CRED Getting the CMC Dossier Right 2024

28/08/2024

Common Technical Dossier (CTD)

• CTD – common format for submissions to regulatory authorities in EU, Japan, US • Mandatory format for new drug applications in EU, Japan and US, mandatory for INDs in US

• EU: CTD format → adopted as Notice to Applicants Vol 2B of Eudralex

• Content → legally defined in Annex 1 of Directive 2001/83 as amended by 2003/63.

• eCTD – an electronic version can be produced following guideline ICH M8 – separate guideline

• CTD format divides information into 5 Modules

• (Module 1 is specific to each region – not part of CTD)

The Organisation for Professionals in Regulatory Affairs

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The CTD (ICH M4)

The Organisation for Professionals in Regulatory Affairs

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