China FDA Frames Sanctions for Data Falsification

September 1, 2016

Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says.

In a draft guideline released last week, the Chinese FDA clarifies the penalties drug sponsors, clinical investigators, and clinical trial institutions will face when the agency identifies instances of data falsification, according to a summary by law firm Ropes & Gray.

The responsibility ultimately falls on drug sponsors, the summary states, but clinical research sites will also be held liable for forged clinical data used in drug applications.

The Chinese FDA will not only blacklist sponsors and research institutions involved in data manipulation, but clinical investigators as well. Clinical trials will be immediately suspended too.

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