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China rejects 30 drug applications due to data fabrication

Xinhua, October 22, 2016 Adjust font size:

China's drug safety watchdog has rejected 30 new drug registration applications due to fabrication of clinical trial data, it said.

"As of the end of September, 117 registration applications had been verified, 30 of which were rejected due to defects with authenticity, accounting for about 2 percent of the total registration applications for self-examination and verification," an official with the China Food and Drug Administration (CFDA) told Xinhua Friday.

In addition, 27 applications, 11 clinical trial institutions and Contract Research Organizations suspected of providing fraudulent data have been investigated since the CFDA organized the verification for registration applications under review in October 2015, the official said.

Before that, in July 2015, the CFDA required 1,622 drug registration applicants to perform self-examinations on the authenticity, integrity and compliance of clinical trial data, and applicants could voluntarily withdraw registration applications with problematic clinical trials and reapply after supplementing their dossiers.

A total of 193 registration applications were exempted from clinical trials, the official said. Another 1,429 applicants conducted self-examination, and of those, 1,193 applicants voluntarily withdrew their applications following self-examination, accounting for 83 percent of the total, according to the official.

The official noted multiple reasons for voluntary withdrawal.

"Some were for noncompliance with the Good Clinical Practice standards, which could affect the scientificness and accuracy of the clinical trial results," the official said, adding that others were for incomplete data that were insufficient to demonstrate drug safety and effectiveness, and still others were for untruthful data, some of which cannot be excluded as fraudulent.

Voluntary withdrawal by companies is not solely attributable to data fraud and reports that "80 percent of China's clinical trial data are fraudulent" by some media are not fact-based, the official continued.

Self-examination and verification of clinical data and cracking down on data fraud are aimed at encouraging innovation and creating a favorable environment for fair competition in order to ensure the safety and effectiveness of drugs approved for the market.

The entire self-examination process and verification of drug clinical trial data are transparent and open, and 21 announcements have been made by the CFDA to inform the public of progress in this area, the official said, adding that everyone is welcome to visit the CFDA website. Endi