In order to implement the requirements of “carrying out skills training around professional inspector team construction” of leading Party group of the CFDA, to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the second experts’ forum on March 21, 2018. At this forum, Doctor Yu Hong, Main Reviewer of the Center for Drug Evaluation of CFDA (CDE), made a speech about “Key Points of Technical Review on Chemical Drug and Pharmacy.

Doctor Yu Hong now acts as Main Reviewer and Chief Pharmacist of No. 1 Chemical Drug and Pharmacy Department of CDE, leads heart-kidney review team to mainly undertake main drug review work of circulatory system, kidney/urinary system and other indications. Doctor Yu briefly introduced registration classification and review procedures of medical drug, and presented pharmacy review strategies of innovative drug, generic drug, new technology and complex products, and explained review requirements on pharmacy technology of chemical drug mainly from drug production, characteristic authentication, quality control, packaging system and stability as well as other aspects in combination with requirements on chemical drug application materials. Director Yu’s explanation has not only helped participants to further understand review strategies and technical requirements regarding review of chemical drug, but also provided significant reference for relevant inspection of chemical drug.

Drug and Cosmetic Registration Office of CFDA, the Chinese Pharmacopoeia Commission, the Center for Food and Drug Inspection of CFDA, the Center for Drug Certification of Beijing, the Center for Drug Review of Beijing and 25 provincial drug inspectorates from the whole country synchronously watching through video system participated in the training, totally 440 person participated in the training.