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Companies currently reformat the same evidence for every country; a single machine-readable dossier that every regulator reads from would save years of work.
ICH M4 (the Common Technical Document) harmonised the outline but not the practice: sponsors still produce dozens of regional variants and submit through separate gateways. The proposal is a shared, permissioned cloud repository holding a single eCTD v4 dossier with structured CDISC clinical data, to which any participating regulator is granted read access on the sponsor's instruction, with region-specific content limited to an annex. Regulators would query the same data and share questions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions.
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