Chapter 10 - Clinical Trials in Taiwan

Abstract

This chapter discusses clinical trials in Taiwan concerning demography, climate, statistics, research, challenges and opportunities. Taiwan's quick industrialization and rapid growth during the latter half of the twentieth century is called the “Taiwan miracle” or “Taiwan economic miracle”. The Center for Drug Evaluation (CDE) was established by the Department of Health of Taiwan on July 13, 1998. A functional Office of Evaluation was created by merging the reviewers from the Center for Drug Evaluation (CDE) and the TFDA. The TFDA is now leading an Asia Pacific Economic Cooperation (APEC) Best Regulatory Practice project under APEC's Life Science Innovation Forum. Taiwan's good clinical practice (GCP) guideline was officially announced in 1996 and was revised in 2002 according to the International Conference on Harmonization (ICH). China–Taiwan regulatory cooperation has been proposed for simultaneous clinical trial evaluation and new drug development. Many entrepreneurs like Quintiles, Covance, PPD, and ICON, have already queued up to set up their clinical research organizations in Taiwan. The Cross Strait Biotechnology and Medical Device Industry Partnership and Dialogue held in May 2010 in Taipei opened up dialogue on many issues related to the biopharmaceutical industry. Mutual benefit and collaboration can be achieved through continuous international cooperation and harmonization on regulation and review processes. The APEC LSIF Best Regulatory Practice Project from Taiwan is a high-priority two-year project recommended by APEC Life Sciences Innovation Forum Regulatory Harmonization Steering Committee (LSIF RHSC) to invite regulators from regional developing countries to work together.