30 new drugs rejected on falsified data
Print Edition
CHINA’S drug safety watchdog has rejected 30 new drug registration applications as clinical trial data was falsified, 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 has said.
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.
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 did self-examination, of which 1,193 voluntarily withdrew their applications, or 83 percent of the total, the official said.
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