ICH M4 Common Technical Document

E131971

ICH guideline regulatory guideline technical document format

ICH M4 Common Technical Document is an internationally harmonized format and set of guidelines for organizing and submitting regulatory information on the quality, safety, and efficacy of pharmaceuticals to health authorities.

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All labels observed (2)

Label	Occurrences
ICH M4 Common Technical Document canonical	2
eCTD	1

Statements (57)

Predicate	Object
instanceOf	ICH guideline ⓘ regulatory guideline ⓘ technical document format ⓘ
abbreviation	ICH ⓘ
adoptedBy	European Medicines Agency ⓘ Health Canada ⓘ Pharmaceuticals and Medical Devices Agency Japan ⓘ surface form: Pharmaceuticals and Medical Devices Agency of Japan Swissmedic ⓘ Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration many other national regulatory authorities ⓘ
alsoKnownAs	Common Technical Document ⓘ ICH CTD ⓘ
appliesTo	biologic license applications ⓘ generic drug applications ⓘ marketing authorization applications ⓘ new drug applications ⓘ post-approval submissions ⓘ
developedBy	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ
goal	to improve efficiency of regulatory review ⓘ to promote global development of medicines ⓘ
governedBy	ICH Management Committee ⓘ
guidelineNumber	M4 ⓘ
hasScope	administrative and prescribing information ⓘ efficacy ⓘ quality ⓘ safety ⓘ
hasSubGuideline	M4E ⓘ M4Q ⓘ M4S ⓘ
language	English ⓘ
M4EScope	clinical overview and clinical summaries ⓘ
M4QScope	quality overall summary and quality module ⓘ
M4SScope	nonclinical overview and nonclinical summaries ⓘ
module1Content	regional administrative information ⓘ
module2Content	summaries and overviews ⓘ
module3Content	quality information ⓘ
module4Content	nonclinical study reports ⓘ
module5Content	clinical study reports ⓘ
purpose	to facilitate simultaneous submission to multiple regulatory authorities ⓘ to harmonize the format of regulatory submissions for pharmaceuticals ⓘ to reduce duplication of effort in preparing regulatory dossiers ⓘ
region	European Union ⓘ Japan ⓘ United States of America ⓘ surface form: United States other ICH member regions ⓘ
regulates	pharmaceuticals for human use ⓘ
relatedStandard	ICH M4 Common Technical Document self-linksurface differs ⓘ surface form: eCTD
structureIncludes	Module 1 ⓘ Module 2 ⓘ Module 3 ⓘ Module 4 ⓘ Module 5 ⓘ
supports	electronic Common Technical Document ⓘ
usedBy	biotechnology companies ⓘ pharmaceutical companies ⓘ regulatory affairs professionals ⓘ regulatory authorities in ICH regions ⓘ

Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use → notableWork → ICH M4 Common Technical Document ⓘ

ICH → notableGuideline → ICH M4 Common Technical Document ⓘ

ICH M4 Common Technical Document → relatedStandard → ICH M4 Common Technical Document self-linksurface differs ⓘ

this entity surface form: eCTD