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:

Regulatory Responsibilities

  • 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

Operational Responsibilities

  • Clinical Trial Supply importation and management
  • Contracting, site management and monitoring of the clinical trial as the Japanese sponsor
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