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CFDA: 80% of China's Drug Applications Utilized Faulty Data

publication date: Oct 4, 2016
According to an investigation conducted by the CFDA, 80% of the applications for new drugs in China reviewed in this report utilized compromised data. The results contained fabricated or fraudulent numbers, omitted adverse events, offered incomplete or missing source documents, or other infractions. However, no drugs were believed to be approved based on this faulty data, as the subject applications were either withdrawn by the sponsor or rejected by the CFDA. The CFDA closely examined the clinical data from 1,622 new drug applications to arrive at the 80% failure rate. In the case of generic drugs, data was simply made up to prove bioequivalence in 90% of the cases, according to the CFDA report, which was released in the Economic Information Newspaper, a state-owned organ.  More details....

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