Table 2.

The Challenge Application (CA) Form and Requirements in Japan ⁽⁴³⁾.

Form	Requirements
(Form 3-4) Eligibility of Challenge Application	• Manufacturers must submit this form to request eligibility for the Challenge Application program while they submit the dossier at an initial reimbursement application
	• Contents:
	-Eligibility of Challenge Application
	-Data collection and evaluation plan
(Form 15) Periodic report on Challenge Application	• Manufacturers must submit this form to the expert panel at a minimum of 2 years periodically
	• Contents:
	-Functions that manufacturers want to apply for Challenge Application, etc.
	-Status of data collection
(Form 16) Request for withdrawal	• If there is a legitimate reason, such as difficulty in collecting data, manufacturers can request withdrawal of eligibility of their Challenge Application
	• Once withdrawal is accepted, periodic reporting is unnecessary
	• Contents:
	-Reason for withdrawal and current status of data collection