Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences

Abstract

In the past 10 years since the implementation of the E5 guideline, bridging studies have been one of the most controversial ICH concepts for East Asian states. This article reveals the dynamics of bridging studies by comprehensively reviewing their evolution and policy impacts in Japan and Taiwan from a comparative perspective.

This article addresses the following. First, the concept of bridging studies has proved to be a diplomatic resolution rather than a scientific consensus. Although it facilitated the making of the E5 guideline, it left the problem of putting it into practice. Second, Japan did not wholeheartedly welcome bridging studies; it believed that a transition to spontaneous global trials would soon follow and exhausted its regulatory means to pursue it. Third, Taiwan captured this controversial concept as an ICH outsider, and showed the ICH the feasibility of bridging studies. It further attempted to extend their feasibility to create a multistate trial scheme, thereby keeping its visibility to the ICH.

In addition, based on these findings, this article provides a regulatory outlook on pan-Asian clinical trial schemes.

Keywords

ICH E5 guideline Bridging study Global drug development

Get full access to this article

View all access options for this article.

References

Anderson

Cone

Walker

Bridging studies in Asia and the impact of the ICH E5 guideline. Drug Inf J. 2003;37(November):107S-116S.

Denker

Sources of potential ethnic differences in pharmacokinetics. Drug Inf J. 2003;37(November):99S-106S.

Kuo

. Understanding race at the frontier of pharmaceutical regulation: an analysis of the racial difference debate at the ICH. J Law Med Ethics. 2008;36(3):498–505.

Question 26 and its answer in the Ministry of Health, Labor, and Wealth's guidance on the E5 guideline. In Yakugyoziho , ed. Kawarusinyakukaihatu no kokusaisenryaku: ICH E5 gaidorain no inpakuto [Changing global strategies for new drug development: the impact of the ICH E5 guideline]. Tokyo: Yakugyozihosha.

Mori

Recent situation of clinical trial consultation in Japan—especially consultation about bridging study. Presentation at the 2001 APEC Meeting for Pharmaceutical Regulatory Network. Taipei, Taiwan, May 25–26.

Uyama

Shibata

Nagai

Hanaoka

Toyoshima

Mori

Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther. 2005;78(2):102–113.

Chen

. ICH in Taiwan. Drug Inf J. 1998;32(October):1301S-1307S.

Lin

The origin of Minnan and Hakka, the so-called “Taiwanese,” inferred by HLA study. Tissue Antigen. 2001;57(February):192–199.

Center for Drug Evaluation. Available at: http://www.cde.org.tw/bse_website/index.html. Accessed September 27. 2008.

10.

Lin

Chern

Chu

Taiwan's experience with the assessment of the acceptability of the extrapolation of foreign clinical data for registration purposes. Drug Inf J. 2003;37(November):143–145.

11.

International Conference on Harmonization. E5 R1 ethnic factors in the acceptibility of foreign clinical data: questions and answers. Available at: http://www.ich.org/cache/compo/475–272-1.html#E5. Accessed November 14, 2008.

12.

Jao

Chern

Chu

. Reinventing drug regulation in the Asia Pacific region: Taiwan's experience and a vision for the region. Drug Inf J. 2003;37(November):41S-48S.

13.

Proceedings of 2003 Symposium on Statistical Methodology for Evaluation of Bridging Evidence. Nankang, Taiwan, November 15, 2003.

14.

Presentations at the 43rd DIA annual meeting, including Japan regulatory environment: overview of the organization, processes, systems, and changes affecting pharmaceutical development (Tutorial #53); PMDA challenges for global drug development including Japan (Session 281); outlook for changes in Japanese regulatory and clinical development environment (Session 387); and drug development in Japan: drug development models to ensure acceptance of preclinical data requirements as part of global drug development (Session 419). 2007.