On May 9, the MHLW issued a notice that they will accept online applications for drugs, medical devices, and regenerative medicine products. Other types of products that can be submitted online include applications for API master files, GCP/GPSP onsite inspections, and partial modifications to existing approvals, among others. Online submissions will officially start on July 1. After October 1, online submissions for device/drug manufacturing and operator licenses will also begin.
