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Supporting the Designation of Regenerative Medicine Institutions

Medical institutions are designated as an institution for regenerative medicine to perform clinical research on
regenerative medicine in accordance with Article 10 of the Act on Advanced Regenerative Medicine.
RMAF supports the overall process including preparatory resources, on-site due diligence, education and consulting
to ensure the efficient and smooth progression of the designation procedures.

Relevant grounds

  • 「첨단재생의료 및 첨단바이오의약품안전 및 지원에 관한 법률 」제10조(첨단재생의료실시기관)
  • 「첨단재생의료 안전 및 지원에 관한 규칙」제3조(첨단재생의료실시기관의 지정 및 운영)
Support Medical institutions

Support
Medical institutions

Education & Consulting documents for applying for designation

Criteria for designation (Facilities, equipment, personnel, standard operating instructions)

Filing documents to apply for designation

FAQ for medical institutions

Ministry of Health and Welfare Support

Support the Ministry of
Health and Welfare

Review the application documents and designation criteria - Requst supplements

Support on-site inspection

Expert consultation

Perform Appointed supporting Activities

Perform Appointed
supporting Activities

Provide support on the establishment and amendment of the law concerning the designation of institutions

Conduct case studies clinical research and test institutions in Korea and overseas

Administrative support in the designation process, etc

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