Training session on Traditional Chinese Medicine registration and administration successfully held in Shanghai
Under the guidance of the National Medical Products Administration and hosted by the Yangtze River Delta Centre for Drug Evaluation and Inspection of NMPA, a training session on Special Provisions for the Registration and Management of Traditional Chinese Medicines was successfully held on May 29th-30th in Shanghai. A total of more than 1,300 participants from Chinese medicine manufacturers, Chinese medicine R&D organizations, scientific research institutes and regulatory agencies registered for the training.
This training invited Wang Hainan, Deputy Director of the Department of Drug Registration, to make a policy interpretation of the Special Provisions on the Registration and Management of Chinese Medicines, Prof. Chen Pingyan of the Southern Medical University to make an interpretation of the Technical Guidelines for Clinical Research and Development of New Drugs Based on the Experience of People with Human Use of Chinese Medicines Compound Preparations, and the Minister of the Chinese Medicine Evaluation Department of the Center for Drug Evaluation and Review and evaluators made in-depth analyses of the technical requirements for the research of the pharmacology and pharmacology-toxicology of the Chinese medicines compound preparation with classical ancient prescriptions, the technical requirements for the research and development of new drugs with the same name and the same prescription and the application of new tools and methods in the collection and collation of human experience. Technical requirements for R&D of improved new drugs, application of human experience in R&D and registration of traditional Chinese medicines, and application of new tools and methods in collecting and organizing human experience were analyzed in-depth with case studies and answered on-site for the difficult questions encountered by enterprises in the R&D process. Participants expressed that the training was substantial, well interpreted, and fruitful.