Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis

Investigational New Drugs
I-Chen SunTzu-Ya Liao

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 a...Continue Reading

References

Sep 5, 2013·JAMA : the Journal of the American Medical Association·Stephen MacMahonAnushka Patel
Sep 28, 2013·Contemporary Clinical Trials·Romi Singh, Ouhong Wang
Oct 22, 2013·PLoS Medicine·Corrado Barbui, Irene Bighelli
Jan 23, 2014·JAMA : the Journal of the American Medical Association·Nicholas S DowningJoseph S Ross
May 7, 2014·The American Journal of Gastroenterology·Arthur A CiociolaUNKNOWN FDA-Related Matters Committee of the American College of Gastroenterology
Dec 1, 2010·London Journal of Primary Care·Tai-Yin WuKen N Kuo
May 24, 2015·Computer Methods and Programs in Biomedicine·Yu-Chuan Jack LiMin-Huei Hsu

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Citations

May 31, 2016·Regulatory Toxicology and Pharmacology : RTP·I-Chen Sun

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