Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Kaketsuken-Like Cases Seen Outside Japan Too, Many Exposed through Tip-Offs: PMDA
Regulatory authorities in major markets outside Japan have seen drug makers commit data cover-ups and record tampering, like Kaketsuken’s GMP violation case in Japan, with many laid bare by whistleblowers, according to the Pharmaceuticals and Medical Devices Agency (PMDA). Tomiko…
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REGULATORY
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…