China FDA official views new drug clinical trial data verification

An official from the Department of Drug and Cosmetics Registration of the China Food and Drug Administration (CFDA) was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications,” reported by media.

According to a summary posted on the CFDA website, the official explained that, according to the Announcement on Performing Self-Examination & Verification of Drug Clinical Trial Data issued on July 22, 2015 by CFDA, for 1,622 registration applications for marketing and import, the applicants had been required to do self-examination on the authenticity, integrity and compliance of clinical trial data. Deducting 193 registration applications exempted from clinical trial, the total number of applications for self-examination was 1,429. Applicants could voluntarily withdraw their registration applications with problematic clinical trial and reapply after supplementing their dossiers. By the end of June, 2016, 1,193 voluntary withdrawals happened after self-examination of the companies, accounting for 83% of the total number of registration applications for self-examination.

30 registration applications rejected due to defects with authenticity