Recent US – Japan talks have led to discussions on shortening approval times and application processes for medical products. In many cases, medical devices not needing clinical trials in other countries like the US will require clinical testing in Japan, and even small changes in products can lead to a whole new re-registration process. Industry members are now working with the two governments to see how approval times can be cut.
The MHLW had proposed a 5-year strategy in 2007 to help introduce new innovative medical devices and drugs faster into the Japanese market. More recently in August 2008, the MHLW issued a follow-up draft report outlining similar points such as increasing the number of reviewers, establishing clearer review standards and guidelines, and streamlining product approval processes.
The MHLW is also working on some relaxation of partial change requirements. The MHLW has announced that it will not require review or re-approval for partial changes to some medical products, if the partial change does not affect safety or clinical trial results. At this time, the MHLW has not made any further clarifications on what kinds of partial changes will be affected.
The MHLW has also posted a new rule on government reimbursement for advanced medical technology in March 31, 2008. Under the new rule, certain medical institutions will be able to use unapproved medical product in combination with approved medical devices and the approved product portion will be reimbursed. However, patients will still have to pay out-of-pocket for the unapproved medical product portion. Previously, if an approved medical device was used with an unapproved medical product, then patients could not even get reimbursed for the approved medical device portion.
Japanese physicians have been able to import some unapproved medical products through personal import with their doctor’s license. However, this new rule is for certain qualified medical institutions and not individual doctors. Medical institutions can now apply to use these types of combination products and then get reimbursed on the approved product portion.
In addition, the MHLW has suggested that the data gathered during the combined usage of these types of products could potentially be used toward product registration of the unapproved medical product.