On November 7-8 and 10-11, 2016, DIA collaborated with the FDA Office in China, Center for Food and Drug Inspection (CFDI) and the European Medicines Agency (EMA) to jointly hold the seminar of GCP inspection and data reliability respectively in Beijing and Shanghai. Twenty experts from FDA, CFDI, EMA as well as the domestic and foreign enterprises and the institutions of clinical trial made speeches on drug clinical trial supervision, data reliability and the bioequivalence study, and discussed and exchanged with the participants. More than 500 clinical supervision personnel and researchers from the provincial drug regulatory departments, drug clinical trial institutions, CRO and pharmaceutical companies in the domestic attended the seminar.

Ding Jianhua, director of the CFDI attended the opening ceremony of the training class in Shanghai and addressed. Ding pointed out that drug clinical trial is an important part of drug clinical research, and the reliability of clinical trial data is the basis for drug evaluation. On July 22 last year, CFDA initiated a landmark self-examination and inspection work of drug clinical trials data. It’s found that there are many GCP violations in the process of clinical trials through the inspection, and individual variety even had the problem of data authenticity. CFDA expected to make self-improvement through the analysis of the existing problems and causes, face the realities with rational attitude of openness, cooperation and communication, create a good research and development environment, improve the quality of clinical trials, and protect and promote public health.

In addition, Li Jianming, Deputy Director, Dong Jiangping, Deputy Director, as well as Zhang Rong, GCP inspector of the CFDI, also made speeches on the review and outlook of GCP in China, inspection of drug clinical trial data, analysis of issues and other hot topics in the industry.