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    Home > Medical News > Latest Medical News > Management Measures issued by the State Food and Drug Administration for key laboratories

    Management Measures issued by the State Food and Drug Administration for key laboratories

    • Last Update: 2020-01-06
    • Source: Internet
    • Author: User
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    Drug administration of all provinces, autonomous regions and municipalities directly under the central government, and Drug Administration of Xinjiang production and Construction Corps, all relevant units: In order to standardize the application and review, operation and management, assessment and evaluation of key laboratories of the State Drug Administration, and improve the development ability and level of drug regulatory science and technology, the State Drug Administration has organized and formulated the measures for the administration of key laboratories of the State Drug Administration, which are hereby printed and distributed for implementation Article 1 of Chapter I general provisions of the measures for the administration of key laboratories of the State Drug Administration on December 31, 2019 is formulated to regulate the application, review, operation, management, assessment and evaluation of key laboratories of drugs (including drugs, medical devices and cosmetics) of the State Drug Administration (hereinafter referred to as key laboratories) Article 2 the construction of key laboratories shall adhere to the principles of urgent need, classified implementation, regional overall planning and reasonable layout, promote the scientific development of drug supervision, transfer and transformation of scientific and technological achievements, high-end personnel training, and improve the development ability and level of drug supervision technology Article 3 the main task of key laboratories is to face the frontier of pharmaceutical science and technology, focus on the strategic needs of pharmaceutical innovation and development and regulatory science, carry out original research and scientific and technological research in the field of pharmaceutical regulatory technology support, solve basic, critical, frontier and strategic technical problems, and accelerate the scientific, legal, international and modernization of China's pharmaceutical regulation Play an important role Article 4 the key laboratories shall implement the director responsibility system under the leadership of the supporting units and the operation mode of "open, mobile, joint and competitive", and adopt the management mechanism of "regular evaluation and dynamic adjustment" Article 5 key laboratories are mainly established by relying on the inspection and testing institutions of the drug regulatory system, or by combining the inspection and testing institutions of the drug regulatory system with institutions of higher learning, scientific research institutes and research institutions in related fields organized by social forces, or by relying on the construction of institutions of higher learning, scientific research institutes and research institutions in related fields organized by social forces Chapter II responsibilities and requirements Article 6 the State Drug Administration is the identification Department of key laboratories, whose main responsibilities are: (1) to formulate the management system of key laboratories and promote the strict implementation of key laboratories; (2) to formulate and organize the implementation of the overall plan of key laboratories and guide the construction and operation of key laboratories in a macro way; (3) To approve the establishment and cancellation of key laboratories; (4) to organize the evaluation and inspection of key laboratories Article 7 the Department of science, technology and international cooperation of the State Drug Administration is responsible for the evaluation, guidance, supervision and evaluation of key laboratories The State Drug Administration has set up a Key Laboratory Construction Management Office (hereinafter referred to as the management office), which is responsible for the acceptance and examination of application materials, review and defense, on-site verification of key laboratories, as well as the organization of supervision and evaluation Article 8 the main responsibilities of the provincial drug administration are: (1) to implement the relevant regulations of the State Drug Administration on the management of key laboratories, to support the operation and development of key laboratories, and to strive for local financial support; (2) to be responsible for the preliminary examination of the application qualifications of key laboratories in the administrative region; (3) To assist the State Drug Administration in inspecting, supervising and evaluating the operation and management of key laboratories in its own administrative region (4) To be responsible for the annual assessment of key laboratories in the administrative region (5) To be responsible for promoting the transfer and transformation of scientific and technological achievements of key laboratories in their respective administrative areas Article 9 the supporting unit is the responsible unit for the construction and operation management of key laboratories Its main responsibilities are: (1) to implement the relevant regulations of the State Drug Administration on key laboratories; (2) To be responsible for organizing the application and construction of key laboratories, and providing the corresponding site, personnel, instruments and equipment, operating funds and logistical support for key laboratories; (3) to be responsible for the appointment of the director of key laboratories, the director of Academic Committee and members of Academic Committee; (4) to be responsible for the standardized operation and management of key laboratories; (5) Cooperate with the State Drug Administration and the provincial drug administration in the supervision, inspection and evaluation of key laboratories Article 10 the director of a key laboratory shall be a fixed person of the supporting unit, a high-level academic leader in the field, with a senior professional and technical title and strong organizational and management ability, and in principle not over 65 years old Article 11 the main responsibilities of the director of the key laboratory include: to organize the formulation and implementation of the construction and development plan of the key laboratory, to formulate the research direction and research focus of the key laboratory around the needs of drug supervision, to take the lead in carrying out project research; to be responsible for the daily management of the key laboratory, to standardize the operation and use of funds of the key laboratory, and to organize the academic exchange of the Key Laboratory 。 Article 12 key laboratory personnel include fixed personnel and floating personnel, and the total number of personnel is generally no less than 20 Fixed personnel include researchers, technicians and managers The proportion of fixed personnel in the number of all personnel shall not be less than 70% The proportion of personnel with senior professional and technical titles in the number of all personnel shall not be less than 30% The floating population includes visiting scholars, postdoctoral researchers, etc Article 13 key laboratories shall establish academic committees The academic committee is the academic guidance organization of key laboratories Its main responsibilities include: participating in the formulation of the construction and development plan of key laboratories, guiding the research work of key laboratories, and evaluating the research results of key laboratories Article 14 the chairman of the academic committee of a key laboratory shall be a high-level academic leader in his field, with a senior professional and technical title and a strong organizational and management ability His main responsibility is to organize and lead the work of the academic committee The chairman of the academic committee shall not be a fixed person of the supporting unit (including the participating unit) The same person is not allowed to serve as the director of Academic Committee in more than 2 (excluding 2) key laboratories at the same time Article 15 the members of the academic committee of key laboratories shall be composed of domestic and foreign excellent experts in the fields of drug supervision and management, inspection and testing The total number of members shall be an odd number, generally no less than 7 and no more than 15 Among them, the number of members belonging to the fixed personnel of supporting units (including participating units) shall not exceed one third of the total number of members Members shall have senior professional and technical titles In principle, they shall not be more than 70 years old, and the number of members under the age of 45 shall not be less than one third of the total number of members The same person is not allowed to serve as a member of the academic committee in two or more key laboratories at the same time Chapter III Application and evaluation article 16 qualification of key laboratories shall be determined by evaluation method, and the evaluation shall be carried out in accordance with the principle of "voluntary application and evaluation based on merit" The State Drug Administration issues the application notice according to the needs of drug supervision, and the supporting units organize the application for key laboratories according to the requirements of the notice The State Drug Administration shall organize centralized review Article 17 pharmaceutical inspection and testing institutions affiliated to the pharmaceutical supervisory and administrative departments, institutions of higher learning, scientific research institutes and research institutions in related fields organized by social forces that meet the following basic conditions may apply to be the supporting units of key laboratories (1) It is established in accordance with the law within the territory of the people's Republic of China and can independently bear legal liabilities (2) There is a clear construction and development plan, the research direction is in line with the needs of drug regulatory work, there is sufficient scientific research funding, and the management system is sound and running well (3) Inspection and testing institutions meet the requirements of class B and above in the guiding principles for capacity building of drug inspection and testing institutions, the guiding principles for capacity building of medical device inspection and testing institutions, and the guiding principles for capacity building of cosmetics inspection and testing institutions or have corresponding capacity building requirements (4) The research direction of the applied key laboratory has the domestic leading academic level and scientific research ability, as well as obvious characteristics or advantages It has presided over national or provincial (ministerial) scientific research projects and achieved high-level scientific research results, and has the ability to track international new technology and research leading technology (5) It has good ability and experience in transfer, transformation, popularization and application of scientific research achievements Article 18 when applying for a key laboratory, an independent application or a joint application may be adopted The drug inspection and testing institutions affiliated to the drug regulatory departments at all levels are encouraged to apply jointly with institutions of higher learning, scientific research institutes and research institutions in relevant fields organized by social forces All units applying for the joint application shall have the basis of cooperative research with the supporting units in the past five years, and have the output of scientific research achievements In principle, the number of units in joint application shall not exceed 3 The joint application shall identify one unit as the supporting unit and the other units as the participating units The conditions of the supporting unit shall meet the requirements of Article 17 After the key laboratory is identified, the supporting unit is responsible for leading the research, strengthening operation management and accepting assessment and evaluation Without the permission of supporting units, participating units shall not carry out work in the name of key laboratories alone Article 19 with the approval of the competent department, the supporting unit shall submit an application to the provincial drug regulatory department of the province, autonomous region and municipality directly under the central government, and submit the application letter and the application for key laboratories of the State Drug Administration (hereinafter referred to as the application) The provincial drug supervision and administration department shall preliminarily review the authenticity and integrity of the application materials and whether they meet the basic conditions of the supporting unit and the requirements of relevant personnel If the preliminary examination is passed, the provincial drug regulatory department shall report it to the administrative office Article 20 if the supporting unit is a unit directly under the State Drug Administration, the application letter and application letter shall be submitted directly to the administrative office, which shall be responsible for the preliminary examination Article 21 Defense Review The management office reviews the application materials of key laboratories If it passes the examination, experts shall be organized to review the defense According to the principles of subject matching and avoidance, some experts are randomly selected from the review expert database, some are recommended by relevant departments and directly affiliated units of the State Drug Administration to form a defense team, and the list of experts is strictly confidential In principle, the defense group is composed of 9-11 experts Each expert shall score independently in strict accordance with the evaluation index system of defense experts, and the team leader shall announce the scoring results on site Article 22 on site inspection The management office, in combination with the overall arrangement and deployment of key laboratories, studies and determines the basic principles and proportion of on-site inspection According to the basic principles and proportion of on-site verification, the management office determines the list of on-site verification, groups them according to discipline categories and regions, and organizes experts to carry out on-site verification The selection method of experts shall refer to the procedures and requirements for the selection of Defense Review experts, and priority shall be given to the experts participating in the Defense Review Each group of experts shall be no less than 3, and the list of experts shall be strictly confidential The expert group shall score according to the on-site inspection and evaluation index system and announce the scoring results to the applicant on site Article 23 comprehensive evaluation The management office shall calculate the total score of each key laboratory according to "Defense Review score × 60% + on-site verification score × 40%" The management office shall study and determine the basic principles and proportion for entering the comprehensive review, and propose the list of suggestions for entering the comprehensive review
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