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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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Regulatory Updates
Aug 24, 2026•1 min read
MHRA Publishes Summary of Recent Medicine and Device Safety Letters
The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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.
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Regulatory Updates
Aug 24, 2026•1 min read
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.
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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.
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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.
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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.
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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.
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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.
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Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes List of Approved Regenerative Medical Products (Apr 2015–May 2026)
The Japanese Pharmaceuticals and Medical Devices Agency has released an updated list of regenerative medical products approved between April 2015 and May 2026.
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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.
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Regulatory Updates
Aug 23, 2026•1 min read
MHRA Issues April 2026 Safety Advice for Medicines and Devices
The UK MHRA released its April 2026 safety roundup, summarising the latest advice for medicine and medical device users.
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UPDATED
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.