Regenerative medicine
- Market size
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- Regenerative medicine market size: JPY 9 billion (2012)
- Regenerative medicine surrounding industries market size: JPY 17 billion (2012)
- Market growth potential
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- Regenerative medicine market size: JPY 95 billion (2020 forecast)
- Regenerative medicine surrounding industries market size: JPY 95 billion (2020 forecast)
- Pharmaceutical Affairs Act was amended and came into effect in November 2014 as the Act to Ensure the Quality, Efficacy and Safety of Drugs and Medical Devices (aka Pharmaceutical and Medical Device Act), which newly defines products for regenerative medicine, separate from drugs and medical devices. A system for conditional and time-limited approval of such products for regenerative medicine has also been introduced to facilitate early commercialization while ensuring safety. Through this system, products can be approved within the quickest period of time in the world.
- Key points
- The range of "products for regenerative medicine" has been defined as:
- Products derived from cultured or processed human cells
1. to reconstruct, restore, or create human body structure and/or functions, or
2. for use with the aim of treating or preventing disease - Products for use in human cells for the purpose of genetic treatment.
- Products derived from cultured or processed human cells
- Because products for regenerative medicine use human cells, a feature of these products is, in reflection of individual differences, a lack of uniformity in quality. A special system was thus introduced for quick, conditional and time-limited approval of these products if efficacy can be assumed and safety confirmed. The efficacy and safety of such products approved under this system must again be verified, with a reapplication for approval filed in principle within seven years.
- To use such products, physicians and other relevant professionals must strive to provide appropriate explanation to the patients and receive their consent. As a post-marketing safety measure, with regard to products for regenerative medicine designated by the Minister of Health, Labour and Welfare, the business manufacturing and marketing the products must retain records for a long period of time, and medical institutions must record and keep information on the patients using the products.
- Products for regenerative medicine come under health insurance from the stage of conditional and time-limited approval.
- Advantages of setting up business in Tokyo
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- Tokyo is home to many research institutions that are studying regenerative medicine, including universities such as Keio University, Tokyo Women's Medical University, and Tokyo University, and the National Institute of Advanced Industrial Science and Technology. In order to partner up with or cooperate with such organizations, it will be very effective to establish a base in Tokyo.
- Many relevant companies such as the headquarters of pharmaceutical companies are also gathered in Tokyo. The Forum for Innovative Regenerative Medicine (FIRM), an industry group, has an office in Nihombashi, close to Tokyo station. FIRM has a consultation desk that serves mainly to provide overseas companies with information on how to use the Japanese legal system and to facilitate business matchups between overseas firms and FIRM member companies in Japan. Tokyo has a very good environment for companies searching for the perfect business partner.
METI"Regenerative Medicine System Building and Business Development" (2014)
Jiho Inc. "Pharmaceutical Affairs Pamphlet 2015")
Ministry of Health, Labour and Welfare website