Online notifications and applications for approval of cosmetics and quasi-drugs

The Government enacted the "Basic Act on the Advancement of Public and Private Sector Data Utilization" in December, 2016, which stipulates the use of necessary measures for determining online usage for administrative procedures in principle. However, in regard to cosmetics and quasi-drugs, notifications and applications have to be made using floppy discs or in paper form. On the other hand, export reports using the NACCS (Nippon Automated Cargo and Port Consolidated System) can be used electronically. Furthermore, the prefectural authorities, the PMDA and Customs are not linked, so separate procedures are required for notification and application concerning the manufacturing and sales of cosmetics and quasi-drugs, and presentation of the necessary material for import customs clearance. In FY2019, MHLW acquired budgets for online application and notification procedures such as pharmaceuticals and medical devices. However, it would be difficult to simplify and expedite the application process simply by submitting the file from the current MHLW version of the software for electronic applications such as medical products without changing the form or the description of the application form and the registration form. The construction of a system which enables efficient administrative procedures which maximises the utilisation of an IT platform is expected.


  • An online notification and application system should be established for submitting Notifications on the Manufacture and Sale of Cosmetics and Applications for Approval of Quasi-Drugs. This system should be linked to the Customs clearance system to provide a one-stop service for application procedures.
  • Improvements should be made to the specifications of the application form, the registration form, and the "MHLW-version software for electronic applications such as medical products" in order to simplify and expedite administrative procedures.