The Current Status of Clinical Trials and GCP in Taiwan

Abstract

Clinical trials in Taiwan entered a new era when the Taiwan Department of Health made a public announcement that new drug applications would require submission of local clinical trial results with other preclinical and clinical documentation on July 7, 1993. Five years later, the type of clinical trials conducted in Taiwan has changed a lot. In the early years, most of the clinical trials were categorized as Phase TV studies (ie, registration trials) and the study designs lacked a statistical basis. Since 1997, more and more early phase (Phase I or II), multinational, multicenter clinical trials have been launched in Taiwan. This shows that clinical trials in Taiwan have become a new industry and the average quality and quantity has increased dramatically. In the future, the goal is to have the clinical trial related guidelines and regulations in Taiwan comply with International Conference on Harmonization standards.