title: [Closed-loop management model of clinical investigational product for new drug of traditional Chinese medicine].
abstract: This paper discussed the management regulations and technical requirements of clinical investigational product for new drug of traditional Chinese medicine, analyzed some common problems on the management of them, and proposed the establishment of closed-loop management model and management requirements in various aspects.
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. wp2115@163.com
authors.forename: Ping
authors.initials: P
authors.lastname: Wu
authors.affiliation: Beijing Food and Drug Administration, Beijing 100053, China.
authors.forename: Jian-Wu
authors.initials: JW
authors.lastname: Zhang
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004358:Drug Therapy; D004335:Drug and Narcotic Control; D004365:Drugs, Chinese Herbal / Q000592:standards / Q000627:therapeutic use*; D015507:Drugs, Investigational / Q000592:standards / Q000627:therapeutic use*; D006801:Humans; D054539:Medication Therapy Management / Q000592:standards*; D008516:Medicine, Chinese Traditional
chemical_list: D004365:Drugs, Chinese Herbal; D015507:Drugs, Investigational