Japan’s Pharmaceutical Affairs Law requires companies without a Japanese subsidiary to designate a Clinical Trial In-Country Caretaker (CT-ICC) in order to file Clinical Trial Notifications (CTNs) and implement Japanese clinical trials.
Serving as a CT-ICC, IDA undertakes the following Japanese regulatory and operational obligations on behalf of foreign Sponsors:
- Preparation, filing and maintenance of Clinical Trials Notifications (CTNs)
- Manage all regulatory interactions with PMDA and MHLW on behalf of the Sponsor
- Assumption of all safety/ pharmacovigilance reporting responsibilities
- Clinical Trial Supply importation and management
- Contracting, site management and monitoring of the clinical trial as the Japanese sponsor