DSM — Marketing Authorisation Dossier
Sixteen authoring and review activities for a Common Technical Document submission in module order, partitioning into a safety-summary, clinical-overview, risk-plan and labelling loop plus a quality and bioequivalence pair.
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title "Marketing authorisation dossier — CTD authoring dependencies"
mode process
convention ir-fad
activities: Target product profile, Quality module 3, Nonclinical overview, Clinical study reports
activities: Integrated summary of safety, Integrated summary of efficacy, Clinical overview
activities: Risk management plan, Paediatric investigation plan, Labelling and SmPC
activities: Patient information leaflet, Environmental risk assessment, Bioequivalence bridging
activities: Module 2 quality summary, Health authority meeting pack, Submission assembly
Quality module 3 <- Target product profile(2), Bioequivalence bridging(2)
Nonclinical overview <- Target product profile, Environmental risk assessment
Clinical study reports <- Target product profile(2)
Integrated summary of safety <- Clinical study reports(3), Risk management plan(2)
Integrated summary of efficacy <- Clinical study reports(3)
Clinical overview <- Integrated summary of safety(3), Integrated summary of efficacy(3), Nonclinical overview(2)
Risk management plan <- Integrated summary of safety(3), Labelling and SmPC(2)
Labelling and SmPC <- Clinical overview(3), Risk management plan(3), Quality module 3(2)
Patient information leaflet <- Labelling and SmPC(3)
Paediatric investigation plan <- Clinical study reports(2), Risk management plan
Bioequivalence bridging <- Quality module 3(2), Clinical study reports
Module 2 quality summary <- Quality module 3(3), Bioequivalence bridging(2)
Health authority meeting pack <- Clinical overview(2), Risk management plan(2), Module 2 quality summary
Submission assembly <- Labelling and SmPC(3), Module 2 quality summary(2), Patient information leaflet(2), Paediatric investigation plan
Environmental risk assessment <- Quality module 3