Abstract
New drug development is a regulation-intensive global activity. To protect and promote public health, in 1998 Taiwan set up the Center for Drug Evaluation (CDE) as a nonprofit, nongovernment organization to perform regulatory consultation, clinical trial protocol, new drug application, and health technology assessment delegated by the legal regulatory authority, the Bureau of Pharmaceutical Affairs (BPA). Over the last 10 years, this innovative experimental model of regulatory science in Asia has had many achievements to share with the international regulatory communities, such as bridging study evaluations, the Critical Path Project for index cases, and the proposed revival of the Pharmaceutical Evaluation Report scheme in APEC. CDE/BPA has now been recognized as one of a few regulatory agencies in Asia that can perform in-depth in-house review following the best international practice.
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References
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Chern, HD., Gau, CS., Chen, HM. et al. An Experimental Model of Regulatory Science in Asia: Center for Drug Evaluation in Taiwan. Ther Innov Regul Sci 43, 301–304 (2009). https://doi.org/10.1177/009286150904300308
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DOI: https://doi.org/10.1177/009286150904300308