Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
E130559
The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Pharmacovigilance Risk Assessment Committee | 1 |
| Pharmacovigilance Risk Assessment Committee within the European Medicines Agency canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1143273 — 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 within the European Medicines Agency Context triple: [Regulation (EC) No 726/2004, establishes, Pharmacovigilance Risk Assessment Committee within the European Medicines Agency]
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A.
European Medicines Agency
The European Medicines Agency is the European Union’s regulatory authority responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use.
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B.
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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C.
European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare is a Council of Europe body responsible for developing quality standards and guidance to ensure the safety and efficacy of medicines and improve healthcare across member states.
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D.
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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E.
UK Medicines and Healthcare products Regulatory Agency
The UK Medicines and Healthcare products Regulatory Agency is the United Kingdom’s national authority responsible for regulating medicines, medical devices, and healthcare products to ensure their safety, quality, and effectiveness.
- 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 within the European Medicines Agency Target entity description: The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
-
A.
European Medicines Agency
The European Medicines Agency is the European Union’s regulatory authority responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use.
-
B.
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.
-
C.
European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare is a Council of Europe body responsible for developing quality standards and guidance to ensure the safety and efficacy of medicines and improve healthcare across member states.
-
D.
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.
-
E.
UK Medicines and Healthcare products Regulatory Agency
The UK Medicines and Healthcare products Regulatory Agency is the United Kingdom’s national authority responsible for regulating medicines, medical devices, and healthcare products to ensure their safety, quality, and effectiveness.
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
pharmacovigilance committee
ⓘ
regulatory body ⓘ scientific committee ⓘ |
| abbreviation | PRAC ⓘ |
| composedOf |
healthcare professional representatives
ⓘ
patient representatives ⓘ pharmacovigilance experts ⓘ representatives of EU Member States ⓘ |
| country | European Union ⓘ |
| field |
drug safety
ⓘ
pharmacovigilance ⓘ public health ⓘ regulatory science ⓘ |
| goal | protect public health by ensuring safe use of medicines in the EU ⓘ |
| hasRole |
advise on post-authorisation safety studies
ⓘ
advise other EMA committees on safety issues ⓘ assess pharmacovigilance data ⓘ assess risk management systems ⓘ assess signals of new or changing safety issues ⓘ conduct safety referrals ⓘ contribute to communication of safety information to the public ⓘ coordinate EU pharmacovigilance activities ⓘ evaluate safety of human medicines ⓘ monitor safety of medicines in the EU ⓘ provide recommendations on risk communication ⓘ provide recommendations on risk minimisation measures ⓘ review periodic safety update reports ⓘ review risk management plans ⓘ support benefit–risk assessment of medicines ⓘ |
| headquartersLocation |
Amsterdam
ⓘ
Netherlands ⓘ |
| inception | 2012 ⓘ |
| jurisdiction |
European Economic Area
ⓘ
European Union ⓘ |
| language | English ⓘ |
| legalBasis |
Directive 2001/83/EC
ⓘ
EU pharmacovigilance legislation ⓘ Regulation (EC) No 726/2004 ⓘ pharmacovigilance legislation adopted in 2010 ⓘ |
| meetsFrequency | monthly ⓘ |
| parentOrganization | European Medicines Agency ⓘ |
| partOf | European Medicines Agency ⓘ |
| replaces |
Pharmacovigilance Working Party of the CHMP
ⓘ
linked to:
Pharmacovigilance Risk Assessment Committee
|
| scope |
centrally authorised medicines
ⓘ
nationally authorised medicines ⓘ |
| website | https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac ⓘ |
| worksWith |
Committee for Medicinal Products for Human Use
ⓘ
Coordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ national competent authorities in EU Member States ⓘ |
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 within the European Medicines Agency Description of subject: The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
Regulation (EC) No 726/2004
→
establishes
→
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
ⓘ