New governmental regulatory system for regenerative medicine in Japan

Abstract

The trend of regenerative medicine has been gaining a rising global attention and has been the target of growing research funds. This includes the importance of the application of cell-based therapy, especially stem cells, for various diseases. Hence, regulations on the use of cells and the pros and cons of its application in the clinical level should also be given equal attention. Recently, regulations in Japan have been reviewed and revised to create more effective and competitive marketing strategy. The Regenerative Medicine Promotion Law was established to provide prompt and safe regenerative medicine products. The Acts on the Safety of Regenerative Medicine entails that medical technologies can be categorized into 3 classes of regenerative medicines based on their risks potentials. It also determines the proper regulation or requirement for each class. Amendment of Pharmaceutical Affairs Act, on the other hand, is regulation in which products can be approved with temporary conditions to enable prompt provision of the products to patients after the safety and efficacy is confirmed. Due to these mitigations in Japan in the advancement of regenerative medicines, we can predict that Japan can be one of the top nations in the production and marketing stem cell therapeutic products by attracting Japanese as well as global companies. Hence, monitoring the changes in the legal policies of regenerative medicine in Japan could be advantageous in the advancement of the current provisions in South Korea geared towards the better achievements in providing the human population with safe, prompt, and effective regenerative medicine therapeutic strategies and products.