ICH E2C
E555158
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.
All labels observed (2)
| Label | Occurrences |
|---|---|
| ICH E2C canonical | 2 |
| ICH E2C(R2) | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5932568 — 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 E2C Context triple: [ICH E2A Clinical Safety Data Management, relatedTo, ICH E2C]
-
A.
ECI
ECI is the independent constitutional authority responsible for administering and supervising elections in India at the national and state levels.
-
B.
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.
-
C.
EIC
EIC is a category of long-distance passenger trains in Poland, offering higher-standard intercity services operated by PKP Intercity.
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D.
ECIT
ECIT is a research institute focused on advancing electronics, communications, and information technology.
-
E.
CECh
CECh is the Spanish acronym for the Episcopal Conference of Chile, the assembly of Catholic bishops responsible for coordinating the pastoral and administrative activities of the Church in Chile.
- 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 E2C Target entity description: 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.
-
A.
ECI
ECI is the independent constitutional authority responsible for administering and supervising elections in India at the national and state levels.
-
B.
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.
-
C.
EIC
EIC is a category of long-distance passenger trains in Poland, offering higher-standard intercity services operated by PKP Intercity.
-
D.
ECIT
ECIT is a research institute focused on advancing electronics, communications, and information technology.
-
E.
CECh
CECh is the Spanish acronym for the Episcopal Conference of Chile, the assembly of Catholic bishops responsible for coordinating the pastoral and administrative activities of the Church in Chile.
- F. None of above. chosen
Statements (41)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
drug safety guideline ⓘ pharmacovigilance guideline ⓘ |
| abbreviationOf | International Council for Harmonisation guideline E2C ⓘ |
| aimsTo |
facilitate global pharmacovigilance
ⓘ
harmonise international requirements for periodic safety update reports ⓘ integrate benefit-risk evaluation into periodic safety reporting ⓘ |
| appliesTo |
human medicinal products
ⓘ
marketed medicinal products ⓘ |
| defines |
content requirements for periodic safety update reports
ⓘ
format for periodic safety update reports ⓘ timing of periodic safety update reports ⓘ |
| focusesOn |
clinical safety data management for marketed drugs
ⓘ
periodic benefit-risk evaluation reports ⓘ periodic safety update reporting of medicinal products ⓘ |
| fullName |
Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
ⓘ
Periodic Benefit-Risk Evaluation Report (PBRER) ⓘ |
| hasRevision |
ICH E2C(R1)
ⓘ
ICH E2C(R2) ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ |
| objective |
improve consistency of safety reporting across regions
ⓘ
provide a common standard for periodic safety update reports ⓘ |
| partOf |
ICH E2 clinical safety guidelines series
ⓘ
linked to:
ICH E2A Clinical Safety Data Management
|
| regulatoryScope |
European Union
ⓘ
ICH regions ⓘ Japan ⓘ United States ⓘ
linked to:
United States of America
|
| relatedTo |
ICH E2A
ⓘ
ICH E2B ⓘ ICH E2D ⓘ ICH E2E ⓘ drug safety reporting ⓘ pharmacovigilance ⓘ regulatory submissions for safety ⓘ |
| revises | ICH E2C ⓘ |
| supersededBy |
ICH E2C(R2)
ⓘ
linked to:
ICH E2C
|
| supports |
ongoing pharmacovigilance
ⓘ
risk management of medicinal products ⓘ |
| 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 E2C Description of subject: 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.
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.
linked to: ICH E2C