Critical Path Initiative for Regenerative Medicine in Japan

Abstract

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.