Biological Products; Other (HS 300190); Other (HS 300490)

Enforcement decree of the Act on advanced regenerative medicine and advanced biological products regarding safety and support (71 page(s), in Korean)

- As the "Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products" is established, "Enforcement Decree of the Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products" is enacted to prescribe the matters delegated by the Act and those necessary for its implementation.

- Article 31: to prescribe facility standards required for the notification of importing business of advanced biological products.

- Article 32: to prescribe  facilities, equipment, human resources, and quality management system required for the approval of human cell management business, etc. - Article 34-36: 1) to stipulate that long-term follow-up investigations may be conducted on certain advanced biological products containing stem cell treatments, animal tissue and cells, gene therapy products and other advanced biological products that need to be monitored for adverse events over a specific period after administration. 2) to prescribe matters related to the designation as a subject of such investigations, the withdrawal of the designation, etc.