Abstract
In 2001, the Bridging Study Evaluation (BSE) review process based on the ICH E5 guideline was introduced in Taiwan. The purpose of BSE is to assess the impact of ethnic factors on a drug's safety and efficacy and to determine whether pharmaceutical sponsors should conduct regional bridging studies in Taiwan. In this report, we provide the background and experience of BSE implementation in Taiwan and its influence on the global drug development process. Our BSE review process, allowing bridging studies to be waived, has successfully prevented conducting clinical trials with meaningless results. The trend of Investigational New Drug Application submission after New Drug Application (post-NDA) in other countries has also been shifted to the pre-NDA stage. The implementation of BSE in new regions has encouraged the pharmaceutical industry to consider the impact of ethnic factors in the early phase of clinical studies.
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