In-country Caretaker Service for Clinical Trial
In-Country Caretaker for Clinical Trial in Japan
Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) requires foreign Sponsors who conduct clinical trials in Japan to appoint the In-Country Caretaker (ICC) in Japan.
The ICC is a legal representative designated by the foreign Sponsor of a clinical trial in Japan as defined in Article 15 of Japan Good Clinical Practices (GCP)Regulation (MHLW Ministry Ordinance 36) and the ICC’s responsibilities are set forth Japanese GCP Guidance.
The roles and responsibilities of In-Country Caretaker
To conduct a clinical trial in Japan, the Clinical Trial Notification (CTN) must be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) to include a protocol and Investigator’s Brochure (IB). The CTN must be in Japanese and the ICC needs to submit it on behalf of the foreign Sponsor.
The Sponsor needs to conduct a Clinical Trial Protocol Consultation with PMDA with objective to receive PMDA approval for study, including to investigate the presented indications for use, sample size, validity of end point, and validity of statistical analysis. When it concerns a foreign Sponsor, the presence of the ICC at the consultation is required.
The ICC is responsible for conducting clinical trial, generally along with a selected CRO, and a broad range of activities such as annual IB review, device accountability and Serious Adverse Events (SAE) reporting to PMDA.
The clinical trial environment in Japan is well developed and need to be conducted in accordance with the Japan GCP Regulation.
Based in Tokyo, Micren is a professional, independent, ICC Service Provider.
Micren Healthcare holds a Type I Marketing Authorization Holder (MAH) license for medical device from the Tokyo Metropolitan Government and as such acts as the Designated Marketing Authorization Holder (DMAH). As a result, Micren Healthcare has extensive experience and expertise in device control and vigilance, including adverse event reporting. This experience allows Micren Healthcare to act as the ICC and control custom clearance, device accountability and Serious Adverse Event (SAE) reporting, in addition to other GCP related activities.
Our goal is to help you conduct clinical trials in Japan in compliance with the Japan GCP Regulation.
As your ICC, we will provide the following services:
- Develop and/or review GCP documents, including the Protocol and Investigator’s Brochure (including annual IB reviews and modifications if applicable) in compliance with Japan GCP Regulation;
- Prepare and participate in the mandatory PMDA Clinical Trial Protocol Consultation;
- Prepare and submit the CTN to PMDA, including a description of the concerned device, and future notices of any pertinent changes;
- Prepare the agreement with the selected investigator(s)/institution(s);
- Assist in the supply and handling of the investigational product(s) to the investigator(s)/institution(s) in accordance with Article 24 of Japan GCP Regulation and other applicable regulations;
- Assist in reviewing events that occurred during the trial to determine if these are reportable to PMDA and/or other authorities;
- Report Serious Adverse Events (SAE) to PMDA;
- Prepare and submit the Clinical Trial Report to PMDA;
- Project management of the clinical trial, including;
- Assist in investigator(s)/institution(s) selection
- Assist to obtain the Institutional Review Board(IRB)/Independent Ethics Committee(IEC) approval, including review and compilation of the documentation to be submitted to IRB/IEC
- Assist in managing the selected CRO to implement quality assurance and quality control procedures and processes
- Allow for the use of our In-Country Caretaker’s name and registered address in Japan on your device labels as required;
- Access to office, phone, fax, mail handling, etc.;
The ICC is an important partner for your company in Japan with significant regulatory responsibilities as required by the Japan GCP Regulation.
Please contact us for more information about In-Country Caretaker (ICC) services for Japan.