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SHARE 링크연결 공유 인쇄

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

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

Reporting on cell
processing business

Safety management

of institution

  • Management of clinical studies record
  • Management of cell processing business record


  • 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

KOGL, Korea Open Government License, BY, NC, NDType 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".