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

Total Filings Processed Up 33%

 
• By Brian Yang

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

To find how prevalent problems are in regulatory filings to start clinical trials and for product approvals in China, one doesn’t have to read far within China’s annual report on new drug reviews, released on 21 June by the National Medical Products Administration (NMPA), to find out.

In 2020, the regulatory agency approved 20 innovative new products, including 14 drugs, four traditional Chinese medicines and two biologics....

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