Regarding review for approval of the marketing of drugs (hereinafter referred to as “approval review”), the “Japan Revitalization Strategy - Japan is BACK -” (adopted by the Cabinet on June 14, 2013) indicates that it is essential to strengthen the system of the Pharmaceuticals and Medical Devices Agency (hereinafter referred to as “PMDA”), and the “Healthcare and Medical Strategy” (an agreement among relevant ministers, June 14, 2013) further states that the PMDA itself shall carry out analyses and research by utilizing clinical data, etc.
Regarding the submission of electronic study data at the time of new drug applications for the marketing of drugs, it has been notified in the “Notification on Handling of Submission of Electronic Study Data for New Drug Applications” (PSEHB/PED Notification No. 0401-10, by the Director of Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated April 1, 2022; hereinafter referred to as “notification on electronic study data”).
Based on the experience of submission of electronic study data, we have decided to revise the notification on electronic study data as shown in the Appendix; therefore, we ask you to inform manufacturers and sellers placed under your administration to utilize them for their business operations.
Please refer to the attached revised notification of electronic study data.
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