Globally, there has been a trend toward using more real-world data in the development of drugs and devices. Japan’s MHLW is also taking note and has drafted 2 new guidelines – 1. A basic policy on using registry data in registration submissions and 2. When using registry data, key points to keep in mind.
These guidelines also suggest when registry data can be used in submissions. They suggest the data can be used in certain cases as an alternative or supplement to clinical studies when evaluating safety and efficacy, in post-marketing evaluations of the safety and efficacy of approved products, as a supplement to the approval of products that have received conditional approval in Japan (regenerative medicine, etc.).
The guideline also says that if applicants use registry data they must ensure that the data is reliable and appropriate.
While still in draft form, the MHLW plans to finalize these guidelines by the first quarter of 2020.