KOR/837
WTO/TBT
KR Südkorea
  • 11 - Medizintechnik
2019-08-12
2019-06-14

Cell therapy and Gene therapy, Biopharmaceutics

Proposed Revision of the "Regulation on Approval and Review of Biological Products" (27 page(s), in Korean)

The main proposed amendments is as the following: - For the Biopharmaceutical's safety, Cell Therapy and Gene Therapy Product's manufacturer using the cell banking system should submit the cell consistency data (Short tandem repeat, etc) when establishing and running the cell banking for the approval.