An Experimental Model of Regulatory Science in Asia: Center for Drug Evaluation in Taiwan
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Herng-Der Chrrn, MD, PhD Executive Director; Center for Drug Evaluation. Taipei. Taiwan Churn-Shiorh Gar, PhD Deputy Executive Director, Center for Drug Evaluation, Taipei. Taiwan
Hsr-Mei Hsr Chon, MSc Director. Department of Science, Department of Health, Executive Yuan. Taiwan Chi-Chor Liao, PhD Director General, Bureau of Pharmaceutical Affairs. Department of Health, Executive Yuan. Taipei, Taiwan
Key Words Center for Drug Evaluation; Regulatory science; Bureau of Pharmaceutical Affairs; FDA Correspondence Address Dr. Herng-Der Chern, MD, PhD, Center for Drug Evaluation. 1 F, No. 15-1 . Sec. I , Hangjou S . Rd.. Taipei 100,Taiwan (email: [email protected]).
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An Experimental Model of Regulatory Science in Asia: Center for Drug Evaluation in Taiwan 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 protocd, new drug application, and health techndogy assessment delegated by the legal regulatory authority, the Bureau of Pharmaceutical Aflairs (BPA). Over the last 10 years, this innovative experimental
A N IN N O V A T l V E EX PER IM E N TA L M O D E L OF REGULATORY AUTHORITY In 1997, Taiwan chose the biopharmaceutical industry as one of its national priorities for economic development. However, Taiwan had little experience of new drug development at that time. Most of the domestic pharmaceutical companies were manufacturers for generic products. The Strategic Review Board (SRB) was convened to review how to nurture the capacity of the biopharmaceutical industry in Taiwan. As the biopharmaceutical industry is a regulation-intensive industry involving human health, upgrading the capacity of the local regulatory agency up to the best international practice was recommended by many overseas experts. Though the aim was clear, it was soon realized that there were too many administrative restrictions on quickly recruiting needed professionals into the civil service system in terms of a competitive salary scale, credential tests, and administrative processes to increase head counts of the regulatory agency. Modeling a strategy that has worked quite well for Taiwan to develop an information technology industry, SRB recommended that Taiwan set up a nongovernment, nonprofit foundation, the Center for Drug Evaluation (CDE), to conduct regulatory consultation and evaluation of medicinal products with good regulatory science to sup-
model of regulatory science in Asia has had many achievements to share with the international regulatory communities, such as bridging stu& 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.
port the final decision of the legal authority, the Bureau
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