Global Regulatory Pulse

Regenerative Medicine-Related Organizations and Activities in Japan

In Asian Market, Consulting, Regulatory by Akira Toyama

With the implementation of Japan’s Pharmaceutical and Medical Devices Law (PMDL), a number of important changes were introduced. Some of the major changes include strengthened safety measures, revision of medical device regulations based on their characteristics, and introduction of cellular and tissue therapeutic products. Understanding these changes are important for companies seeking approval of their medical device and cell therapy/regenerative medicine products in Japan. In this article, organizations which are of interest to companies intending to conduct business in Japan are introduced.

FIRM and JETRO

Because of the emphasis on promotion and development of regenerative medicine at the national level, The Forum for Innovative Regenerative Medicine (FIRM) was established in 2011 to facilitate development of regenerative medicine related R&D, business development, and commercialization of induced pluripotent stem (iPS), embryonic stem (ES), and adult/tissue stem cell-based products. Considerable efforts have been generated in Japan to promote development of these cell-based therapeutics in order to make Japan a world leader in this field. FIRM has similar function to The Alliance for Regenerative Medicine (ARM), and the two organizations signed a cooperative relationship agreement in 2015 in order to facilitate information exchange and overall development of regenerative medicine and therapeutics. FIRM maintains a close relationship with Japan External Trade Organization (JETRO). JETRO provides information and support to foreign companies looking for successful entry and expansion in the Japanese market. JETRO provides a wide range of services, including timely market intelligence, extensive business development support, and relevant business events which are designed to encourage new business between foreign companies and Japan. JETRO also provides current information on laws and regulations pertaining to establishing new business operations in Japan to assist companies in expanding their business to Japan. In addition, JETRO offers subsidy for foreign companies which are trying to establish business in Japan.

Tonomachi International Strategic Zone

Tonomachi, an industrial area near Tokyo, is rapidly emerging as an area with a high concentration of technological companies and research and development centers which engage in medical device and regenerative medicine products. In addition to its technological and scientific advantages, this area is important for medical device companies overseas because it is strategically located right next to Haneda Airport in Tokyo. Its proximity to the airport allows prompt distribution of products to Japan’s medical device market which is the second largest in the world. Furthermore, the high concentration of R&D centers provides business opportunities and has a synergistic affect in this collaborative environment. Tonomachi offers corporate tax reduction, subsidies from multiple ministries including Special Promotion Zone Adjustment Expenses, and interest subsidies for funds borrowed for establishment of businesses at the site.

Authors:

Akira Toyama received an M.S. degree in Microbiology from Eastern Washington University. He received a Ph.D. in Molecular and Cellular Biology from University of Southern California, and completed an NIH postdoctoral fellowship in the field of Cardiology and Regenerative Medicine at University of Minnesota Lillehei Heart Institute. Since 2015, he has been at NAMSA and currently works as a Medical Research Manager with primary focus on clinical and consulting work in Japan’s medical device industry.