Preparing for eCTD 4.0 compliance

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By as soon as 2026, Regulatory bodies around the world will start to require compliance with the more recently finalised and published eCTD 4.0 dossier submissions standard(s) (details can be found on the ICH website (1)). Up to then, compliance is largely voluntary across international markets, but between 2026 and 2029, the new requirements will start to be enforced. Unless they are properly geared up for the new requirements before then, pharma companies risk not being able to get new drugs authorised, or changes to existing drugs approved, in some major markets internationally.