Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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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