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临床数据造假入刑(línchuáng shùjù zhàojiǎ rùxíng):Fabrication of clinical trial data carries legal liabilities

China Daily | Updated: 2017-04-14 07:28

For the first time, the Supreme People's Court has approved a judicial interpretation that clarifies fabrication of clinical data to win approval for pharmaceutical drugs carries legal liabilities, with those found guilty of the charge subject to the death penalty.

China's Drug Administration Law and the Regulation for Implementation of the Drug Administration Law both stipulate punishments for the fabrication of pharmaceutical drug clinical trial data. The punishments include warnings, orders to make corrections within a certain time limit, orders to cease production, stop doing business for internal rectification and being included on a blacklist. These punishments are all administrative penalties that mainly target organizations.

This time the Supreme People's Court clarifies that the fabrication of clinical data carries legal liabilities for individuals.

The fabrication of clinical data is a serious problem in China's pharmaceutical drug research and development, because of the loopholes in pharmaceutical drug trials and the lax supervision.

According to the Chinese Journal of Clinical Pharmacology's statistics, 85.7 percent of the clinical trial records for pharmaceutical drugs were not standardized.

The fabrication of clinical data can endanger life. The Supreme People's Court's new judicial interpretation is expected to act as an effective deterrent, and so reduce the prevalence of clinical data fabrication.

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