Japan Revises GCP For Medical Devices and Drugs

In November 2008, Japan’s Ministry of Health, Labor and Welfare (MHLW) released its slated 2009 revisions to the Good Clinical Practice (GCP) standards governing clinical trials for medical devices in Japan. Almost identical revisions to GCP for drugs were implemented in April 2008.

Currently, clinical trials in Japan are extremely expensive, partly because Japan is a high-cost country and partly because of burdensome regulations. For example, the qualifications medical institutions must meet to conduct clinical trials are very high. While clinical trials throughout Asia usually cost less than they would in the US or Europe, in Japan they often cost more. The new device and drug GCP rules have two measures allowing more subcontracting in clinical trials. These measures may reduce clinical trial costs in Japan somewhat.

The first change is regarding Institutional Review Boards (IRBs). Previously, medical institutions conducting clinical trials were obligated to set up and maintain their own IRBs internally, which can be expensive. With the new changes, a medical institution’s director can designate an outside IRB to perform this task instead. This IRB must be part of a university, nonprofit company, or independent government agency, not a for-profit company. To preserve IRB transparency while making this change, the rules also add new reporting requirements. IRBs must make publicly available their internal procedures, members’ names, and summaries of meeting minutes.

The second change is regarding the physical handling of investigational products. Previously, the shipping of investigational devices and drugs (including confirmation of receipt and quality management) had to be performed directly by those running the clinical trial. Now, the trial sponsor can designate a third party to perform these tasks.

The new medical device GCP standards will take effect on April 1, 2009. However, the part adding new reporting requirements for IRBs will not take effect until April 1, 2010.