10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

Please refer to Section 4.5.

10.2 Pediatric Investigation Plan

There is no PIP required in Japan.

10.3 Clinical Study (Interventional or Observational)

A Clinical Trial Notification is required for the following types of products:

1. Drugs with active ingredients differing from those of approved drugs.
2. Drugs with active ingredients that are the same but the route of administration is different from approved drugs.
3. Drugs differing from combination ratio of active ingredients, or indications or dosage and administration of approved drugs.
4. Drugs with active ingredients that are the same ingredient that had been approved as a new molecular entity but for which the re-examination period has not expired. 
5. Drugs expected to be biological products.
6. Drugs manufactured using recombinant technology.

A CTN is not required for an observational study where the product is administered within its approved conditions of use.