title: The changing landscape of clinical trial and approval processes in China.
abstract: In the past decade, the standards of clinical trials in China have moved closer to international standards, thus encouraging the development of innovative drugs. However, a large backlog of pending applications for both drug approval and clinical trial registration has arisen owing to the complexity of the approval process, the volume of applications and a lack of staff available to process these applications, among other reasons. To improve the drug approval process, a 'four-colour-light' strategy was introduced. Different drugs are classified into redefined categories of innovative and generic drugs, with priority being given to approval decisions concerning innovative drugs. Other improvement strategies are now also being implemented, including the development of a new clinical trial approval system and several measures designed to encourage greater participation of Chinese researchers and research centres in international clinical trials. In this Perspective, the changing landscape of clinical approval in China is described, including the difficulties that drug approval authorities face in this rapidly developing nation and the novel strategies that are being used to find solutions.
authors.affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Zhou
authors.affiliation: Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA), 26 Xuanwumen Xidajie, Beijing 100053, China.
authors.forename: Xiao-Yuan
authors.initials: XY
authors.lastname: Chen
authors.affiliation: Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA), 26 Xuanwumen Xidajie, Beijing 100053, China.
authors.forename: Zhi-Min
authors.initials: ZM
authors.lastname: Yang
authors.affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China.
authors.forename: Yi-Long
authors.initials: YL
authors.lastname: Wu
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D002681:China; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D017277:Drug Approval / Q000458:organization & administration*; D006801:Humans; D012042:Registries
chemical_list: D000970:Antineoplastic Agents