Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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