Study Flaws, Data Integrity Issues Clog China Review System As Applications Soar

Total Filings Processed Up 33%

Facing a 40% increase in investigational new drug applications, regulatory reviewers in China are scrambling to turn down hundreds of filings plagued by major study design flaws, inconsistent samples and quality control failures.

China growth
CHINA NEW DRUG FILINGS SOAR BUT DATA AND STUDY ISSUES REMAIN • Source: Alamy

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