CRED Practical Document Writing and Management

Global Dossier

Also referred to as Core / Parent Dossier, Master CTD ● Most ‘current’ CTD documents, most recently approved application ● Internal use only, not for Health Authorities ● Global Dossier used for eCTD, NeeS, CTD and paper submissions ● No regional information (i.e. M2-5 only)

● Regional information prepared by local operating company (LOC) / local affiliate ● Child dossiers made for each country, regional information added by affiliate, M2 summaries and possible quality sections updated ● Updated documents replaced in waves, to track document control ● Majority of organisations base the dossier on the approved EU MAA, as adds the benefits of: – No STF / CRFs – Most current documents (depending on US FDA going first)