Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
“Annual Reports” Allowed for CMC Changes with Minimal Impact: MHLW
Drug manufacturers will be allowed to submit “annual reports” rather than the current “minor change notifications” when their proposed post-approval manufacturing changes have a relatively minor impact on product quality, according to the health ministry. This rule change is included…
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REGULATORY
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Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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