CNDSN August 31st] (first financial network) after nearly a month of self-examination, the State Food and Drug Administration released a 28 day clinical trial data and report results: the drug clinical trials involving 1622 varieties. Among them, the applicant submitted to the registration application for registration of 1094, accounting for 67%; the initiative to withdraw the registration application for 317, accounting for 20%; the application of the clinical trial, etc. do not need to submit registration applications for 193, accounting for 12%.

July 22nd, the food and Drug Administration released the drug clinical trial data on the verification of self-examination and verification (2015 117th), drug clinical trial data self-examination and reporting work in August 25, 2015 24, the end.

In August 18th, the State Food and Drug Administration held a televised conference call again, again reiterated the importance of the drug clinical trials self-examination.

Food and drug administration deputy director Wu Zhen stressed that encourage enterprises to carry out serious and responsible to carry out self-examination, the initiative to withdraw the registration of defects, and severely punish registration fraud behavior; to resolutely implement the two unchanged and three strict policy, namely: self inspection and closing time unchanged, allowing the main move to withdraw the policy unchanged, strict supervision, strict social supervision, strict verification requirements. August 25, 2015 24 points, the General Administration will be on time to close the self reporting system, no longer accept any form of reporting information. Failed to submit a report on the timely submission, will no longer continue to carry out technical review, directly to the decision not to approve. For August 25 days neither submitted to the report and other relevant information, and not active withdrawal of registration application, the General Administration will be returned to its application and the list of enterprises, after August 25th, the General Administration will announce the list of applicants, and the verification found that the real problem of the investigation, the relevant persons responsible for the publication of the society announced the applicant and the relevant responsible person list. Of the 1622 drugs involved in the registration announcement, where to be approved, must undergo clinical trials data verification. To do not cooperate with the verification, are judged to be not approved, the registration application is not approved.

In the self inspection results, there are 10 applicants performed neither submitted data also did not take the initiative to withdraw the self registration. The 10 applications are: Beijing Yinjian Pharmaceutical Co. the company declared Sertraline Hydrochloride Dispersible Tablets (admissibility: CXHS1000009), strong dragon kidney slices Beijing Guoyitang Pharmaceutical Co. Ltd. (Declaration of Acceptance Number: CXZS0600096), Hunan star sword Pharmaceutical Group Co. the company declared Jiangtangning tablets (admissibility: CXZS0601661), Jiangsu. The application of biological purification of the reporting Polytron Technologies Inc Inactivated Hepatitis A Vaccine (Vero cells) (admissibility: CXSS0700056, CXSS0700057), Hualan Biological Engineering (Suzhou) Co., Ltd. Human Immunoglobulin declaration (admissibility: CXSS0800010, CXSS0800011), Roxithromycin Tablets Nantong Hui Ying Pharmaceutical Co. Ltd. (Declaration of Acceptance Number: CYHS0690372) Tongmai tablet, Shaanxi jinweisha pharmaceutical Co. Ltd. (Declaration of Acceptance Number: CXZS0504345), gyro China Gaoke Yinxie capsule Group Co. Ltd. and Chongqing southwest Synthetic Pharmaceutical Co Ltd (Declaration of Acceptance Number: CXZS0502251, Yantai Zhongzhou Pharmaceutical Co. Ltd. has been out of the declaration). The species as the authenticity of the clinical trials of doubt, according to "drug registration management measures" Article 154 of the relevant provisions, the State Food and Drug Administration of the registration applicant shall not be approved.

Food and Drug Administration said that the completion of the registration of drug registration application will be completed by clinical trial data verification. Resort to deceit verification problems found, timely investigation, the registration shall not be approved. 3

(original title: clinical trial data false food and Drug Administration: the application is withdrawn into the 2 drug registration)

Editor: small Shen

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