China Clinical Trials Update

The China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, which outlines the entire clinical trial process for drug developers. The guide provides a comprehensive overview of the drug development process, including fundamental ethical principles and more detailed information about designing and running various types of trials. This publication is a step toward reducing the fraud and low quality standards recently seen in Chinese clinical studies.

The CFDA’s Center for Food and Drug Inspection (CFDI) has also released a notification in January 2017 for its plans to conduct on-site clinical trial inspections for 31 filings related to 23 drugs. Several major drug products new to the Chinese market include pharmaceuticals by multi-national companies such as Johnson & Johnson, Sanofi, and GlaxoSmithKline. Additionally, the CFDA officially released its database of random drug inspections. This database includes drugs that were found to be substandard, 60% of which were traditional Chinese medicine therapies.