10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

10.2 Pediatric Investigation Plan (PIP)

There is no requirement for a Pediatric Investigation Plan in South Korea. Plans for the investigation of a product in the pediatric population should be discussed with MFDS during the course of any scientific advice meetings.

10.3 Clinical Study (Interventional or Observational)

A clinical trial approval is only required where a product is not registered for marketing in Korea, or where the product is being used outside of the approved conditions of use.