Health and Family Planning Commission and State Administration of Drug Administration: Notice on carrying out the filing work of stem cell clinical research institutions

Source: National Health and Family Planning Commission of the people's Republic of China, 2015-12-07 National Health Office, kejiaohan [2015] No 1071, health and Family Planning Commission and food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government, Health Bureau and food and Drug Administration of Xinjiang production and construction Corps: In order to promote the implementation of measures for the administration of stem cell clinical research (Trial Implementation) and guiding principles for the quality control and preclinical research of stem cell preparations (Trial Implementation), strengthen the management of stem cell clinical research institutions, effectively implement the main responsibilities of stem cell clinical research institutions, ensure that qualified medical institutions carry out stem cell clinical research in a standardized way, and promote stem cell clinical research The national health and Family Planning Commission and the food and Drug Administration will speed up the filing of stem cell clinical research institutions The specific notice is as follows: 1 The applicant shall meet the requirements of Article 7 of the administrative measures for stem cell clinical research (Trial) 2 Application materials (1) meet the requirements of Annex 1 of the administrative measures for clinical research of stem cells (Trial) The specific materials are as follows: 1 Photocopy of practice license of medical institutions; 2 Photocopy of qualification certification of drug clinical trial institutions; 3 Organization and management system of stem cell clinical research (framework chart) and responsibilities of each department; 4 Qualification of main responsible person and quality authorized person of organization stem cell clinical research management and training of relevant personnel; 5 Composition of Academic Committee and ethics committee of organization and their working system and standard operation specifications; 6 Standard operating procedures for stem cell preparation, facilities, equipment and personnel conditions; 7 Quality management and risk control procedures and relevant documents for stem cell clinical research (including quality management manual, clinical research work procedures, standard operating specifications and test records); 8 Audit system for stem cell clinical research, internal and external audit systems, and internal auditor qualification; 9 Stem cell quality evaluation standards and testing equipment and facilities; 10 Prevention of stem cell clinical research risk management mechanism and measures to deal with adverse reactions and adverse events; 11 Other relevant information (2) supporting materials and relevant information of the project of stem cell research at the national or provincial and ministerial level hosted or as the main participating unit 3、 Application procedures (1) the two committees and bureaus of each province (region, city) shall organize the application of the local stem cell clinical research institutions in accordance with the requirements of the administrative measures for stem cell clinical research (Trial) and the guiding principles for quality control and preclinical research of stem cell preparations (Trial) (two) the applicant shall submit the application materials (printed and bound on both sides of A4 paper) in two copies and 2 electronic CDs to the scientific research management department of the provincial (District, city) health and Family Planning Commission, which shall jointly review with the food and drug administration (III) the provincial (District, city) health and Family Planning Commission shall submit the application materials reviewed by the provincial two committees and bureaus in one copy and one electronic disc to the Secretariat of the national stem cell clinical research expert committee before December 10, 2015 (address: room 1013, 10 / F, building 2, Guangqu Jiayuan, Dongcheng District, Beijing 100022, contact number: 010-62115986) (4) the national stem cell clinical research expert committee is entrusted by the national health and Family Planning Commission and the food and drug administration to conduct technical examination on the application and filing materials The state health and Family Planning Commission and the State Food and Drug Administration will publicize the filing institutions Institutions with no objection can be registered in the medical research registration information system for stem cell clinical research institutions Stem cell clinical research projects shall be implemented in the institutions that have been put on record Contact: Yin XuKe, Wang Jinqian, Department of science and education, national health and Family Planning Commission Tel: 010-68792955 Fax: 010-68792955 contact: Chang Weihong, pharmaceutical registration department, food and Drug Administration Tel: 010-88330713 Fax: 010-68316572 general office, general office of food and drug administration, general office of national health and family planning Commission Dec 2015 1 June