title: Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis.
abstract: The registration process for new drugs is crucial in the clinical application of medicines. Previously, the registration of imported novel therapeutic agents in Taiwan depended considerably on their approvals in developed countries. The Taiwanese government enacted Article 38-1 of the Regulations for Registration of Medicinal Products in September 2009. According to the new submission criteria, approvals may be exempted if the number of Taiwanese participants in the clinical trials fulfills the required threshold. The present study compared the profiles of clinical trials of novel therapeutic agents before and after the enactment of this regulation in terms of over-threshold trials, structural types, and therapeutic areas across phases. The outcome-whether the liberalization of the submission criteria functioned as an incentive to launch clinical trials in Taiwan-was also evaluated. The results revealed that the number of clinical trial applications increased after the reformed regulation was enacted, even after the over-threshold criteria were considered; however, the increase disappeared for phase III trials. Most clinical trials were for chemical products and antineoplastic agents across all phases and study periods before and after the enactment of Article 38-1. Furthermore, the increase in the number of international clinical trials conducted in Taiwan was not directly caused by the regulation reform because the percentage of investigational products fulfilling the exemption criteria did not increase. These paradoxical results were interpreted in several aspects, referring particularly to the well-established infrastructure for launching clinical trials as well as the integral environment of medical services in Taiwan.
authors.affiliation: Division of Pharmaceutical Science, Center for Drug Evaluation, Taipei, Taiwan, Republic of China. icsun@cde.org.tw.|School of Pharmacy, National Defense Medical Center, Taipei, Taiwan, Republic of China. icsun@cde.org.tw.
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Sun
authors.affiliation: Division of Pharmaceutical Science, Center for Drug Evaluation, Taipei, Taiwan, Republic of China.
authors.forename: Horng-Shing
authors.initials: HS
authors.lastname: Shy
authors.affiliation: Division of Pharmaceutical Science, Center for Drug Evaluation, Taipei, Taiwan, Republic of China.
authors.forename: Tzu-Ya
authors.initials: TY
authors.lastname: Liao
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage; D017326:Clinical Trials, Phase III as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D006801:Humans; D007391:International Cooperation; D013624:Taiwan
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational
keywords: Clinical trial; Novel therapeutic agent; Phase I; Phase II; Phase III; Regulation reform; Submission criteria