Paediatric Regulation
E130568
The Paediatric Regulation is a European Union law designed to improve the development and availability of medicines specifically adapted for use in children.
All labels observed (3)
| Label | Occurrences |
|---|---|
| Paediatric Regulation canonical | 3 |
| Paediatric Investigation Plan for new indications | 1 |
| Regulation (EC) No 1901/2006 on medicinal products for paediatric use | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1143448 — 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: Paediatric Regulation Context triple: [Paediatric Committee, legalBasis, Paediatric Regulation]
-
A.
Paediatric Committee
The Paediatric Committee is a scientific body within the European Medicines Agency responsible for assessing and promoting the development and safe use of medicines for children in the European Union.
-
B.
Convention on the Rights of the Child
The Convention on the Rights of the Child is a landmark United Nations human rights treaty that sets out the civil, political, economic, social, and cultural rights of all children worldwide.
-
C.
Pediatrics
Pediatrics is a leading peer-reviewed medical journal focusing on the health care and research of infants, children, and adolescents.
-
D.
Children Act 2004
The Children Act 2004 is a key piece of UK legislation that reformed children’s services and safeguarding arrangements in England, promoting inter-agency cooperation and the welfare of children.
-
E.
Consumer Product Safety Act provisions
The Consumer Product Safety Act provisions are a set of U.S. federal laws that establish safety standards, regulatory authority, and enforcement mechanisms to protect the public from unreasonable risks of injury associated with consumer products.
- 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: Paediatric Regulation Target entity description: The Paediatric Regulation is a European Union law designed to improve the development and availability of medicines specifically adapted for use in children.
-
A.
Paediatric Committee
The Paediatric Committee is a scientific body within the European Medicines Agency responsible for assessing and promoting the development and safe use of medicines for children in the European Union.
-
B.
Convention on the Rights of the Child
The Convention on the Rights of the Child is a landmark United Nations human rights treaty that sets out the civil, political, economic, social, and cultural rights of all children worldwide.
-
C.
Pediatrics
Pediatrics is a leading peer-reviewed medical journal focusing on the health care and research of infants, children, and adolescents.
-
D.
Children Act 2004
The Children Act 2004 is a key piece of UK legislation that reformed children’s services and safeguarding arrangements in England, promoting inter-agency cooperation and the welfare of children.
-
E.
Consumer Product Safety Act provisions
The Consumer Product Safety Act provisions are a set of U.S. federal laws that establish safety standards, regulatory authority, and enforcement mechanisms to protect the public from unreasonable risks of injury associated with consumer products.
- F. None of above. chosen
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
pharmaceutical legislation ⓘ |
| adoptedBy | European Parliament and Council of the European Union ⓘ |
| aimsTo |
avoid unnecessary clinical trials in children
ⓘ
ensure medicines used in children are subject to high quality research ⓘ improve development of medicines for children ⓘ improve information on medicines used in children ⓘ increase availability of medicines for paediatric use ⓘ |
| appliesTo |
centrally authorised medicines
ⓘ
medicinal products for human use ⓘ nationally authorised medicines ⓘ |
| containsProvision |
deferrals of paediatric studies
ⓘ
paediatric clinical trial transparency requirements ⓘ pharmacovigilance obligations for paediatric medicines ⓘ waivers from paediatric requirements ⓘ |
| dateAdopted | 2006-12-12 ⓘ |
| dateEnteredIntoForce | 2007-01-26 ⓘ |
| enteredIntoForceIn | all EU Member States ⓘ |
| establishes |
Paediatric Committee
ⓘ
Paediatric Investigation Plan requirement ⓘ paediatric use marketing authorisation ⓘ rewards and incentives for paediatric studies ⓘ |
| goal |
reduce off-label use of medicines in children
ⓘ
stimulate high-quality paediatric research in the EU ⓘ |
| hasAbbreviation | EU Paediatric Regulation ⓘ |
| implementedBy |
European Medicines Agency
ⓘ
national competent authorities of EU Member States ⓘ |
| jurisdiction | European Union ⓘ |
| languageOfOfficialText | all official EU languages ⓘ |
| legalBasis |
Treaty establishing the European Community
ⓘ
linked to:
Treaty of Rome
|
| monitoredBy |
European Medicines Agency Paediatric Committee
ⓘ
linked to:
Paediatric Committee
|
| officialName | Regulation (EC) No 1901/2006 ⓘ |
| providesIncentive |
data and market protection for paediatric use marketing authorisation
ⓘ
six-month extension of supplementary protection certificate ⓘ two-year extension of orphan market exclusivity ⓘ |
| regulates |
authorisation of medicines for paediatric use
ⓘ
paediatric development plans for medicines ⓘ |
| relatedTo |
Directive 2001/83/EC
ⓘ
Regulation (EC) No 726/2004 ⓘ |
| requires |
Paediatric Investigation Plan for new indications
ⓘ
linked to:
Paediatric Regulation
Paediatric Investigation Plan for new medicines ⓘ Paediatric Investigation Plan for new pharmaceutical forms ⓘ Paediatric Investigation Plan for new routes of administration ⓘ |
| sector |
pharmaceutical regulation
ⓘ
public health ⓘ |
| subjectOf | European Commission progress reports ⓘ |
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: Paediatric Regulation Description of subject: The Paediatric Regulation is a European Union law designed to improve the development and availability of medicines specifically adapted for use in children.
Referenced by (5)
Full triples — surface form annotated when it differs from this entity's canonical label.
linked to: Paediatric Regulation
linked to: Paediatric Regulation
subject linked to:
Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006