Regulatory Updates

The PMDA and Toyama Prefecture hosted a symposium celebrating the Hokuriku Branch’s 10th anniversary, highlighting regulatory training and collaboration across Asia.

The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.

The PMDA outlines how to submit comments on draft regulatory science standards, noting email formatting, public disclosure of submissions, and no individual replies.

PMDA outlines resources, consultations, and guidelines to support developers of software as a medical device (SaMD) in Japan.

The PMDA and Japan's Ministry of Health, Labour and Welfare provide a webpage with drug risk information under review, noting possible translation inaccuracies and untranslated files.

The PMDA published seven English translations of notifications and administrative notices related to pediatric drug development, including a revision of the planning guidance for adult drug programs.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced the launch of its new “Designation / Early Access” website, providing information on early access pathways.

The Pharmaceuticals and Medical Devices Agency (PMDA) has launched a new website offering an overview of Japan’s orphan drug designation process.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the schedule for the upcoming JP19‑I publication.

The Pharmaceuticals and Medical Devices Agency announces a symposium to mark the 10th anniversary of its Hokuriku Branch.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report from the PMDA-ATC 10th Anniversary Ceremony.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced a new project team to develop guiding principles for AI utilization, listed under its “Projects Across Multi‑Offices” initiative.