Submission of non-clinical trial data
The Korea Ministry of Food and Drug Safety (MFDS) has revised regulations regarding the approval of clinical trial plans for pharmaceuticals.
This notification will take effect from January 16, 2024.
- Allow the submission of non-animal or human biology-based test (cell-based assays, microphysiological systems, bioprinting, computer modeling, etc.) data for non-clinical trial data.
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