Regulatory Updates
Aug 24, 2026•1 min read
FDA Recall Notice: Some Bottles May Contain Mixed Strengths
The FDA reports that certain bottles may contain mixed strengths of the product, prompting a recall.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Launches New “Designation / Early Access” Website
The Pharmaceuticals and Medical Devices Agency (PMDA) announced the launch of its new “Designation / Early Access” website, providing information on early access pathways.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Launches New “Overview of Orphan Drug Designation” Website
The Pharmaceuticals and Medical Devices Agency (PMDA) has launched a new website offering an overview of Japan’s orphan drug designation process.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Posts Schedule for JP19‑I Publication
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the schedule for the upcoming JP19‑I publication.
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Regulatory Updates
Aug 24, 2026•1 min read
PMDA Posts Report on 10th Anniversary of PMDA-ATC Ceremony
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report from the PMDA-ATC 10th Anniversary Ceremony.
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Regulatory Updates
Aug 24, 2026•1 min read
PMDA Adds Project Team for AI Utilization Guiding Principles
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.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Announces PDG March 2026 News
The Pharmaceuticals and Medical Devices Agency (PMDA) posted its PDG March 2026 news on June 12, 2026.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Asia Office GMP Workshop Training 2026 Report Published
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report for its 2026 Asia Office GMP Workshop Training.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes List of Approved Drugs (April 2004 – Feb 2026)
Japan’s Pharmaceuticals and Medical Devices Agency has released an updated list of drugs approved from April 2004 through February 2026. The list is available on the PMDA website.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Concludes MoU with Medical University of Vienna
The Pharmaceuticals and Medical Devices Agency (PMDA) announced the conclusion of a Memorandum of Understanding with the Medical University of Vienna, as detailed in a June 30, 2026 news release.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Releases Safety Information No.429 for Pharmaceuticals and Medical Devices
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted Safety Information No.429, providing recent safety updates for drugs and devices in Japan.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Posts Summary of 8th Asian Network Meeting
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the summary of the 8th Asian Network Meeting on its website.