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Dissemination of Regenerative Medicine - A comparison of the regulatory systems between Japan and Korea - (Japanese)


  • KURATA Kenji
  • Youn-Hee CHOI


Although Japan has surpassed Korea in terms of R&D activities in the area of regenerative medicine, Korea has been more successful in its commercialization. As one of the key reasons for this, the 'posture' of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is often criticized. Rather than dwelling on the abstract, this paper chooses to focus on the set up and operation of actual systems that take into consideration the promotion of regenerative medicine in Japan. Analysis and case studies of the regulatory systems in Japan and Korea show a clear difference between the two countries, although their systems are basically the same. There are two pathways for applying unapproved medicine in clinical research, including regenerative medicine, to human subjects in Japan, whereas there is only one pathway in Korea. The Korean Food & Drug Administration (KFDA) is the only authority through which approval can be gained in Korea. In comparison, Japan has one additional pathway besides approval through the PMDA if the clinical research is conducted within the framework of the Doctor's Affairs Law. We assume that the coexistence of the two pathways in Japan causes inefficiency in promoting the industrialization of regenerative medicine products. Therefore, it is advisable to combine the two pathways into one under PMDA authority, in order to disseminate regenerative medicine in Japan.

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  • KURATA Kenji & Youn-Hee CHOI, 2010. "Dissemination of Regenerative Medicine - A comparison of the regulatory systems between Japan and Korea - (Japanese)," Discussion Papers (Japanese) 10039, Research Institute of Economy, Trade and Industry (RIETI).
  • Handle: RePEc:eti:rdpsjp:10039

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    1. Andrei Shleifer & Florencio Lopez-de-Silanes & Rafael La Porta, 2008. "The Economic Consequences of Legal Origins," Journal of Economic Literature, American Economic Association, vol. 46(2), pages 285-332, June.
    2. Michel Aglietta & Antoine Rebérioux, 2005. "Corporate Governance Adrift," Books, Edward Elgar Publishing, number 3675.
    3. Nicholas Bloom & John Van Reenen, 2007. "Measuring and Explaining Management Practices Across Firms and Countries," The Quarterly Journal of Economics, Oxford University Press, vol. 122(4), pages 1351-1408.
    4. Julian FRANKS & Colin MAYER & MIYAJIMA Hideaki, 2009. "Equity Markets and Institutions: The case of Japan," Discussion papers 09039, Research Institute of Economy, Trade and Industry (RIETI).
    5. Hall, Peter A. & Gingerich, Daniel W., 2004. "Varieties of Capitalism and Institutional Complementarities in the Macroeconomy," MPIfG Discussion Paper 04/5, Max Planck Institute for the Study of Societies.
    6. Henry Hansmann & Reinier Kraakman, 2000. "The End Of History For Corporate Law," Yale School of Management Working Papers ysm136, Yale School of Management, revised 01 Feb 2001.
    7. Rafael La Porta & Florencio Lopez-de-Silanes & Andrei Shleifer & Robert W. Vishny, 1998. "Law and Finance," Journal of Political Economy, University of Chicago Press, vol. 106(6), pages 1113-1155, December.
    8. Streeck, Wolfgang & Thelen, Kathleen (ed.), 2005. "Beyond Continuity: Institutional Change in Advanced Political Economies," OUP Catalogue, Oxford University Press, number 9780199280469.
    9. Rajan, Raghuram G, 1992. " Insiders and Outsiders: The Choice between Informed and Arm's-Length Debt," Journal of Finance, American Finance Association, vol. 47(4), pages 1367-1400, September.
    10. Nicholas Bloom & Christos Genakos & Raffaella Sadun & John Van Reenen, 2011. "Management Practices Across Firms and Countries," CEP Discussion Papers dp1109, Centre for Economic Performance, LSE.
    11. Andrei Shleifer, 2009. "The Age of Milton Friedman," Journal of Economic Literature, American Economic Association, vol. 47(1), pages 123-135, March.
    12. Takeo Hoshi & Anil Kashyap & David Scharfstein, 1993. "The Choice Between Public and Private Debt: An Analysis of Post-Deregulation Corporate Financing in Japan," NBER Working Papers 4421, National Bureau of Economic Research, Inc.
    13. Masahiko Aoki & Gregory Jackson, 2008. "Understanding an emergent diversity of corporate governance and organizational architecture: an essentiality-based analysis -super-1," Industrial and Corporate Change, Oxford University Press, vol. 17(1), pages 1-27, February.
    14. Boyan Jovanovic & Peter L. Rousseau, 2002. "The Q-Theory of Mergers," American Economic Review, American Economic Association, vol. 92(2), pages 198-204, May.
    15. Park, Kwangwoo, 2002. "Foreign Ownership and Firm Value in Japan," CEI Working Paper Series 2002-15, Center for Economic Institutions, Institute of Economic Research, Hitotsubashi University.
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