In order to implement the requirements of “carrying out skills training around professional inspector team construction”, to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the third experts’ forum on April 26, 2018. At this forum, Doctor Sun Zhigang was invited to give a lecture on “New measures of drugs review and approval of FDA: Integrated evaluation of drugs quality review and inspection of production facilities”.

Doctor Sun has rich experiences in theory and practice in the aspect of drugs review and approval and production inspection, he had ever worked in FDA for 12 years in USA, being the Senior Drugs Reviewer and Group Review Leader of OGD, Acting Director of Processing Review II of OPQ, and Acting Drugs Assistant Director of FDA Beijing Office. At present, Doctor Sun is the Vice President of Regulatory Affairs of Sun Pharmaceutical Industries Ltd., mainly in charge of the registration application of generic drugs and new drugs in American market, and the change and maintenance of approved drugs.

Based upon the current situation and challenge of drugs quality supervision in USA, and reform of drugs supervision system of FDA, Doctor Sun illustrated the background of drugs quality review and integrated evaluation of inspection of production facilities, after clearly explaining the operating mode of integrated evaluation of drugs quality according to the expert team and risk assessment, he analyzed the risks and common defects in the processing and integrated review of facilities. With his own works in FDA, Doctor Sun comprehensively introduced the practice and experience in quality review and integrated evaluation of facilities inspection of FDA, and shared his own individual experience in integrated review and inspection. Because of his rich working experience and detailed explanation, the attendees and inspectors understood the rationality of effective integration of review and inspection, and sufficiently realized the necessity of drugs review and approval based upon the risk assessment, which was of significant reference and meaning for inspectors’ work in the future.

Center for Drug Evaluation, the Chinese Pharmacopoeia Commission, CFDI, the Center for Drug Certification of Beijing, the Center for Drug Review of Beijing and over 80 drugs inspectors of GMP and 25 provincial drug inspectorates from the whole country synchronously watching through video system participated in the training, totally 450 person participated in the training.