China’s High Court Pushes for Severe Penalties for Falsifying Device Clinical Trials

China’s high court called for severe criminal punishments for deliberately falsifying medical device clinical trial reports and other related documents, issuing a judicial interpretation that takes effect Sept. 1.

The Supreme People’s Court of China specified the interpretation would apply to non-clinical research institutions, clinical trial institutions, contract research organizations and their staff, and that submitting false documents to the Chinese Food and Drug Administration would constitute material fraud.

In addition, the use of fraudulent drug approval documents in the production and sale of fake drugs — as well as deliberate use of the drug in non-clinical and clinical studies — would also carry strict punishments, the court said, naming five years’ imprisonment, fines and provisions for heavier penalties.

In a statement, the CFDA said the measure will be a powerful deterrent to application materials fraud. The interpretation also included pharmaceutical studies, data and registrations.

The high court’s judicial interpretation, in Chinese, is available here: www.court.gov.cn/zixun-xiangqing-55952.html. — Conor Hale