Be careful! 17 drug registration applications are about to be verified with drug clinical trial data

According to the work procedure for data verification of drug clinical trials of the State Food and Drug Administration (Provisional) (sfjyhg [2016] No 34) and the relevant work requirements of the State Administration on accelerating data verification of drug clinical trials, the verification center plans to carry out on-site verification on 17 drug registration applications (Appendix 1), including human prothrombin complex (acceptance No.: cxss1700024), etc 。 The publicity period is 10 working days, from May 6, 2019 to May 17, 2019 After the publicity period, on-site inspection shall be arranged The relevant matters are described as follows: 1 The applicant for drug registration shall submit one copy of the application materials for clinical trials of the above varieties to our center according to the requirements of the application materials for clinical trials of drug registration, and attach a catalog 2 If the applicant for drug registration has supplemented and submitted the relevant data of clinical trial to the drug review department in the process of variety review, he / she shall submit the relevant supplementary data together with the letter of supplement issued by the drug review department 3 When submitting the application materials, the drug registration applicant shall sign and submit a letter of commitment (Annex 2) to ensure that the submitted application materials related to clinical trials are true and complete, and consistent with the application materials related to clinical trials accepted by the drug evaluation department 4 The applicant for drug registration shall, within 10 working days after the issuance of this circular, send the above clinical trial application materials and letter of commitment to the verification center Attention: clinical verification data group, unit name: Food and drug audit and inspection center of the State Drug Administration, address: floor 6, Beikuang financial building, building 3, No 1 hospital, Wenxing street, Xicheng District, Beijing, postcode: 100044, Tel: 010-68441500, fax: 010-68441300, contact person: Ning Jing, Jiang Bingqian Notice is hereby given Appendix 1: application directory for on-site verification and registration of drug clinical trial data.docx Appendix 2: letter of commitment.docx application directory for on-site verification and registration of 17 drug clinical trial data of food and drug audit and inspection center of State Drug Administration on May 6, 2019