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.