From October 20 to 21, 2016, the Center for Food and Drug Inspection (CFDI) of CFDA and the China Center for Food and Drug International Exchange successfully held China-Japan drug GCP inspection seminar in Beijing.

This seminar invited Mr. Makoto Hirose, Director of Non-clinical and Clinical Compliance Office of Pharmaceuticals and Medical Devices Agency (PMDA) and three GCP inspection experts to interpret and analyze relevant regulations, inspection system and inspector training of Japan GCP in detail. Dong Jiangping and Li Jianming, Deputy Directors of the Center for Food and Drug Inspection presented the seminar and made speeches at the beginning and end of the seminar respectively.

More than 150 trainees from all provincial drug inspection institutions and all hospitals throughout China and personnel from Division of Research Inspection of CFDI and Division of International Inspection participated in this seminar.

In the morning of October 21, the Deputy directors and partial inspectors of CFDI and experts from PMDA held a closed-door meeting to deeply exchange on the supervision of China-Japan clinical trials, specific implementation conditions of inspection and relevant problems that both sides were interested in.

This seminar enabled trainees to fully and clearly understand the implementation and supervision inspection conditions of Japan GCP and shared Japanese peers’ experience on GCP on-site inspection and inspector training. The seminar achieved the expected effect. As a member of ICH, the drug supervision system of Japan, including management experience on clinical trials, has great reference meaning for China’s GCP supervision and data inspection work.