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China to crack down on frauds of clinical test data
Online Edition
China's food and drug watchdog said Thursday it will severely punish acts of modifying and falsifying data from clinical tests in the future.
According to an announcement released by the China Food and Drug Administration, authorities would check the reports of clinical testing given by the applicants who had completed such testing and carried out self-examination of results as required.
An investigation would be launched into any case suspected of fraud, it said, adding the registration application of the drugs involved would not be approved.
The people and clinical testing institutions would be added to a blacklist with their information being publicized, said Li Maozhong, deputy director of the department of drug and cosmetics registration of the administration.
"If the applicants are suspected of committing crimes, their cases will be transferred to police for handling," Li said.
A report published by the administration on Wednesday said alleged fraud, including modifying and falsifying clinical testing data, were found in registration applications of 11 drugs submitted by 8 companies.
The administration asked all drug registration applicants to check their clinical test data to make sure they are reliable, according to Wednesday's report.
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