electronic Common Technical Document
GPTKB entity
Statements (40)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory submission format
|
| gptkbp:abbreviation |
eCTD
|
| gptkbp:appliesTo |
biologics license applications
new drug applications marketing authorization applications generic drug applications |
| gptkbp:contains |
Module 1
Module 2 Module 3 Module 4 Module 5 |
| gptkbp:developedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:enables |
life cycle management of submissions
|
| gptkbp:firstReleased |
2002
|
| gptkbp:format |
XML backbone
|
| gptkbp:hasVersion |
v3.2.2
|
| https://www.w3.org/2000/01/rdf-schema#label |
electronic Common Technical Document
|
| gptkbp:language |
English
Japanese other ICH region languages |
| gptkbp:purpose |
facilitate electronic submission and review of regulatory documents
|
| gptkbp:relatedTo |
Common Technical Document
|
| gptkbp:replacedBy |
paper Common Technical Document
|
| gptkbp:requires |
EMA for centralized procedure
FDA for NDA, ANDA, BLA submissions Health Canada for NDS, SNDS PMDA for NDA, sNDA |
| gptkbp:standardizedBy |
gptkb:ICH
|
| gptkbp:supports |
hyperlinks
metadata document granularity |
| gptkbp:usedBy |
gptkb:PMDA
gptkb:FDA gptkb:EMA gptkb:Health_Canada |
| gptkbp:usedFor |
regulatory submissions
|
| gptkbp:usedIn |
pharmaceutical industry
|
| gptkbp:website |
https://www.ich.org/page/ectd
|
| gptkbp:bfsParent |
gptkb:New_Drug_Application
|
| gptkbp:bfsLayer |
7
|