The Drug Regulatory Process of the Republic of China — Taiwan's Experiences in Bioavailability and Bioequivalence

The drug regulatory process and development of the pharmaceutical industry of the Republic of China in Taiwan has dramatically changed during the last 14 years. Consequently, the pharmaceutical industry, including not only the international giants in Taiwan but the local pharmaceutical manufacturers, has greatly improved both in its research and development as well as in the quality of its products. This report briefly examines the advancement of pharmaceutical affairs in Taiwan. The purpose of this paper is to provide an overview of Taiwan's experiences in the implementation of bioavailability and bioequivalence (BA/BE) which include issues of new regulations, guidelines, concepts, decision rules, and statistical methodology. It also reports the outcomes since the implementation of Taiwanese BA/BE guidelines in November 1987 through September 1994. There were 189 BA/BE reports submitted for review within this period. One hundred and two were performed in Taiwan and 87 were performed in other countries. The approval rates were 64.7% and 40.2%, respectively. The most frequent reasons that BA/BE studies were rejected by the Department of Health was that the AUC_∞ and/or C_max did not meet the acceptable criteria. The combination of efforts from academia, government officers, and scientists from the industry was the key to the successful implementation of new and significant improvements in the drug approval system in Taiwan.