Companion Diagnostics
A companion diagnostic (동반진단기기) is an IVD essential for the safe and effective use of a specific therapeutic. Classified at Grade C or D under the IVD Act.
Regulatory coordination
- Companion diagnostic and associated drug must be approved together or reference the approved drug
- MFDS pharmaceutical division confirms clinical claims align with drug's approved indications
- Review timelines aligned with the drug approval
Technical requirements
- Full analytical and clinical performance evaluation
- Studies demonstrating patient response aligns with test result
- Co-validation with the drug/biological in the same patient population
Labelling
Must clearly state: the linked therapeutic product name; the patient population; the clinical decision based on the test.
Approval scenarios and timelines
Two approval pathways exist:
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Concurrent submission: Companion diagnostic and drug submitted together; review timelines are aligned and coordinated between pharmaceutical and medical devices divisions.
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Sequential submission: If the drug is already approved, the companion diagnostic may reference the approved drug indication and labelling. Review timeline is typically 3–6 months (Grade C) or 6–12 months (Grade D), aligned with standard 品목허가 timelines.
In both cases, MFDS pharmaceutical division must confirm that the companion diagnostic's clinical claims and patient population match the drug's approved indication.