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    10. Roadmap of the Submission Process of a Clinical Trial
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    10. Roadmap of the Submission Process of a Clinical Trial

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    10.1 Clinical Trial with Investigational Medicinal Product 

    1. Submit CTA to EC for approval.
    2. Upon approval, submit an application for Import Licence to the Thai FDA.

    10.2 Pediatric Investigation Plan (PIP)

    FDA does NOT require a PIP. Please refer to the information provided in Section 9.3 of this guidebook for guidance on the use of minors in clinical studies.

    10.3 Clinical Study (Interventional or Observational)

    Observational trials, for medication or medical devices, do not require approval.

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