The “Act on the Safety of Regenerative Medicine”, a legal framework for regenerative medicine, was implemented in November 2014. Regenerative medicine is ranked as a national growth strategy in Japan.
The “Pharmaceutical and Medical Device Act” regulates manufacture and cell of tissue-engineered medical products, and the “Act on the Safety of Regenerative Medicine” regulates private practices and clinical studies using such cells.
The Pharmaceutical and Medical Device Act newly defines “tissue-engineered medical products” and provides safety and other measures by taking their characteristics into consideration. Its goal is to grant marketing authorization.
Provisions of the Act on the Safety of Regenerative Medicine enable medical institutions to outsource cell processing to an external contractor. The regulations are expected to help facilitate the industrialization of cell processing.
The environment surrounding regenerative medicine has greatly changed as a result, and we now have an opportunity to make it a new growth industry.
We are looking forward to fostering a new era of regenerative medicine by fulfilling our mission: the widespread adaptation of regenerative medicine in order to establish its position and make it available for patients.
Regenerative medicine is a delicate medical, such as the 2014 birth of the newborn that has been legalized. We have the necessary part is technological development with a focus on still many universities. Much of the information related to research and development from the Ministry of Health, Labour and Welfare and the PMDA in it has been originated, but it does not say that the environment is sufficient condition for learning in the people of the researchers. Therefore, the practice training in the CPC of regenerative medicine Academia model service is our parent company Fuji Soft Co., Ltd., we have been supporting as a hands-on education by our technician.
President of FUJISOFT Tissue Engineering CO., Ltd.