Updates on IND Process and Clinical Trials Status in Taiwan
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Jon-Jib Liao, MD Team Leader. Division of Clinical Sciences. Center for Drug Evaluation. Taipei. Taiwan
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Updates on IND Process and Clinical Trials Status in Taiwan
Chi-Ckou Lioo, PhD Director General. Bureau of Pharmaceutical Aflairs. Department of Health. Executive Yuan, Taipei. Taiwan
Angela On, PCarmD Director. Division of Project Management, Center for Drug Evaluation. Taipei. Taiwan
Herng-Der Chern, MD, PhD Executive Director. Center for Drug Evaluation. Taipei, Taiwan
Mia-Shrng Lin, MD Chief, Department of Family Medicine. Cathay General Hospital. Taipei. Taiwan
In Taiwan, the Center for Drug Evaluation (CDE)plays an important d e in the Investigational New Drug (lND) review pmcess. This article describes the ovemll IND review mechanisms as wefl us the most current reform review process m Taiwan. me new system is aimed at impraving eficiencv, predictability, and tmnspareng for the IND review p’ocess and outcomes. The goal of the m f m is to enhance Taiwan’s regulatory environment and pmess to become one of the leading locations for clinical
Key Words IND; Clinical trial: Taiwan
Correrpondente Address Min-Shung Lin. MD. No. 280. Sec. 4 , 1en-A; Rd., Taipei, Taiwan (email: jab2 @cgh.org.tw).
INTRODUCTION The Center for Drug Evaluation (CDE) was established by the Department of Health (DOH) of Taiwan on July 13,1998,with the vision “Regulation, for Life.” CDE has since been playing a pivotal role in enhancing the efficiency and quality of medical products review and approval process delegated by DOH, thus promoting public health and welfare through timely access to innovative medicines (1). CDEs continuous efforts to improve initiatives and expand regulatory science consultation services to various sectors of industry, academia, and government reflect its evolving philosophies and approaches to the drug review process as well as its response to emerging issues such as subject and patient protection and public health promotion. Ten years after its establishment, today the center encompasses six divisions, including the Division of Clinical Sciences, the Division of Preclinical Sciences, the Division of Medical Devices, the Division of Health Technology Assessment, the Division of Project Management, and the Division of Resource Development (2). The most current review process for Investigational New Drug (IND) applications has been consolidated by CDE with the delegation by DOH since February 2007 when the major re-
trials among Asian countries. However, the drug
lag and optimal dose for the domestic population are still regarded as major issues in Taiwan and in neighboring Asian countries. To resobe these issues, it is recommended that Asian dinical studies be conducted using stmtegies and designs similar to those used in other parts of the world. Furthennm,the current status of ongoing dinical trials in Taiwan, bridgmg studies mpiments, and pharmacogenomic issues me also discussed in this article.
sponsibility of reviewing IND was transferred to CDE. IND review responsibility has shifted from a
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