Essential Considerations for ICCC

Essential Considerations for Requesting a Clinical Trial In-Country Representative
＜For Foreign Sponsor＞

As globalization of drug development progresses, foreign companies are increasingly planning clinical trials in Japan. There is a regulatory system for these companies (hereinafter referred to as foreign sponsors) to promote drug development in Japan through outsourcing the operations of clinical trials to Contract Research Organizations (CROs). The following is described in the Ministerial Ordinance on Good Clinical Practice for Drugs (hereinafter referred to as J-GCP: Attachment 1-1).

(Clinical Trial In-Country Representative)
In order to take the necessary measures to prevent the occurrence or spread of health hazards due to drugs used in the clinical trial, a person who intends to sponsor a clinical trial and resides outside Japan shall appoint a person eligible for sponsoring the clinical trial on behalf of the person who intends to sponsor a clinical trial from among persons residing in Japan (including the head of a Japanese business office of a foreign company) to have him or her (hereinafter referred to as “Clinical Trial In-Country Representative*”) conduct the procedures for sponsoring the clinical trial (J-GCP Article 15).
*: Clinical Trial In-Country Representative is referred to as an In-country Clinical Caretaker (ICCC) in this document.

This document is designed to outline the key considerations for foreign sponsors when outsourcing the responsibilities of the ICCC to a CRO. It highlights points to be noted and differences between overseas and Japanese systems, as well as Japan-specific regulatory requirements. It is intended to serve as a useful reference when conducting clinical trials in Japan.
Additionally, this document focuses on clinical trials for drugs with new active ingredients. It is also applicable to clinical trials for medical devices or regenerative medicine products, but since some rules are different, it is advisable to consult with the company that entrusts the ICCC when dealing with such products.