In July 2015, the self-examination and verification of drug clinical trial data was officially launched. In July 2015, the CFDA issued the "Announcement on the Implementation of the Self-inspection and Verification of Drug Clinical Trial Data", requiring the 1,622 declared production or import pending review listed in the announcement The self-inspection and verification of drug clinical trial data is carried out in the drug registration application, which marks the official launch of the self-inspection and verification of drug clinical data. Subsequently, CFDA issued 29 announcements successively to guide and notify the development of self-examination and verification of clinical trial data.

Drug clinical trial data self-inspection verification process: first self-inspection, then clinical trial data self-inspection verification is divided into two steps: applicant self-inspection and CFDA verification. ① Self-inspection process: According to the CFDA public list, relevant applicants conduct self-inspection of clinical trial data on the registration applications that have been applied for production or import. After self-inspection, if there is a problem with the authenticity of the data, the registration application shall be withdrawn voluntarily; if no problem is found, it shall apply to CFDA for on-site verification. ②Verification process: According to the varieties applied for on-site verification, the verification team publicizes the on-site verification plan and conducts on-site verification, and then adopts a blind review method to conduct centralized review of the verification results. If the clinical data is found to have authenticity problems, the registration application will not be approved; if no problems are found, it will enter the normal review and approval process.

Self-inspection results: more than 60% of applicants voluntarily withdrew registration applications, reducing the pressure of CDE review. At present, CFDA has issued 9 announcements, requiring self-inspection and verification of clinical trial data of 2116 pending drug registrations that have been declared for production or import jobs. As of the end of June 2017, in addition to 258 registration applications that do not require verification, such as application for exemption from clinical trials, 1,316 registration applications were withdrawn voluntarily by the applicant after the self-inspection of drug clinical data, accounting for 62.2%; only 542 varieties need to be on-site Verification. This greatly eases the review pressure of CDE in applying for registration of production or import.

Verification results: Approximately one third of the registration applications in the 13-phase on-site verification plan have been reviewed as of August 2017. The CFDA Audit and Inspection Center has released a total of 13-phase drug clinical trial data on-site verification plans, with a total of 382 varieties. Among them, 42 enterprises withdrew their registration applications, CFDA approved 43 imports, approved 18 production, approved 5 clinical applications, 8 disapproved, and 266 had no review conclusions. In other words, 30.3% of drug registration applications that have already reviewed and approved results, and 69.7% of drug registration applications have no review conclusions.

As of June this year, 60% of the drug verification work has been completed. As of the end of June 2017, 313 of the 542 varieties to be verified have been verified, accounting for 57.7%. Among the checked drug registration applications, 94 were new drug registration applications, 37 were generic drug registration applications, and 182 were imported drug registration applications. Among them, a total of 38 varieties are suspected of falsifying clinical trial data, and the suspected falsification of clinical trial data for generic drug registration applications is the most serious.

Main problem: Most of the defects in the clinical part, the problems are more concentrated. According to the on-site inspection report of 313 drug registration applications, a total of 5111 defects were found, including 4583 in the clinical part and 528 in the biological analysis part. The defect items were classified, and many problems were found in clinical trial process records, clinical inspections, laboratory tests and other data traceability, protocol violations, experimental drug management processes and records, and safety records and reports, accounting for 61.8%.

Risk reminds the sustainability risk of drug clinical trial data self-examination and verification work; implementation is lower than expected;