Pharmacovigilance Risk Assessment Committee
E130558
The Pharmacovigilance Risk Assessment Committee is a scientific body responsible for evaluating and monitoring the safety of human medicines and advising on risk management measures in the European Union.
All labels observed (3)
How this entity was disambiguated
This entity first appeared as the object of triple T1143216 — 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: Pharmacovigilance Risk Assessment Committee Context triple: [European Medicines Agency, hasCommittee, Pharmacovigilance Risk Assessment Committee]
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A.
Committee for Proprietary Medicinal Products
The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
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B.
Committee for Medicinal Products for Veterinary Use
The Committee for Medicinal Products for Veterinary Use is the European Medicines Agency’s scientific committee responsible for evaluating and providing opinions on veterinary medicines in the European Union.
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C.
Committee for Herbal Medicinal Products
The Committee for Herbal Medicinal Products is a scientific body within the European Medicines Agency that evaluates and provides guidance on the safety and efficacy of herbal medicines in the European Union.
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D.
Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
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E.
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.
- 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: Pharmacovigilance Risk Assessment Committee Target entity description: The Pharmacovigilance Risk Assessment Committee is a scientific body responsible for evaluating and monitoring the safety of human medicines and advising on risk management measures in the European Union.
-
A.
Committee for Proprietary Medicinal Products
The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
-
B.
Committee for Medicinal Products for Veterinary Use
The Committee for Medicinal Products for Veterinary Use is the European Medicines Agency’s scientific committee responsible for evaluating and providing opinions on veterinary medicines in the European Union.
-
C.
Committee for Herbal Medicinal Products
The Committee for Herbal Medicinal Products is a scientific body within the European Medicines Agency that evaluates and provides guidance on the safety and efficacy of herbal medicines in the European Union.
-
D.
Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
-
E.
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.
- F. None of above. chosen
Statements (42)
| Predicate | Object |
|---|---|
| instanceOf |
pharmacovigilance body
ⓘ
scientific committee ⓘ |
| abbreviation | PRAC ⓘ |
| aim |
ensure high level of protection of public health
ⓘ
improve benefit-risk balance of medicines ⓘ |
| collaboratesWith |
Committee for Medicinal Products for Human Use
ⓘ
national competent authorities of EU Member States ⓘ |
| createdBy | European Union pharmacovigilance legislation ⓘ |
| field |
drug safety
ⓘ
pharmacovigilance ⓘ public health ⓘ |
| hasDomain | human medicines ⓘ |
| hasRole |
advisory body to the European Commission on safety of medicines
ⓘ
advisory body to the European Medicines Agency Management Board ⓘ |
| hasScope |
centrally authorised medicines
ⓘ
nationally authorised medicines in the European Union ⓘ |
| hasTask |
advise on communication of safety issues
ⓘ
evaluate signals of new or changing safety issues ⓘ provide recommendations on safety-related regulatory actions ⓘ review risk minimisation measures ⓘ support coordination of EU pharmacovigilance system ⓘ |
| isPartOf | EU regulatory network for medicines ⓘ |
| jurisdiction | European Economic Area ⓘ |
| languageOfWorkOrName | English ⓘ |
| locatedIn |
Amsterdam
ⓘ
Netherlands ⓘ |
| operatesInJurisdiction | European Union ⓘ |
| parentOrganization | European Medicines Agency ⓘ |
| partOf | European Medicines Agency ⓘ |
| regulates | safety monitoring of human medicines in the EU ⓘ |
| responsibleFor |
advising on risk management measures
ⓘ
evaluation of safety of human medicines ⓘ monitoring safety of human medicines ⓘ periodic safety update report assessment ⓘ pharmacovigilance signal assessment ⓘ post-authorisation safety study assessment ⓘ referral procedures related to safety ⓘ risk assessment of medicinal products ⓘ risk management plan assessment ⓘ |
| subjectOf | EU pharmacovigilance legislation ⓘ |
| supervises | pharmacovigilance activities related to authorised medicines ⓘ |
| website | https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac ⓘ |
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: Pharmacovigilance Risk Assessment Committee Description of subject: The Pharmacovigilance Risk Assessment Committee is a scientific body responsible for evaluating and monitoring the safety of human medicines and advising on risk management measures in the European Union.
Referenced by (8)
Full triples — surface form annotated when it differs from this entity's canonical label.
subject surface form:
European Medicines Agency
European Union pharmaceutical legislation
→
monitoredBy
→
Pharmacovigilance Risk Assessment Committee
ⓘ
this entity surface form:
Pharmacovigilance Risk Assessment Committee of the European Medicines Agency
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
→
replaces
→
Pharmacovigilance Risk Assessment Committee
ⓘ
subject surface form:
Pharmacovigilance Risk Assessment Committee
this entity surface form:
Pharmacovigilance Working Party of the CHMP
Committee for Medicinal Products for Human Use
→
worksWith
→
Pharmacovigilance Risk Assessment Committee
ⓘ