ICH E2D
E559691
ICH E2D is an International Council for Harmonisation guideline that provides standards for post-approval safety data management, including the collection, evaluation, and reporting of safety information for marketed medicinal products.
All labels observed (1)
| Label | Occurrences |
|---|---|
| ICH E2D canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5932569 — 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 E2D Context triple: [ICH E2A Clinical Safety Data Management, relatedTo, ICH E2D]
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A.
ICH E2A
ICH E2A is an International Council for Harmonisation guideline that standardizes clinical safety data management and expedited reporting of adverse drug reactions in clinical trials.
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B.
ICH E2C
ICH E2C is an International Council for Harmonisation guideline that defines standards for the periodic safety update reporting of medicinal products to support ongoing pharmacovigilance and risk management.
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C.
EIDE
EIDE (Enhanced Integrated Drive Electronics) is an improved version of the IDE interface standard used to connect storage devices like hard drives and optical drives to a computer’s motherboard.
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D.
E-27
E-27 is the station code assigned to one of the platforms or lines serving Tokyo’s major transit hub, Shinjuku Station.
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E.
EIC
EIC is the common abbreviation for the British East India Company, the powerful trading corporation that played a central role in establishing British rule in India.
- 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 E2D Target entity description: ICH E2D is an International Council for Harmonisation guideline that provides standards for post-approval safety data management, including the collection, evaluation, and reporting of safety information for marketed medicinal products.
-
A.
ICH E2A
ICH E2A is an International Council for Harmonisation guideline that standardizes clinical safety data management and expedited reporting of adverse drug reactions in clinical trials.
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B.
ICH E2C
ICH E2C is an International Council for Harmonisation guideline that defines standards for the periodic safety update reporting of medicinal products to support ongoing pharmacovigilance and risk management.
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C.
EIDE
EIDE (Enhanced Integrated Drive Electronics) is an improved version of the IDE interface standard used to connect storage devices like hard drives and optical drives to a computer’s motherboard.
-
D.
E-27
E-27 is the station code assigned to one of the platforms or lines serving Tokyo’s major transit hub, Shinjuku Station.
-
E.
EIC
EIC is the common abbreviation for the British East India Company, the powerful trading corporation that played a central role in establishing British rule in India.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmacovigilance guideline ⓘ |
| abbreviationOf | International Council for Harmonisation Guideline E2D ⓘ |
| addresses |
definitions related to post-approval safety data
ⓘ
expedited reporting time frames ⓘ follow-up of safety reports ⓘ literature case reporting ⓘ minimum information for a valid individual case safety report ⓘ reporting of safety information from compassionate use or named-patient programs ⓘ reporting of safety information from non-interventional studies ⓘ reporting of safety information from post-authorization studies ⓘ reporting of safety information from registries ⓘ reporting of safety information from special situations such as pregnancy and overdose ⓘ unlisted and serious adverse reactions ⓘ |
| appliesTo |
clinical trial safety reports after marketing authorisation
ⓘ
marketed medicinal products ⓘ post-marketing individual case safety reports ⓘ spontaneous reports of adverse drug reactions ⓘ |
| covers |
company and regulatory responsibilities for safety data management
ⓘ
data quality and completeness in safety reports ⓘ electronic and paper-based safety reporting ⓘ handling of duplicate reports ⓘ |
| defines |
criteria for expedited reporting of individual case safety reports
ⓘ
standards for collection of post-marketing safety data ⓘ standards for evaluation of post-marketing safety data ⓘ standards for reporting of post-marketing safety data ⓘ |
| domain |
drug safety regulation
ⓘ
pharmacovigilance ⓘ |
| focusesOn |
expedited reporting of safety information
ⓘ
post-approval safety data management ⓘ safety information for marketed medicinal products ⓘ |
| fullName | ICH Harmonised Tripartite Guideline E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ |
| objective |
to harmonise international standards for post-approval safety reporting
ⓘ
to improve consistency of expedited safety reporting across regions ⓘ to support protection of public health through timely safety communication ⓘ |
| regulatoryRegion |
European Union
ⓘ
ICH regions ⓘ Japan ⓘ United States ⓘ
linked to:
United States of America
|
| relatedTo |
ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ⓘ
linked to:
ICH E2A Clinical Safety Data Management
ICH E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports ⓘ ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER) ⓘ ICH E2E Pharmacovigilance Planning ⓘ |
| status | harmonised guideline ⓘ |
| usedBy |
marketing authorisation holders
ⓘ
pharmaceutical companies ⓘ regulatory authorities ⓘ |
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 E2D Description of subject: ICH E2D is an International Council for Harmonisation guideline that provides standards for post-approval safety data management, including the collection, evaluation, and reporting of safety information for marketed medicinal products.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.