FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

China’s FDA Verifies Data from 55 Clinical Trials in First Wave of International Audits

Nov. 16, 2016
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As part of its clinical trial data auditing initiative, the Chinese Food and Drug Administration verified data from an initial set of 55 clinical trials, focusing mainly on large, international drugmakers.

Divisions of Astellas Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Ferring Pharmaceuticals, GE Healthcare, Janssen, Merck, Novartis, Sanofi-Aventis, Sumitomo, Takeda and their products were listed as verified imports by the CFDA. The agency, employing 73 verification teams, also confirmed data from six generic applications, one new drug, and one supplementary application from Chinese companies.

In July 2015, the CFDA announced that all pending and future drug applications and trial data should be in accordance with good clinical practices, and said that applicants may self-examine their data and withdraw applications if it is found to be false.

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