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 was expected to improve convenience at the time of submission, but the system simply replaced on-line the submission of applications, notices, etc. prepared using the Ministry of Health, Labour and Welfare's electronic application software for Pharmaceuticals, etc. developed in April 2005. Even when an application is submitted online, a revenue stamp for payment of the fee or a return envelope, such as an approval or certificate issued on paper, is required to be sent by mail. In addition, in the event of a change in the notified matters, etc., a change notice shall be submitted for each item within a certain period of time after the change, with the exception of some cases. Therefore, a large amount of clerical work may occur in a short period of time on both the company side and the administrative side. If the changes are identical, more efficient operation should be possible, for example, by expanding the conditions under which multiple items can be notified of changes in a lump sum. In addition, due to the lack of linkage between prefectural, PMDA and customs systems, procedures are required for the present of notifications and applications related to the manufacturing and marketing of Cosmetics & quasi-drugs, notifications related to export products, and submission of documents required 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.