Conducting clinical trials in Taiwan -a case study under a new regulatory environment

摘要

The environment for performance clinical trials in Taiwan(China)has improved consider- able over the past two years. The major improvements including joint IRB operation, GCP implementation, ADR reporting system, and expedited drug approval process will be discussed in this presentation. A case study on phaseⅢ multi-center trial will also the be discussed to illustrate a new Taiwan experience.