Regulatory Updates
Aug 23, 2026•1 min read
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.
Regulatory Updates
Aug 23, 2026•1 min read
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.
Regulatory Updates
Aug 23, 2026•1 min read
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.
Regulatory Updates
Aug 23, 2026•1 min read
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.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Releases English Translation of Review Report for Optune Lua and Esprit BTK Scaffold System
The Japanese PMDA has published an English translation of its review report for the Optune Lua and Esprit BTK Everolimus eluting resorbable scaffold system.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes English Review Report for Beovu Partial Change Approval
The Pharmaceuticals and Medical Devices Agency (PMDA) has released an English translation of its review report concerning the partial change approval of the ophthalmic drug Beovu.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Revises Precautions for Donanemab and Other Drugs
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted updated precautionary information for Donanemab and other medicines.
Regulatory Updates
Aug 23, 2026•1 min read
Fresenius Medical Care Deutschland GmbH Reports Braille Label Error
Fresenius Medical Care Deutschland GmbH identified an error in the Braille printing on the outer label of its product, as noted in an MHRA alert.
Regulatory Updates
Aug 23, 2026•1 min read
Crescent Pharma Initiates Precautionary Recall of Ramipril 2.5 mg Capsules
Crescent Pharma Limited is recalling a batch of 2.5 mg Ramipril capsules due to a possible packaging error.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA releases Field Safety Notices for 25‑29 May 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a list of field safety notices covering the period 25 to 29 May 2026.
1
Regulatory Updates
Aug 23, 2026•1 min read
MHRA publishes Field Safety Notices for 27‑31 July 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 27 to 31 July 2026.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Issues Updated Guidance on Defects in Belzer Organ Preservation Solutions
The MHRA has issued an updated Drug Safety Information (DSI) replacing DSI/2023/005, addressing defects in Belzer solutions used for organ preservation.