Evolution of Clinical Trial Requirements in Taiwan’s Pharmaceutical Registration

Abstract

After the implementation of good manufacturing practice in the early 1980s, Taiwan established a relatively effective regulatory process for pharmaceutical registration. The regulatory process for new drug applications (NDAs) in Taiwan, however, relied on foreign-derived documentation, especially the clinical data. The evolution of clinical trial requirements for product registration can be broken down into four phases over the past 15 years. It started with the initiation of postmarketing surveillance (PMS) in the early 1980s to restrict the entry of generic imitations and to provide adequate protection of pharmaceutical innovations. This was followed by a series of legislation or amendments on relevant legal requirements, such as the Patent Law, the Medical Care Act, the Bioavailability and Bioequivalence Guidelines, and the Pharmaceutical Affairs Law. The emerging pipeline protection in the early 1990s resulted in the 1993 Amendment of 1983 PMS that requires domestic clinical data for new drug applications.