Research & Development
Service
- UPDATE
- 2022-06-09
- Advanced regenerative medical safety management
Safety Management Institution for Advanced Regenerative Medicine
In accordance with Article 19 of the Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products, the Korea National Institute of Health was designated as a "Safety Management Institution" in order to ensure the safety of advanced regenerative medicine.
Key roles
- Supervise of institutions for regenerative medicine
- Receive adverse event reports of clincal research on regenerative medicine
- Operate data and safety monitoring board(DSMB)
- Receive annual reports of institutions for cell processing
Advanced Regenerative Medicine Information system(ARMI)
An information system for collection and management of advanced regenerative medicine clinical studies data
Advanced Regenerative Medicine Information system
Regenerative
medical institutions
Management of clinical studies
- Studies project setting
- eCRF design
- Management of human subject
- eCRF data entry
Reporting on adverse event
Reporting on institutions’
current status
Checking of statistics by project
Cell processing
facilities
Reporting on cell
processing business
Safety management
institution
Management
of institution
- Management of clinical studies record
- Management of cell processing business record
Safety
monitoring
- Management of adverse event occurrence
- Checking safety information
Management of
adverse event
- Real-time receipt of adverse event reports
- Management of adverse event investigation results
Management of long-term
follow-up study
- Management of long-term follow-up study status
- Management of long-term follow-up study subject
Operation of the advisory group for the safety management of advanced regenerative medicine
Review and advise on what is necessary for the safety management of advanced regenerative medicine
Type 4 : Source Indication - Commercial Use Prohibition - Change Prohibition The works of the Ministry of Science and ICT can be used under the terms of "KOGL Type 4".