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The Social Framework Surrounding the Development of Regenerative Medicine in Japan

  • EISUKE NAKAZAWA, YOSHIYUKI TAKIMOTO and AKIRA AKABAYASHI

Abstract:

In 2014, the Japanese government amended the laws concerning regenerative medicine. This reform aimed to contribute to the appropriate promotion of regenerative medicine and new drug discovery for intractable diseases using stem cells. It also helped restrict stem cell tourism, that is, provision of stem cell therapy of unclear efficacy and safety to tourists from abroad, and its relaxed regulations may even lead to the resolution of the drug lag problem. Stem cell medicine is positioned as a part of a national growth strategy that requires cooperation among the industry, government, healthcare field, and academia. It can be characterized as a “mesoscopic strategy,” in that it aims to achieve high-level technological developments that would allow results from human-induced pluripotent stem cell and traditional stem cell research to contribute to regenerative medicine and drug development for intractable diseases, while attempting to strike a balance with commercialization and improved access of citizens to cutting-edge medical care.

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Notes

1. For further information about the PMD Act and RM Act, see, Azuma, K. Regulatory landscape of regenerative medicine in Japan. Current Stem Cell Reports 2015;1:118–28. It is a comprehensive overview of the current regulatory situation in Japan. And see also, Sengoku S, Sakurai M, Yashiro Y. Japan’s regulatory framework: seeking to provide impetus to the commercialization of regenerative medicine products. Cell & Gene Therapy Insights 2015. DOI:10.18609.cgti.2015.008.

2. Shinsou, Saisei iryo:/ 1 Rainichi kankokujin ni kansaibou “Tojou chiryou no rakutenchi” [In-depth look on regenerative medicine:/ 1 Stem cells given to South Koreans visiting Japan. “Carefree site for en route medical care”]. Mainichi Shimbun 2012 Dec 22.

3. Unknown territory. Nature 2013;494(7435):5.

4. For further information about the case, see, Ikka, T, Fujita, M, Yashiro, Y, Ikegaya, H. Recent Court Ruling in Japan Exemplifies Another Layer of Regulation for Regenerative Therapy. Cell Stem Cell 2015;17(5):507–8.

5. Saisei iryou meguri ishi ni baishou meirei: Tokyo chisai “Setsumei fujuubun” [Court order for compensation issued to physicians involved in regenerative medicine: Tokyo Regional Court deems “insufficient explanation”]. Asahi Shimbun Apital 2015 May 16; available at http://apital.asahi.com/article/news/2015051600012.html (last accessed 16 Sept 2015).

6. Unknown territory. Nature 2013;494(7435):5.

7. This is the organization in charge of regenerative medicinal products and biological applications within the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labor and Welfare.

8. JCR pharma. News: Hito kanyoukei kansaibou (Kaihatsu bangou: JR-031), Kousei roudoushou yakushokushin no bukai de, saisei iryou tou seihin toshite hajimete shounin o ryoushou [News: Approval confirmed for the first time ever for human mesenchymal stem cells (JR-031) as regenerative medicinal product by the Food and Drug Safety review panel of the Ministry of Health, Labour and Welfare]; 2015; available at http://www.jcrpharm.co.jp/news/20150903_3976 (last accessed 16 Sept 2015).

9. Terumo. Newsroom 2015: Terumo’s autologous skeletal myoblast sheets are the first to be approved as a cellular or tissue-based products in japan by a council of the Ministry of Health, Labour and Welfare; 2015 Sept 2; available at http://www.terumo.com/about/pressrelease/2015/20150902.html (last accessed 16 Sept 2015).

10. For further information about commercial use of regenerative medicine products, see note 1, Sengoku et al. 2015.

11. Fujifilm. Health: Accelerate the development of regenerative medicine, backed by enforcement of the Act on the Safety of Regenerative Medicine; available at http://www.fujifilmholdings.com/en/sustainability/valuePlan2016/process/policy01/health2015/02.html (last accessed 16 Sept 2015).

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The Social Framework Surrounding the Development of Regenerative Medicine in Japan

  • EISUKE NAKAZAWA, YOSHIYUKI TAKIMOTO and AKIRA AKABAYASHI

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