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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

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UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
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.
UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
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.
UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
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.
UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
PMDA Updates Information on Biosimilars
The Pharmaceuticals and Medical Devices Agency (PMDA) has updated its biosimilars information. Details are available on the PMDA website.
UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
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.
UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
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.
UPDATED
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
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.