In Taiwan, bridging study evaluation (BSE) is a process required before or with new drug application (NDA) for new chemical entities. The objectives of BSE are to assess whether the drug response in the target population among Taiwanese would be affected by intrinsic/extrinsic ethnic factors and whether the foreign clinical data can be extrapolated to the regional population. With few exceptions, BSE submissions without Asian clinical data would not receive a bridging study waiver. Therefore, a bridging study on Taiwanese or East Asian will be requested to resolve the ethnic concern arising from BSE in order to demonstrate the applicability of dose regimen in Taiwan.
With the globalization of drug development, multi-regional clinical trials (MRCTs) including Asian subjects have been widely considered by many pharmaceutical companies. There is an increasing trend in the use of MRCTs with an Asian subpopulation in the submission of BSE and NDA in Taiwan. Through this strategy, more and more new drugs were granted bridging study waivers and then approved in Taiwan. In this talk, the speaker will share regulatory viewpoints and review experiences of bridging study evaluations as well as MRCTs in Taiwan.
Guei-Feng Tsai is currently a statistical team leader at Division of New Drugs, Center for Drug Evaluation (CDE), Taiwan. The team supports all statistical aspects of regulatory submissions and consultation services in drugs and medical devices. She has worked in CDE for over 10 years. Prior to joining CDE, she served as a postdoctoral fellow in the Department of Statistics at Northwestern University. She obtained a Ph.D. in Statistics from Oregon State University. She earned an M.S. in Biometry and a B.S. in Agronomy from National Taiwan University.