ICH M4 Common Technical Document

URI: https://gptkb.org/entity/ICH_M4_Common_Technical_Document
GPTKB entity
Statements (25)
Predicate Object
gptkbp:instanceOf regulatory guideline
pharmaceutical document standard
gptkbp:abbreviation gptkb:CTD
gptkbp:adoptedBy 2000
gptkbp:appliesTo pharmaceuticals for human use
marketing authorization applications
gptkbp:developedBy gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
https://www.w3.org/2000/01/rdf-schema#label ICH M4 Common Technical Document
gptkbp:language English
gptkbp:purpose harmonize submission of regulatory information for pharmaceuticals
gptkbp:relatedTo eCTD
gptkbp:structure Module 2: Common technical document summaries
Module 3: Quality
Module 4: Nonclinical study reports
Module 5: Clinical study reports
Module 1: Administrative information and prescribing information
gptkbp:usedBy gptkb:Swissmedic
gptkb:European_Medicines_Agency
gptkb:Health_Canada
gptkb:U.S._Food_and_Drug_Administration
gptkb:Therapeutic_Goods_Administration_(Australia)
gptkb:Pharmaceuticals_and_Medical_Devices_Agency_(Japan)
gptkbp:website https://www.ich.org/en/ich-guidelines/multidisciplinary/m4-common-technical-document-ctd
gptkbp:bfsParent gptkb:ICH
gptkbp:bfsLayer 6