2025/06/24

Reports

【Overview】

　A joint seminar was held by the Japanese Society for Regenerative Medicine (JSRM), Health~Holland, and CReM TONOHANE at the Life Innovation Center (LIC) on June 24th, 2025.

　The Japanese Society for Regenerative Medicine (JSRM) also published the event report on the website. Click here for more information.

---

【Seminar Programme】

　The seminar began with opening remarks from Prof. Shigeto Shimmura, Director of Fujita Health University Haneda Clinic and Professor at Fujita Health University.

---

　In the first half of the seminar, Prof. Kohji Nishida, President of the Japanese Society for Regenerative Medicine and Professor at Osaka University, introduced “The 2012 YOKOHAMA Declaration (JPN version)”, as well as the overview of the  current legal and regulatory landscape for regenerative medicine in Japan.

　Subsequent presentations were given by Dr. Hideyuki Hakui of the Ministry of Health, Labour and Welfare (MHLW), and Dr. Yoshiaki Maruyama of the Pharmaceuticals and Medical Devices Agency (PMDA), who shared insights on the 10-year history of the Act on the Safety of Regenerative Medicine (ASRM) and the Act on Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (PMD Act), respectively.

---

　In the latter half of the seminar, Prof. Ton Rabelink from Leiden University Medical Center delivered a lecture on updates on the European regulatory framework for regenerative medicine, and their implementation in product development processes.

　Dr. Yosuke Ozawa, CEO of Epistra Inc., presented on the use of AI to streamline manufacturing processes and reduce production costs. Ms. Jun Takiyama of the Japanese Society for Regenerative Medicine introduced the “YOKOHAMA Declaration 2025 (ENG version)”, announced in March 2025.

　The session concluded with a presentation by Dr. Bernard Mulder, General Director of RegMed XB, who discussed initiates to improve patient access to advanced medical technologies in Europe and to strengthen academia-industry-government collaboration.

---

　During the Q&A session, a wide-ranging discussion occurred, covering topics such as regulatory frameworks for regenerative medicine in both the Netherlands and Japan, the development of technological infrastructure, and the application of AI and emerging technologies.

---

【Highlights of the seminar】

 

 

 

 

 

 

 

 

 

 

 

---

 

 

 

 

 

 

 

 

 

 

 

---