China’s CFDA Orders Self-Inspections of Pharmaceutical Clinical Trial Data

The Chinese Food and Drug Administration (CFDA) has mandated that pharmaceutical companies with pending drug registrations must now self-audit their clinical trial data and submit their findings electronically to the CFDA by August 25, 2015.

1,622 drug registration applications, including 171 imported drug applications, have been required to submit a self-inspection report. Failure to submit a report will halt the approval process. Companies that are found to have omitted/falsified data or destroyed evidence will be banned from submitting drug registrations for the following three years. Pharmaceutical companies are, however, allowed to withdraw their registration applications before August 25 if they are unable to submit the self-inspection report. Companies filing drug applications after August 25 will be subject to inspections by provincial authorities as well as surprise inspections by the CFDA.

The CFDA has recently come under heavy criticism for its slow and inefficient drug review and approval process. Clinical trial data self-audits are just one measure the ministry has been taking to raise drug quality and address its backlog of 18,600 applications. Other policies expected to be implemented in the near future include: restricting the approval of redundant generic drugs; strengthening the technical review standards for generics; placing companies responsible for falsifying data onto a public blacklist; and fast tracking the approval process for drugs that are greatly needed, such as pediatric drugs.