Introduction of Good Clinical Practice in China
Description
Since the standard of Good Clinical Practice（GCP）was established in China in 1998, the rights, safety, and well-being of clinical trial subjects have been better protected, and clinical trial data made more credible. China Food and Drug Administration (CFDA) has been reforming the oversight of clinical trials, has published a series of relevant Guidelines, and has established the “drug clinical trial registration and information disclosure platform” to make information more accessible to the public. All these actions have been making the clinical trials conducted in China more consistent with internationally recognized principles.
Biography
Minjie Gao
Center for Certification and Evaluation, Shanghai Food and Drug Administration
Minjie Gao is a drug inspector from Center for Certification and Evaluation, Shanghai Food and Drug Administration. She is an expert in Chinese laws and regulations about drug registration and drug clinical trials. She works on drug applications review and on-site inspections in Shanghai. She also conducts GCP inspections for CFDA. To promote the efficacy of routine work, she and her colleagues have conducted a series of related studies on, for example, supervision of clinical trials, pharmaceutical pre-approval inspections, and regulatory policies of excipients. She graduated from Fudan University, School of Pharmacy, majoring in pharmaceutical analysis. Now she is a visiting scholar at Georgetown University Law Center.