(1) Reasons for Proposal

To ensure safety under Article 10 paragraph 4 and Article 19 paragraph 4 of the Act on the Safety of and Support for High-Tech Regenerative Medicine and High-Tech Biomedicines and Article 5 paragraph 2, Article 13, and Article 14 paragraph 4 of the Rule on the Safety of and Support for High-Tech Regenerative Medicine and High-Tech Biomedicines, 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 3 and 4)

B. Safety monitoring (Article 5)

C. Adverse event reporting and investigation into the cause of adverse events (Articles 6 and 7)

D. Long-term follow up (Articles 8 and 9)

E. High-Tech Regenerative Medicine Safety Advisory Group (Articles 10 through 14)