Falsifying drug regulatory submission may be a criminal offence in China

David Shen

In China’s latest effort to limit substandard drugs being approved using falsified clinical and non-clinical data, the Supreme People’s Court and the Supreme People’s Procuratorate jointly issued Judicial Interpretations that expressly provide that falsifying a drug regulatory submission may be a criminal offence which can be sanctioned with a penalty of up to 10 years imprisonment.  The Judicial Interpretations will be effective as of 1 September 2017 and will be binding on all Chinese courts.

According to the Judicial Interpretations, so-called “implicated people” of non-clinical research institutions, clinical research institutions or contract research organisations (CROs) which intentionally provide false research or clinical trial reports for drug registration, shall be liable for the crime of “deliberately providing false documents” under Article 229 of the Criminal Law. Similarly, drug registration applicants (i.e., pharmaceutical companies) “directing” such institutions to provide false documents shall be jointly liable for the same crime.

We believe the Judicial Interpretations will help reduce falsified drug registration documents. In addition, as a drug registration dossier can be a great of source of evidence for pharmaceutical patent infringement cases (especially for enforcing process and formulation patents), this development may also facilitate pharmaceutical patent enforcement.

The Judicial Interpretations provide further details and clarifications with respect to the relevant circumstances and sanctions, which we further discuss here.




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