of Article 11 of these Rules can be directly hired as inspectors of the corresponding category at the provincial level after re-assessment and evaluation.
According to the needs of drug inspection work, a small number of high-level talents or personnel with rich work experience in blood products, biological products (vaccines) and other high-risk drug inspections, outstanding professional ability, and high comprehensive quality are reviewed by the provincial bureau inspector appointment work leading group After passing, they can be directly hired as senior inspector or expert inspector.
Article 17 According to the qualifications of the inspectors at all levels, combined with the inspection work experience and the performance of inspection duties, the inspectors shall be evaluated at different levels.
The inspector-level assessment adheres to the principles of having both ability and political integrity, focusing on actual performance, scientific evaluation, and openness and transparency, including procedures such as individual application or expert recommendation, qualification review, and evaluation and assessment. The specific methods for level assessment will be formulated separately.
 
Chapter 7 Training

Article 18 The inspector training work adheres to the principles of service supervision, teaching on demand, connecting with reality, and advancing with the times, and comprehensively improves the quality and effectiveness of training in combination with the job responsibilities of inspectors and the needs of inspection work.
Article 19 The provincial bureau is responsible for the macro guidance, supervision and inspection of the education and training of provincial inspectors. The inspection center formulates an annual training plan for inspectors according to the actual work, and conducts training through self-organization or entrusting education and training institutions.
Article 20 Inspectors should actively participate in various forms of training to continuously improve on-site inspection capabilities and inspection levels. The inspection center needs to establish a unified professional and systematic training model based on the types of inspectors and the characteristics of their positions, and build an integrated training mechanism for inspectors to teach, learn, practice, and inspect.
Article 21 Inspector training is divided into pre-job training and continuing education training.
Pre-job training includes theoretical study and practical training, and the duration is not less than 40 hours. Theoretical training includes general knowledge training and professional knowledge training. General knowledge training includes basic party theory and party spirit education, official document writing skills, clean government discipline, confidentiality regulations, behavior etiquette, communication skills, finance, computer knowledge, etc. Professional knowledge training should be based on the type of inspectors, and the relevant professional knowledge required to perform job duties should be trained in a targeted manner, including laws and regulations related to administrative law enforcement, new knowledge, new technologies, inspection workflow and skills, and basic theoretical knowledge of various inspections, etc. . Practical training should use the equipment and teaching resources of the training base to carry out on-site teaching on all aspects of the drug inspection work through the combination of on-site teaching and simulated inspection, so as to promote the inspectors to fully understand the laws and regulations of drug supervision and inspection, and improve the inspection quality and inspection. ability.
Continuing education and training is based on the principle of "what is missing and what to make up for", and a training outline is formulated at different levels and types to meet the training requirements of inspectors at different levels.
The primary inspectors aim to improve their ability to find problems, write and communicate, and focus on training drug regulatory laws and regulations and the theoretical knowledge of basic inspections.
The intermediate inspector aims to improve the ability to find problems, organize and coordinate, and focus on the pertinence and effectiveness of inspections, focusing on training inspection skills, inspection case analysis, and new processes and technologies in the field of expertise.
The senior inspectors aim to improve their research and analysis ability, problem-solving ability, communication and coordination ability, and improve the quality of inspection work, and focus on training inspection work skills, international drug regulatory laws and regulations, international inspection technical standards and guiding principles.
The expert-level inspectors aim to improve the ability of risk research and judgment, overall planning and organizational leadership, and focus on training the frontier trends of the discipline development, the latest inspection technical standards, and the latest research results in this professional field at home and abroad.
Article 22 The training of inspectors shall be carried out in the form of a combination of centralized training and individual self-study. It can also be carried out in the form of online teaching, special seminars, inspection and observation, and base training. Inspectors shall participate in no less than 60 class hours each year. Education and training.
Article 23 The inspection center formulates scientific assessment standards according to the training content. The training effect can be evaluated in various forms such as written test, defense, online test, and on-site practical operation.
Article 24 The training and assessment results serve as an important indicator for the inspectors' annual assessment, priority evaluation, and level assessment. Those who fail the training and assessment in the current year and whose annual training time does not meet the requirements shall not be determined as excellent in the annual assessment, and shall not be promoted to the next level in the current year.
Article 25 The inspection center shall evaluate the situation of education and training, including training design, teaching content, teaching staff, organization and management, infrastructure, etc.
Article 26 The inspection center shall establish a complete file of inspector education and training, and truthfully record inspector education and training information, training methods, training hours, assessment results, training evaluation, etc.
 
Chapter VIII Examination Core

Article 27 Inspectors conduct annual assessments, take the job responsibilities of the inspectors as the basis for assessment, and focus on performance contribution, and conduct daily assessments and year-end assessments, ability assessments and