ICH M4 (Common Technical Document)
GPTKB entity
Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory guideline
|
| gptkbp:abbreviation |
gptkb:CTD
|
| gptkbp:adoptedBy |
gptkb:US_Food_and_Drug_Administration
gptkb:European_Medicines_Agency Japanese Pharmaceuticals and Medical Devices Agency |
| gptkbp:appliesTo |
pharmaceutical product registration
|
| gptkbp:firstIssueDate |
2000
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH M4 (Common Technical Document)
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
Japanese other ICH languages |
| gptkbp:purpose |
harmonize the format of regulatory submissions for pharmaceuticals
|
| gptkbp:relatedTo |
ICH Q1-Q10 guidelines
ICH M2 (Electronic Standards for the Transfer of Regulatory Information) |
| 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:website |
https://www.ich.org/en/ich-guidelines/multidisciplinary/m4-common-technical-document
|
| gptkbp:bfsParent |
gptkb:ICH_Guidelines
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use_(ICH) |
| gptkbp:bfsLayer |
7
|