Japan has one of the strictest regulatory systems for regenerative medicine in the world. Treatments using stem cells are governed by the Act on the Safety of Regenerative Medicine, which ensures that clinics meet high standards for safety, ethics, and quality control.

Under this law, medical institutions must submit treatment plans to government authorities and receive approval before providing regenerative therapies. Cell processing facilities must also be certified, guaranteeing proper handling and contamination prevention.

This regulatory structure protects patients by reducing risks and ensuring transparency. Clinics are regularly inspected, and medical professionals are held accountable for maintaining high standards of practice.

For international patients, Japan’s legal framework offers strong reassurance. It demonstrates that regenerative medicine is not provided casually but under careful national supervision.