Japan CDx Registration

As medical care becomes more personalized, more drug companies are looking to utilize CDx’s to determine which patients will be responsive to their drugs.

Unlike the US and EU, CDx registration is relatively new in Japan.

In Japan, the first PMDA notification and definition of a CDx was issued in July 2013. Since then, additional notifications have been issued which include the following information:

  • December 24, 2013: Technical guidance for CDx
  • February 19, 2014 and March 28, 2014: Documents that need to be included in a CDx application form
  • July 3, 2018: More details on what needs to be included for CDx registration and how CDx and drug manufacturers should cooperate for Japan registration

Well-known Western CDx companies that have registered their products in Japan include Myriad, Foundation One, and Guardant.

When trying to register a CDx in Japan, the questions below need to be considered:

  • Where will the test be performed?
  • Will a specific or unique collection kit be needed to collect samples?
  • If your test is done in Japan or the West, who will collect these samples and send them to the lab?
  • Will a Japanese doctor be needed to interpret the CDx test results?
  • How will your CDx be reimbursed in Japan?

To get these questions answered and to learn more about registering your CDx in Japan, several PMDA consultation meetings will normally be required.

Pacific Bridge Medical has worked with a number of Western CDx companies to address the above issues and register CDx products in Japan. Please contact us to learn more.