Regenerative Medicine Development In Japan: Challenges And Key Success Factors For Rapid Approval

The global regenerative medicine market was valued at USD 23.8 Billion in 2018 and is projected to reach USD 152 billion by 2026. The market anticipates to expand remarkably due to advancement in technology in this field and growing applications in the treatment of chronic and incurable diseases. Asia-Pacific generated USD 6 Billion in 2018 and is predicted to be the fastest growing region for regenerative medicine.

In Japan, two laws regulating regenerative medicine became effective in 2014: The Act on the Safety of Regenerative Medicine (Safety Act) and The Act on Pharmaceuticals and Medical Devices (PMD Act). The PMD Act established an expedited conditional approval system for regenerative medicine that led Japan to be the world’s fastest approval.

As the first and largest CRO in Japan, CMIC Group’s three experts from regulatory consulting, non-clinical, and clinical research, will share current challenges and provide you with key factors for success.

• Regulatory framework in Japan and its challenges
• CMIC’s approach in the non-clinical area (regulation, guidance/guideline for non-clinical studies, case studies)
• Clinical trial: tips for success (current status and key points for regenerative medecine clinical trials in Japan)