An Overview of Bridging Study Evaluation in Taiwan
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I-Lin Ryan Lee, PLD Reviewer. Division of Preclinical Sciences, Center for Drug Evaluation. Taipei. Taiwan Chih-Lir Lln, MD, LLM Director. Division of Clinical Sciences. Center for Drug Evaluation, Taipei. Taiwan Mil-SLrng LIn, MD ChieJ Clinical Pharmacology Consultation Unit, Cathay General Hospital, Taipei, Taiwan
Key Words Bridging study; Ethnic factors; Bridging study evaluation (BSE) Correspondence Address Min-Shung Lin, 7F, No. 6 , Lane 2 6 6 , Sec. 4. Ren-ai Rd.. Taipei 106, Taiwan (ernail: [email protected]).
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An Overview of Bridging Study Evaluation in Taiwan
Li-Li Su, MS Reviewer. Division of Preclinical Sciences, Center for Drug Evaluation. Taipei. Taiwan Herag-Der Cham, MD, PhD Executive Director. Center for Drug Evaluation, Taipei, Taiwan
IN ASIA/PACIFIC: PART 2
In 2001, the Bridging Study Evaluation (SSE) review process based on the ICH ES guideline was introduced in Taiwan. f i e purpose of BSE is to assess the impact of ethnicfactors on a drug's s a f e and efficacy and to determine whether pharmaceutical sponsors should conduct regional bridging studies in Taiwan. In this report, we provide the background and expetience of BSE implementation in Taiwan and its influence on the global drug development process. Our
INTRODUCTION In order to harmonize the regulatory requirements of the drug development process based on good regulatory science, Japan, the United States, and members of the European Union have worked together to establish the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) since 1990. The ICH announced a guideline (ICH E5) that recommends a number of criteria for evaluating the impact of ethnic factors that may affect a drug's safety and efficacy in order to extrapolate clinical data between different regions in 1998. The ethnic factors, including intrinsic and extrinsic factors, should be taken into consideration during drug development as well as the approval process (1).In Taiwan, a local registration trial with a minimum of 40 subjects was requested for New Drug Application (NDA) when the "July 7 Announcement" was issued in 1993. In compliance with the principles of the ICH E5 guideline and in order to prevent conducting clinical trials with meaningless results, the Department of Health (DOH) revoked the July 7 Announcement and issued the "Double Twelve Announcement" on December 12, 2000. The Double Twelve Announcement introduced the concept of bridging study evaluation (BSE). The purpose of BSE is to assess whether the target
BSE review process, allowing bridging studies to be waived, has successfilly prevented conducting clinical trials with meaningless results. The trend of Investigational New Drug Application submission after New Drug Application (postNDA) in other countries has also been shifted to the pre-NDA stage. The implementation of BSE in new regions has encoumged the pharmaceutical industry to consider the impact of ethnicfactors in the early phase of clinical studies.
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