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23日•1分で読めます
PMDA Approves SHINSA CDx for Identifying Eligible Patients
Japan’s PMDA has approved the SHINSA companion diagnostic (CDx) to help identify patients eligible for specific therapies, updated June 16, 2026.
規制動向
2026年8月23日•1分で読めます
PMDA Follow‑up Alert: Serious Hypocarnitinemia and Hypoglycaemia in Children Treated with Pivoxil‑Group Antibacterials
PMDA issued a follow‑up safety alert about cases of serious hypocarnitinemia and hypoglycaemia in pediatric patients receiving antibacterial drugs containing a pivoxil moiety.
規制動向
2026年8月23日•1分で読めます
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.
規制動向
2026年8月23日•1分で読めます
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.
規制動向
2026年8月23日•1分で読めます
PMDA Posts 2026 No.2 Update
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted its 2026 No.2 update, providing the latest regulatory information for stakeholders.
規制動向
2026年8月23日•1分で読めます
PMDA Issues Press Release on International Pharmacopoeia Activities
The Japan Pharmaceuticals and Medical Devices Agency announced a new press release covering its international pharmacopoeia initiatives.
規制動向
2026年8月23日•1分で読めます
PMDA Publishes English Translation of RiHEART Review Report
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has released an English translation of its review report for the pharmaceutical product RiHEART, available on its website.
規制動向
2026年8月23日•1分で読めます
PMDA Issues Early Guidance on Clinical Evaluation of Factor VIII & IX for Pediatric Hemophilia
The Pharmaceuticals and Medical Devices Agency released early considerations for evaluating blood coagulation factor VIII and IX products in children with congenital hemophilia.
規制動向
2026年8月23日•1分で読めます
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.
規制動向
2026年8月23日•1分で読めます
ASEAN-Japan Medical Devices Regulatory Seminar 2026 Announced
The Pharmaceuticals and Medical Devices Agency (PMDA) has announced the ASEAN-Japan Medical Devices Regulatory Seminar for 2026, aimed at fostering regulatory collaboration.
規制動向
2026年8月23日•1分で読めます
PMDA Opens Applications for 2026 Blood Products Seminar (PPWG)
The Pharmaceuticals and Medical Devices Agency (PMDA) announced that applications are now open for the 2026 PMDA-ATC Blood Products Seminar for PPWG.
規制動向
2026年8月23日•1分で読めます
PMDA Publishes Report on ASEAN-Japan Medical Devices Regulatory Symposium 2026
The Pharmaceuticals and Medical Devices Agency (PMDA) has released a report on the ASEAN-Japan Medical Devices Regulatory Symposium held in 2026, detailing regulatory discussions and outcomes.