Updates on IND Process and Clinical Trials Status in Taiwan

Abstract

In Taiwan, the Center for Drug Evaluation (CDE) plays an important role in the Investigational New Drug (IND) review process. This article describes the overall IND review mechanisms as well as the most current reform review process in Taiwan. The new system is aimed at improving efficiency, predictability, and transparency for the IND review process and outcomes. The goal of the reform is to enhance Taiwan’s regulatory environment and process to become one of the leading locations for clinical 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 resolve these issues, it is recommended that Asian clinical studies be conducted using strategies and designs similar to those used in other parts of the world. Furthermore, the current status of ongoing clinical trials in Taiwan, bridging studies requirements, and pharmacogenomic issues are also discussed in this article.