New CDx Requirements In Japan

On March 31, the Japanese MHLW issued a notification allowing CDxs to be used for more than one drug, in addition to the initial treatments they were originally approved for. In the past, different CDxs were available for unique drugs that have identical indications.  Now, under this new MHLW notification, a new category of “cross-pharmaceutical” will allow them to be used for dissimilar drugs that meet certain benchmarks. The Criteria for cross-pharmaceutical products will include – 1. tests from each CDx that show they are acceptable scientifically for various drugs and really help determine eligible patients, 2. that there are many approved CDxs for the same diseases, specimens, and biomarkers, and 3. CDxs are approved in Japan to help determine which patients will be helped by certain drugs. CDX manufacturers that can reach these criteria can then apply for partial changes to their existing approvals and thus use their CDXs with different drugs with different indications.