Japan’s regulatory framework for regenerative medicine is designed to balance innovation with patient safety. The Act on the Safety of Regenerative Medicine classifies treatments into risk categories and applies different levels of oversight accordingly.

Higher-risk therapies require stricter review and monitoring, while lower-risk treatments are managed under simplified procedures. This flexible system allows medical progress while maintaining strong safety control.

All regenerative treatments must follow approved protocols, and clinics are required to report outcomes and safety data. This ensures accountability and continuous quality improvement.

For patients, this framework guarantees that regenerative medicine in Japan is practiced responsibly and transparently.