Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
PMDA to Begin Unannounced Regular Inspections in Wake of GMP Violations by Kaketsuken
The Pharmaceuticals and Medical Devices Agency (PMDA) has decided to conduct unannounced regular inspections of drug makers’ manufacturing facilities. Regular inspections are part of the PMDA’s regime of onsite inspections. The main targets of unannounced inspections will be manufacturing facilities…
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REGULATORY
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