Rules and systems
Japan's Act on the Safety of Regenerative Medicine, the PMD Act, review committees, provider plans, and medical advertising rules — the framework explained.
Roles of the two laws
The Act on the Safety of Regenerative Medicine sets review, notification, and delivery requirements for providing cell therapies through private practice or clinical research. The Pharmaceuticals and Medical Devices Act governs approval and post-marketing surveillance of regenerative medical products.
Which framework a treatment falls under changes which documents to check.
Provision plans and certified committees
Provision under the Safety Act involves review by a certified committee and submission of a provision plan to the Ministry of Health, Labour and Welfare. Providers can state the procedure names and numbers in their explanations.
Completing procedures signals a system is in place, but it does not guarantee safety.
Medical advertising rules
Advertising by medical institutions is regulated by the Medical Care Act and guidelines. Displays of unsubstantiated effects or exaggerated superiority are inappropriate. Check sources and wording carefully when reading ads.
Read ads separately from editorial articles. This site always labels ads as such.