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

In accordance with the Digital Procedures Act, MHLW began operating online submissions in May 2021 for certain notifications or applications related to quasi-drugs and cosmetics, which had previously been required to be submitted using floppy disks and other storage media. From July 2022, the scope of operations for online submissions has been gradually expanded. This system is expected to improve the convenience of submissions, but this system simply replaces the submissions of applications, notices, etc. prepared using the MHLW’s electronic application software for pharmaceuticals, etc., which was developed in April 2005, on-line. 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. It is hoped that the establishment of a system that enables the simplification and streamlining of administrative procedures for cosmetics & quasi-drugs permitting and import procedures will lead to the realisation of "digitalisation," which is stated in the national digital governance action plan.