Common Technical Document
E555160
The Common Technical Document is a standardized format for regulatory submissions of pharmaceutical product information used across major global health authorities to streamline drug approval processes.
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
pharmaceutical regulatory standard
ⓘ
regulatory submission format ⓘ |
| abbreviation | CTD NERFINISHED ⓘ |
| aimsTo | facilitate mutual acceptance of technical information by regulatory authorities ⓘ |
| appliesTo | pharmaceutical products for human use ⓘ |
| benefit |
facilitates simultaneous submissions to multiple regulatory authorities
ⓘ
improves consistency and quality of regulatory dossiers ⓘ reduces duplication of effort for multinational submissions ⓘ |
| developedBy |
ICH
NERFINISHED
ⓘ
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| distinctionFrom | eCTD is the electronic implementation of the CTD format NERFINISHED ⓘ |
| documentType | structured dossier format ⓘ |
| harmonizationRegion |
Europe
NERFINISHED
ⓘ
Japan NERFINISHED ⓘ United States NERFINISHED ⓘ |
| hasPart |
Module 1
ⓘ
Module 2 ⓘ Module 3 ⓘ Module 4 ⓘ Module 5 ⓘ |
| introducedBy | ICH in early 2000s ⓘ |
| module1Content | regional administrative information and prescribing information ⓘ |
| module2Content | summaries and overviews of quality, nonclinical, and clinical information ⓘ |
| module3Content | quality information including chemistry, manufacturing, and controls ⓘ |
| module4Content | nonclinical study reports ⓘ |
| module5Content | clinical study reports ⓘ |
| purpose |
harmonize the format of regulatory submissions for pharmaceuticals
ⓘ
streamline drug approval processes across regions ⓘ |
| regulatoryArea | human medicines regulation ⓘ |
| relatedTo |
eCTD
NERFINISHED
ⓘ
electronic Common Technical Document ⓘ |
| requires |
clinical efficacy and safety data
ⓘ
comprehensive quality data ⓘ nonclinical safety data ⓘ |
| scope |
biologic license applications
ⓘ
generic drug applications in some regions ⓘ new drug applications ⓘ |
| standardizedBy | ICH M4 guidelines NERFINISHED ⓘ |
| usedBy |
pharmaceutical companies
ⓘ
regulatory authorities ⓘ |
| usedFor |
marketing authorization applications for human medicinal products
ⓘ
regulatory submissions of pharmaceutical product information ⓘ |
| usedIn |
Australia
NERFINISHED
ⓘ
Canada ⓘ European Union NERFINISHED ⓘ Japan NERFINISHED ⓘ Switzerland NERFINISHED ⓘ United States of America ⓘ
surface form:
United States
other ICH regions ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.