chapter  10
10 Pages


WithLi-Heng Pao, Jo-Feng Chi, Oliver Yoa-Pu Hu

INTRODUCTION The Bureau of Pharmaceutical Affairs (BPA) within the Department of Health (DOH) is responsible for the regulation of medicinal products in Taiwan. The mission of the BPA is to ensure that medicinal products that are available for the people in Taiwan are of the highest quality, safety, and efficacy. On the basis of BPA statistics, there are over 27,000 active licensed drugs currently available in the Taiwan market (1). Approximately 20% of Taiwan’s drug products are imported from abroad, the remainder being manufactured by domestic pharmaceutical companies that operate in compliance with current good manufacturing practice (cGMP) standards. Therefore, the need to ensure bioequivalence of generic drug products with corresponding innovator products is critical in Taiwan. The goal of this chapter was to provide an overview of the generic drug review process and bioequivalence requirements in Taiwan.