Critical path initiative for regenerative medicine in japan

研究成果: Chapter

抜粋

The Act for the Comprehensive Acceleration of Policies Promptly to Give the People Regenerative Medicine Free from Danger (Act for the Promotion of Regenerative Medicine) was enacted in April and enforced in May 2013, and the enforcement of the Act led to the Act Concerning Safety Assurance of Regenerative Medicine (Act on the Safety of Regenerative Medicine) and the Revised Pharmaceutical Affairs Law (Pharmaceuticals and Medical Devices Law) (enacted in November 2013 and enforced on November 25, 2014). The old Pharmaceutical Affairs Law had only two categories, pharmaceuticals and medical devices, and therefore was an obstacle to the development of regenerative medicinal products under pharmaceutical regulations. It was a great trouble for us in academe, and we had to treat patients in uneasy darkness without the landmarks and lights of regulations. The solutions for the problem are an upgrade to the Guidelines for Clinical Research Using Human Stem Cells to the Act on the Safety of Regenerative Medicine and the introduction of a new category, cellular- and tissue-based products, under the Revised Pharmaceutical Affairs Law or Pharmaceuticals and Medical Devices Law. We have obtained two paths for generalization of regenerative medicine in our society. Among the so-called advanced nations, only Japan has these two paths, and the whole world is watching carefully the start of the grand social experiment for the release of regenerative medicine into society. The selected path would be the answer from the general public to the question of how to establish regenerative medicine in society.

元の言語English
ホスト出版物のタイトルGene Therapy and Cell Therapy Through the Liver
ホスト出版物のサブタイトルCurrent Aspects and Future Prospects
出版者Springer Japan
ページ139-146
ページ数8
ISBN(電子版)9784431556664
ISBN(印刷物)9784431556657
DOI
出版物ステータスPublished - 01-01-2016
外部発表Yes

All Science Journal Classification (ASJC) codes

  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)

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  • これを引用

    Okura, H., & Matsuyama, A. (2016). Critical path initiative for regenerative medicine in japan. : Gene Therapy and Cell Therapy Through the Liver: Current Aspects and Future Prospects (pp. 139-146). Springer Japan. https://doi.org/10.1007/978-4-431-55666-4_12