ICH CTD
E555159
ICH CTD is an internationally harmonized format for organizing and submitting regulatory information on the quality, safety, and efficacy of pharmaceuticals to health authorities.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmaceutical regulatory standard ⓘ regulatory submission format ⓘ |
| abbreviationOf | Common Technical Document NERFINISHED ⓘ |
| alsoKnownAs | Common Technical Document for the Registration of Pharmaceuticals for Human Use NERFINISHED ⓘ |
| appliesTo |
biotechnological products
ⓘ
marketing authorization applications ⓘ new drug applications ⓘ pharmaceuticals for human use ⓘ |
| benefit |
facilitates simultaneous submissions to multiple regions
ⓘ
reduces duplication of effort in preparing regulatory dossiers ⓘ supports regulatory convergence and harmonization ⓘ |
| component |
Module 1
ⓘ
Module 2 ⓘ Module 3 ⓘ Module 4 ⓘ Module 5 ⓘ |
| developedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| distinguishedFrom | eCTD (electronic Common Technical Document) NERFINISHED ⓘ |
| focus | content and structure of dossiers rather than electronic transmission format ⓘ |
| fullName | International Council for Harmonisation Common Technical Document NERFINISHED ⓘ |
| geographicalUse |
Australia
NERFINISHED
ⓘ
Canada NERFINISHED ⓘ European Union NERFINISHED ⓘ Japan NERFINISHED ⓘ Switzerland NERFINISHED ⓘ United States NERFINISHED ⓘ many other ICH and non-ICH member countries ⓘ |
| module1Content | regional administrative and prescribing information ⓘ |
| module2Content | summaries and overviews of quality, nonclinical, and clinical information ⓘ |
| module3Content | quality information (chemistry, manufacturing, and controls) ⓘ |
| module4Content | nonclinical study reports ⓘ |
| module5Content | clinical study reports ⓘ |
| purpose |
to facilitate simultaneous submission of marketing applications to multiple regulatory authorities
ⓘ
to harmonize the format and structure of regulatory submissions for pharmaceuticals ⓘ |
| regulatoryArea |
drug registration
ⓘ
pharmaceutical product licensing ⓘ |
| regulatoryUse |
new marketing authorization applications
ⓘ
supplemental applications ⓘ variations and line extensions ⓘ |
| relatedStandard |
ICH M4 guideline
NERFINISHED
ⓘ
eCTD NERFINISHED ⓘ |
| scope | quality, safety, and efficacy information of pharmaceuticals ⓘ |
| status | widely adopted international standard for pharmaceutical submissions ⓘ |
| structure | common format for table of contents and document organization ⓘ |
| targetAudience |
pharmaceutical companies
ⓘ
regulatory affairs professionals ⓘ regulatory authorities ⓘ |
Referenced by (1)
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