(1) Reasons for Proposal
In accordance with the enactment of the Act on the Safety and Support of High-Tech Regenerative Medical Service and Advanced Biopharmaceuticals (Act No. 16556, promulgated on Aug. 27, 2019, to enter into force on Aug. 28, 2020), this proposal aims to prescribe matters delegated to lower statutes in the Act and matters necessary for its enforcement.
(2) Major Provisions
A. Prescribe criteria regarding facilities, equipment, and personnel for designation as a high-tech regenerative medical service institution, and prescribe the scope of data to be submitted for application to be designated as such (Article 3)
B. Prescribe matters to be complied with by high-tech regenerative medical service institutions when using body cells, etc., in clinical research, and prescribe the scope of clinical research records to be registered in clinical research information systems (Articles 4 and 5)
C. Prescribe matters regarding the submission of detailed plans on clinical research and deliberation procedure of the secretariat on such submissions, and prescribe matters necessary in application for and approval of changes to research plans (Articles 9 and 10)
D. Prescribe major work procedure to be complied with by heads of cell processing facilities such as the storage of body cells, etc., and designation of persons in charge of records, etc. (Article 14)
E. Have the Korea Centers for Disease Control and Prevention serve as a high-tech regenerative medical services safety control institution, and prescribe procedures for conducting fact-finding surveys and collecting, reporting, managing, etc., related information (Articles 15 through 16)
F. Prescribe that high-tech regenerative medical service institutions shall have an obligation to report adverse reactions, and prescribe the scope and procedure of investigations conducted to find out the background and causes of adverse reactions (Articles 18 and 19)
G. Prescribe procedures necessary when ordering fact-finding surveys on high-tech regenerative medical service institutions using hazardous body cells, etc., and suspension of research, etc. (Article 21)
