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In-Country-Caretaker in Japan to Manage Clinical Trial Studies

Yu Kushimoto

By: Yu Kushimoto May 13 2013

Tags: Regulatory Import Export

in country caretaker in Japan

In-Country-Caretaker Required in Japan to Manage Clinical Trial Studies

Knowing how to interact with investigator staff and regulatory authorities is essential when running clinical trials in Japan. It is imperative that the right honorific tone is used during all interactions with parties to the clinical trial, especially from the outset.

It is a mistake to think that a clinical trial in Japan can be completely controlled from an overseas location. While the supply of materials can be successfully controlled from a remote location using local service providers, the submission of the Clinical Trial Notification (CTN) needs to be submitted by a Japanese entity.

The Japanese entity submits the CTN to the PMDA (Pharmaceuticals and Medical Devices Agency). This usually includes a description and product summary, pre-clinical data, the protocol and analysis plan, SOPs, contact list and research institution details. In some instances there are no base-guidelines about what types of foreign clinical data are acceptable for each product. In many cases, the PMDA works on a case-by-case basis for each medical product with independent Japanese experts to determine details of a clinical trial, e.g. number of trial participants, what data is required, how the study should be conducted, duration of the trial.

Once the trial is underway, the quantities on the airway bill must match the quantities in the CTN at the time of import. If not, the customs clearance process can be delayed. The broker will have to ask for a correction which will mean another trip to the customs office.

The Japanese medical business is very sophisticated. Compliance with GCP often requires an Institutional Review Board (IRB) to review the clinical trial protocol, written informed consent forms for participants, etc. The CTN submission must be in the Japanese language and the Japanese entity is responsible for the monitoring of study data, although sometimes they outsource this aspect of the trial to a local CRO.

For further information on the CTN and NDA process and details on how to interact with the PMDA in Japan, please feel free to reach out to me:

 

T: +81 3 6457 0250
E: yu.kushimoto.com

Yu Kushimoto