Clinical Trials Notification
The MFDS Clinical Trials Notification (의료기기 임상시험 계획 승인 등에 관한 규정) provides detailed requirements for obtaining clinical trial approval and conducting trials under Korean GCP.
Key provisions
- Application requirements for clinical trial approval
- Minimum contents of a clinical trial protocol
- Informed consent requirements
- IRB submission requirements
- Safety reporting during trials (serious adverse events)
- Record-keeping and archiving (minimum retention periods)