Life sciences practice partner Katherine Wang (Shanghai) was quoted in an April 18 article in Pink Sheet on China’s top court’s plans to make clinical data forgery and similar violations criminal acts subject to legal punishment.
The China Food and Drug Administration (CFDA) said it is aiming for the highest standards, strictest enforcement, and severe punishments to ensure the safety of drug and medical devices. Existing problems with data integrity in product approval applications led the CFDA to launch a crackdown on clinical data violations in 2016, which led to the withdrawal of nearly 80 percent of the 1,622 new drug applications.
Ms. Wang explains that although China’s courts make the final judgment, CFDA's view of a clinical data forgery case will have a decisive impact, and courts will then decide on a penalty based on intention and other evidence.
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