Regulatory Updates
Latest changes across tracked markets
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Showing 5 of 13 updates
April 2026
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CMS announces Medicare negotiation prices for 2027 cohort
15 additional Part D drugs selected for IRA price negotiation effective January 2027.
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MHRA expands International Recognition Procedure
MHRA adds new reference regulators eligible for IRP submissions, broadening reliance scope.
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EU Joint Clinical Assessment expands to ATMPs
Joint Clinical Assessment under EU HTA Regulation now applies to advanced therapies.
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SFDA revises annual product renewal fees
Annual MA renewal fee schedule updated effective Q3 2026.
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ANVISA issues optimised analysis guidance update
RDC 205/2017 supplementary guidance clarifies AREE-based reliance dossier requirements.
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