There have recently been dramatic changes on government regulations in drug development in China. For instance, the China Food and Drug Administration (CFDA) recently revised its Provisions for Drug Registration (PDR) requiring no prior overseas approval for new drug application in China. Under the new version of PDR, many technical guidelines governing drug development and approval processes are expected to be revised. With the CFDA becoming an official member of the International Conference on harmonization (ICH) in June 2017, it is expected that the regulatory requirements for drug development and approval in China will soon follow the ICH guidelines. However, due to many different reasons (e.g., disease etiology and prevalence, medical practice, etc.), the requirements for IND and NDA could differ from other ICH regions or countries. This tutorial will cover the following aspects:
(1) An overview of biopharmaceutical research, development and regulation in China
a. Biopharmaceutical industry – Multi-national and domestic
b. Functionality and structure of CFDA
c. Drug Administration Law, PDR and technical guidelines
(2) An overview of drug approval process
a. Domestically innovated drugs
b. Imported drugs
(3) Introduction to the new PDR
(4) Statistical guidance for clinical trials
a. Design considerations
b. Analysis considerations
c. Data monitoring
(5) Guideline for multi-regional clinical trials;
(6) General considerations for clinical trial applications (IND)
a. China alone studies
b. China to join MRCTs
(7) General considerations for new drug applications (NDA)
a. Drugs targeting China prevalent diseases
b. Drugs targeting rare diseases
During the discussion, numerous examples will be given for different circumstances in both IND and NDA.
Naiqing Zhao, Professor, Department of Biostatistics, School of Public Health, Fudan University, China. Prof. Zhao’s experience spans from the design and analysis of clinical trials, clinical epidemiology, biological signaling, to statistical methodology research in biomedical field. He has been teaching biostatistics for over 20 years and serving as an external review expert of clinical trial statistics for the China Food and Drug Administration for more than a decade. Prof. Zhao received a Bachelor degree in mathematics from Fudan University and a Master's degree in biostatistics from the University of Newcastle, Australia.
Jie Chen, Distinguished Scientist, Merck Research Laboratories, North Wales, Pennsylvania. Before rejoining Merck, Jie held various positions in biopharmaceutical companies including six-and-a-half-year experience in China and prior 14 years at Merck Research Laboratories in the US. Jie’s experience includes clinical trial design and data analysis, statistical methodology research and applications in non-clinical, pre-clinical and clinical development, as well as safety evaluation in both clinical and post-approval settings. Jie received an MD from Shanghai First College of Medicine (now Fudan University College of Public Health), Shanghai, China, and a PhD from Temple University, Philadelphia.