Notice of the State Food and Drug Administration on the clinical trials conducted by drug clinical trial institutions and contract research organizations (No. 172, 2015)

Source: CFDA 2015-9-11 on August 25, 2015, the State Food and Drug Administration issued the notice on self inspection of clinical trial data of drugs (No 169 in 2015), and 1094 varieties submitted self inspection data The State Food and Drug Administration will verify the involved clinical trial institutions (hereinafter referred to as clinical trial institutions) and contract research organizations (cros) The relevant information is hereby announced as follows: 1 82 clinical trial institutions (see Annex 1) undertake human bioequivalence test and phase I clinical test, among which 7 clinical trial institutions undertake more than 20 bioequivalence tests and phase I clinical tests, respectively, Xiangya Third Hospital of Central South University (63 Item), the Second Affiliated Hospital of Liaoning University of traditional Chinese medicine (52 items), the Second Affiliated Hospital of Suzhou University (40 items), the First Affiliated Hospital of the Fourth Military Medical University of the people's Liberation Army (39 items), the Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology (31 items), the Affiliated Hospital of Liaoning University of traditional Chinese medicine (22 items), and the Affiliated Hospital of Changchun University of traditional Chinese medicine (20 items) II There are 383 clinical trial institutions undertaking phase II and phase III drug clinical trials (see Annex 2), among which 13 clinical trial institutions have undertaken more than 60 items, including West China Hospital of Sichuan University (114 items), the first hospital of Jilin University (73 items), the First Affiliated Hospital of Zhejiang University Medical College (70 items), Beijing Union Medical College (69 items) Item), the first hospital of Peking University (68 items), the people's Hospital of Peking University (68 items), Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College (68 items), the First Affiliated Hospital of the Fourth Military Medical University of the people's Liberation Army (66 items), the First Affiliated Hospital of Nanjing Medical University (66 items), Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and Technology (65 items) The Second Affiliated Hospital of the Second Military Medical University of the people's Liberation Army (61), the First Affiliated Hospital of Tianjin University of traditional Chinese medicine (61) III 126 cros (see Annex 3) undertake clinical trials, of which 6 cros undertake more than 20 clinical trials, including Guangzhou Boji new drug clinical research center (70), Shenyang Yiling Pharmaceutical Technology Co., Ltd (46), Anhui Wanbang Pharmaceutical Technology Co., Ltd (41), Shanghai kairuis Biotechnology Co., Ltd (28) Item), Beijing Wanquan sunshine Medical Technology Co., Ltd (27 items), Hangzhou tiger Medical Technology Co., Ltd (22 items) IV The State Food and Drug Administration will verify the clinical trial data of the clinical trial institutions and cros involved in the self-examination data, and handle the clinical trial institutions and cros with authenticity problems according to the requirements of Announcement No 117 of 2015 The State Food and drug administration shall track down all the data of clinical trials of drugs previously completed by it If it is found that there is fraud in the clinical trials of approved production or imported varieties of drugs, the drug approval number of the manufacturer shall be revoked, the qualification of the drug clinical trial institution shall be revoked, and the person directly responsible and the relevant personnel shall be investigated for their responsibilities V before verification by the State Food and drug administration, the clinical trial organization or CRO Self inspection shall be carried out actively If any untrue problem is found, the situation shall be reported to the drug and cosmetic registration department of the State Food and drug administration, and the applicant shall be urged to return the application actively The State Food and drug administration shall publish the list of returned applicants and products, and shall not check and file the case for investigation 6 In case of fraud against the applicant, clinical trial institution and cro, researchers and medical personnel are welcome to report to the administrative matter acceptance service and complaint reporting center of the State Food and drug administration through 12331 telephone or Internet The State Food and drug administration shall reward those who report meritorious deeds It is hereby announced Annex: 1 The situation of undertaking human bioequivalence test and phase I clinical trial 2 The situation of undertaking phase II and phase III clinical trial 3 The situation of undertaking clinical trial by cro Annex 1 Xlsx Annex 2 Xlsx Annex 2 Xlsx 2015 172 Bulletin 3.xlsx