Regulation (EC) No 1901/2006
E563353
Regulation (EC) No 1901/2006 is the European Union’s Paediatric Regulation, establishing rules to ensure that medicines for children are researched, developed, and authorized to the same high standards as those for adults.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EC) No 1901/2006 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5873304 — 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: Regulation (EC) No 1901/2006 Context triple: [Paediatric Regulation, officialName, Regulation (EC) No 1901/2006]
-
A.
Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
-
B.
Regulation (EC) No 294/2008
Regulation (EC) No 294/2008 is the EU legislative act that established the European Institute of Innovation and Technology and set out its mission, structure, and operating framework.
-
C.
Regulation (EC) No 851/2004
Regulation (EC) No 851/2004 is the EU law that established the European Centre for Disease Prevention and Control and defined its mandate, structure, and functions in coordinating infectious disease surveillance and control across member states.
-
D.
Regulation (EC) No 141/2000
Regulation (EC) No 141/2000 is the European Union’s core legal framework establishing incentives and procedures for the designation, development, and authorization of orphan medicinal products for rare diseases.
-
E.
Regulation (EC) No 45/2001
Regulation (EC) No 45/2001 is an EU law that sets out data protection rules for the processing of personal data by EU institutions and bodies.
- 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: Regulation (EC) No 1901/2006 Target entity description: Regulation (EC) No 1901/2006 is the European Union’s Paediatric Regulation, establishing rules to ensure that medicines for children are researched, developed, and authorized to the same high standards as those for adults.
-
A.
Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
-
B.
Regulation (EC) No 294/2008
Regulation (EC) No 294/2008 is the EU legislative act that established the European Institute of Innovation and Technology and set out its mission, structure, and operating framework.
-
C.
Regulation (EC) No 851/2004
Regulation (EC) No 851/2004 is the EU law that established the European Centre for Disease Prevention and Control and defined its mandate, structure, and functions in coordinating infectious disease surveillance and control across member states.
-
D.
Regulation (EC) No 141/2000
Regulation (EC) No 141/2000 is the European Union’s core legal framework establishing incentives and procedures for the designation, development, and authorization of orphan medicinal products for rare diseases.
-
E.
Regulation (EC) No 45/2001
Regulation (EC) No 45/2001 is an EU law that sets out data protection rules for the processing of personal data by EU institutions and bodies.
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
EU paediatric regulation
ⓘ
European Union regulation ⓘ |
| abbreviation | PUMA for paediatric use marketing authorisation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| adoptionDate | 2006-12-12 ⓘ |
| aimsToPrevent |
delays in authorisation of medicines for adults
ⓘ
unnecessary clinical trials in children ⓘ |
| amends |
Directive 2001/83/EC
NERFINISHED
ⓘ
Regulation (EEC) No 1768/92 NERFINISHED ⓘ |
| appliesTo |
medicinal products for human use
ⓘ
paediatric population ⓘ |
| contains |
requirements for labelling and package information for paediatric medicines
ⓘ
requirements for paediatric clinical trials ⓘ requirements for pharmacovigilance in paediatric use ⓘ |
| definesTerm | paediatric population ⓘ |
| entryIntoForceDate | 2007-01-26 ⓘ |
| establishesBody | Paediatric Committee NERFINISHED ⓘ |
| geographicalScope | all EU Member States ⓘ |
| introducesInstrument | paediatric investigation plan ⓘ |
| jurisdiction | European Union ⓘ |
| languageOfTitle | all official EU languages ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| legalNature | directly applicable in all EU Member States ⓘ |
| mainObjective | to improve the health of children in the European Union ⓘ |
| monitoredBy |
European Medicines Agency
NERFINISHED
ⓘ
national competent authorities of Member States ⓘ |
| objective |
to ensure that medicines for children are appropriately authorised
ⓘ
to ensure that medicines used to treat children are subject to high quality research ⓘ to improve information on medicines for children ⓘ |
| officialName | Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use NERFINISHED ⓘ |
| OJIssuesNumber | 378 ⓘ |
| OJPublicationDate | 2006-12-27 ⓘ |
| OJSeries | L ⓘ |
| PaediatricCommitteeAbbreviation | PDCO NERFINISHED ⓘ |
| PaediatricCommitteeHostedBy | European Medicines Agency NERFINISHED ⓘ |
| paediatricPopulationAgeRange | 0 to 18 years ⓘ |
| policyArea |
pharmaceuticals
ⓘ
public health ⓘ |
| providesIncentive |
paediatric use marketing authorisation
ⓘ
six-month extension of the supplementary protection certificate ⓘ two-year extension of orphan market exclusivity ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| relatedTo |
clinical trials in children
ⓘ
orphan medicinal products ⓘ |
| requires | paediatric investigation plan for most new marketing authorisation applications ⓘ |
| requiresComplianceFrom | pharmaceutical companies ⓘ |
| shortName | Paediatric Regulation NERFINISHED ⓘ |
| subjectToEvaluation | European Commission reviews ⓘ |
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: Regulation (EC) No 1901/2006 Description of subject: Regulation (EC) No 1901/2006 is the European Union’s Paediatric Regulation, establishing rules to ensure that medicines for children are researched, developed, and authorized to the same high standards as those for adults.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.