Challenge applications and re-evaluation based on real-world clinical data

There was some progress in relaxing the requirements for challenge applications, as it became possible to use already initiated overseas studies, retrospective studies, RWD analyses, investigator-initiated studies and the like, provided that scientific validity is ensured. However, there was no progress on the request to assign product-specific claims codes to eligible products, and establishing the infrastructure needed to track product use and patient progress from real-world clinical data remains an issue.