Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
COMMENTARY
Revised PAL to Embrace “Deeper” Safety Measures, Yet Also Escape Clauses to Ease Company Burdens
The Pharmaceutical Affairs Law (PAL) will be amended and renamed the Pharmaceuticals and Medical Devices Law on November 25. The upcoming amendment traces its roots to discussions launched in 2008 by a health ministry panel to investigate drug-induced hepatitis cases,…
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