規制動向
FDA、EMA、TGA および世界の規制動向
規制動向
2026年8月24日•1分で読めます
PMDA Updates Japanese Pharmacopoeia with PDG Harmonized Texts
PMDA announces incorporation of PDG harmonized texts into the Japanese Pharmacopoeia General Chapters, reflecting alignment with international standards.
1
規制動向
2026年8月24日•1分で読めます
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.
規制動向
2026年8月24日•1分で読めます
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.
規制動向
2026年8月24日•1分で読めます
PMDA Posts Schedule for JP19‑I Publication
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the schedule for the upcoming JP19‑I publication.
1
規制動向
2026年8月24日•1分で読めます
PMDA Hokuriku Branch Holds 10th Anniversary Symposium
The Pharmaceuticals and Medical Devices Agency announces a symposium to mark the 10th anniversary of its Hokuriku Branch.
規制動向
2026年8月24日•1分で読めます
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.
規制動向
2026年8月24日•1分で読めます
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.
規制動向
2026年8月24日•1分で読めます
PMDA Publishes Updated List of Approved Medical Devices (Apr 2004‑Sep 2025)
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted an updated list of approved medical devices covering April 2004 to September 2025.
規制動向
2026年8月24日•1分で読めます
PMDA Announces PDG March 2026 News
The Pharmaceuticals and Medical Devices Agency (PMDA) posted its PDG March 2026 news on June 12, 2026.
規制動向
2026年8月24日•1分で読めます
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.
規制動向
2026年8月23日•1分で読めます
PMDA Posts Report from Asia Office GCP Workshop 2026
The Pharmaceuticals and Medical Devices Agency has posted the report from its 2026 Asia office GCP workshop.
規制動向
2026年8月23日•1分で読めます
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.