ICH M4 Common Technical Document
E131971
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.
All labels observed (5)
| Label | Occurrences |
|---|---|
| ICH M4 Common Technical Document canonical | 2 |
| ICH M4 guideline | 1 |
| ICH M4 guidelines | 1 |
| International Council for Harmonisation Common Technical Document | 1 |
| eCTD | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1151209 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH M4 Common Technical Document Context triple: [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, notableWork, ICH M4 Common Technical Document]
-
A.
ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
B.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
-
C.
ISO 26324
ISO 26324 is the international standard that defines the structure, syntax, and functional framework of the Digital Object Identifier (DOI) system for uniquely identifying digital content.
-
D.
World Forum for Harmonization of Vehicle Regulations
The World Forum for Harmonization of Vehicle Regulations is a United Nations working party that develops and updates international technical standards to ensure the safety, environmental performance, and interoperability of motor vehicles and their equipment.
-
E.
IMT Charter
The IMT Charter is the foundational legal document that established the principles, jurisdiction, and procedures of the Nuremberg International Military Tribunal after World War II.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: ICH M4 Common Technical Document Target entity description: 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.
-
A.
ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
B.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
-
C.
ISO 26324
ISO 26324 is the international standard that defines the structure, syntax, and functional framework of the Digital Object Identifier (DOI) system for uniquely identifying digital content.
-
D.
World Forum for Harmonization of Vehicle Regulations
The World Forum for Harmonization of Vehicle Regulations is a United Nations working party that develops and updates international technical standards to ensure the safety, environmental performance, and interoperability of motor vehicles and their equipment.
-
E.
IMT Charter
The IMT Charter is the foundational legal document that established the principles, jurisdiction, and procedures of the Nuremberg International Military Tribunal after World War II.
- F. None of above. chosen
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 of Japan ⓘ Swissmedic ⓘ U.S. Food and Drug Administration ⓘ
linked to:
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 ⓘ
linked to:
United States of America
other ICH member regions ⓘ |
| regulates | pharmaceuticals for human use ⓘ |
| relatedStandard |
eCTD
ⓘ
linked to:
ICH M4 Common Technical Document
|
| 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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: ICH M4 Common Technical Document Description of subject: 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.
Referenced by (6)
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
ⓘ
linked to: ICH M4 Common Technical Document
linked to: ICH M4 Common Technical Document
linked to: ICH M4 Common Technical Document
linked to: ICH M4 Common Technical Document