(1) Reasons for Proposal

To ensure safety under Articles 10 (4) and 19 (4) of the Act on the Safety of and Support for High-Tech Regenerative Medicine and High-Tech Biomedicines and Articles 5 (2) and 14 (4) of the Enforcement Rule thereof, this Regulation aims to define specific matters required to perform work delegated to the head of the Korea National Institute of Health.

(2) Major Provisions

A. Matters regarding the management and supervision of regenerative medicine sites (Articles 2 and 3)

B. Safety monitoring (Article 4)

C. Investigation into the cause of adverse events (Article 5)

D. Long-term follow-up (Articles 6 through 9)

E. High-Tech Regenerative Medicine Safety Advisory Group (Articles 10 through 13)