摘要 : Before accepting the concept of assessing the suitability of extrapolating foreign clinical data to a new region during drug registration, many regulatory authorities requested duplicate data in support of registration due to conc... 展开 Before accepting the concept of assessing the suitability of extrapolating foreign clinical data to a new region during drug registration, many regulatory authorities requested duplicate data in support of registration due to concerns that ethnic differences might affect the medication's efficacy and safety in the new region. Taiwan is no exception. To eliminate redundant or unnecessary clinical trials and to better understand the ethnic sensitivities of a new drug, the International Conference on Harmonization (ICH) E5 guidance: Ethnic Factors in the Acceptability of Foreign Clinical Data (1) was adopted by the Department of Health (DOH) in Taiwan. 收起