There are two main issues that come to mind: firstly, there is no separate regulation for clinical trial applications, thus authorities treat an application for clinical trial the same as for a marketing approval. Since the data requirement and review process are similar, both the authorities and companies need to go through a long process involving the provision and checking of much data. A large degree of the quality review is made during the application review process, which results in a longer process. Secondly, there are the dossier requirement, and safety and efficacy concerns. Also, the excessive and unique data requirements in China cause much extra work for applicants, sometimes resulting in withdrawal of the application. Currently, delayed approval is a result of quality standard inspections which take 3-5 months; excessive data requirements; review process involving bureaus of provincial and national level; and, the lack of sufficient human resources in approval departments.
