Regulation (EU) No 536/2014
E553848
Regulation (EU) No 536/2014 is the European Union’s main legal framework governing the conduct, authorization, and oversight of clinical trials on medicinal products for human use.
All labels observed (2)
How this entity was disambiguated
This entity first appeared as the object of triple T5872819 — 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 (EU) No 536/2014 Context triple: [European Union pharmaceutical legislation, includes, Regulation (EU) No 536/2014]
-
A.
Regulation (EU) 1292/2013
Regulation (EU) 1292/2013 is an EU legislative act that sets out the framework, objectives, and operational rules for the European Institute of Innovation and Technology and its activities.
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B.
Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is a European Union law that establishes the quality schemes and protection framework for agricultural products and foodstuffs, including designations such as Protected Designation of Origin and Protected Geographical Indication.
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C.
Regulation (EU) No 1288/2013
Regulation (EU) No 1288/2013 is the European Union law that established and governs the Erasmus+ programme for education, training, youth and sport for the 2014–2020 period.
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D.
Regulation (EU) No 1025/2012
Regulation (EU) No 1025/2012 is an EU legal framework that governs European standardization activities, defining how standards are developed, adopted, and used to support EU policies and the internal market.
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E.
Regulation (EU) No 1095/2010
Regulation (EU) No 1095/2010 is the EU law that established the European Securities and Markets Authority (ESMA) and set out its powers and governance framework for overseeing securities markets and enhancing financial supervision in the European Union.
- 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 (EU) No 536/2014 Target entity description: Regulation (EU) No 536/2014 is the European Union’s main legal framework governing the conduct, authorization, and oversight of clinical trials on medicinal products for human use.
-
A.
Regulation (EU) 1292/2013
Regulation (EU) 1292/2013 is an EU legislative act that sets out the framework, objectives, and operational rules for the European Institute of Innovation and Technology and its activities.
-
B.
Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is a European Union law that establishes the quality schemes and protection framework for agricultural products and foodstuffs, including designations such as Protected Designation of Origin and Protected Geographical Indication.
-
C.
Regulation (EU) No 1288/2013
Regulation (EU) No 1288/2013 is the European Union law that established and governs the Erasmus+ programme for education, training, youth and sport for the 2014–2020 period.
-
D.
Regulation (EU) No 1025/2012
Regulation (EU) No 1025/2012 is an EU legal framework that governs European standardization activities, defining how standards are developed, adopted, and used to support EU policies and the internal market.
-
E.
Regulation (EU) No 1095/2010
Regulation (EU) No 1095/2010 is the EU law that established the European Securities and Markets Authority (ESMA) and set out its powers and governance framework for overseeing securities markets and enhancing financial supervision in the European Union.
- F. None of above. chosen
Statements (51)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
clinical trials regulation ⓘ |
| abbreviation | CTIS ⓘ |
| adoptedBy |
Council of the European Union
ⓘ
European Parliament ⓘ |
| adoptionDate | 2014-04-16 ⓘ |
| aimsTo |
ensure the reliability and robustness of clinical trial data
ⓘ
harmonise rules on clinical trials across EU Member States ⓘ increase transparency of clinical trial information ⓘ protect the rights, safety and well-being of clinical trial subjects ⓘ simplify and streamline clinical trial authorisation procedures ⓘ |
| applicableFrom | 2022-01-31 ⓘ |
| appliesIn | all EU Member States ⓘ |
| appliesTo |
clinical trials conducted in the European Union
ⓘ
medicinal products for human use ⓘ |
| contains |
rules on clinical trials in emergency situations
ⓘ
rules on clinical trials involving incapacitated subjects ⓘ rules on clinical trials involving minors ⓘ rules on inspection of clinical trials ⓘ rules on labelling of investigational medicinal products ⓘ rules on low-intervention clinical trials ⓘ rules on manufacturing and import of investigational medicinal products ⓘ rules on safety reporting and pharmacovigilance in clinical trials ⓘ |
| directlyApplicable | yes ⓘ |
| enteredIntoForceDate | 2014-06-16 ⓘ |
| establishes |
EU database for clinical trials
ⓘ
EU portal for clinical trial applications ⓘ |
| fullName |
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use
ⓘ
linked to:
Regulation (EU) No 536/2014
|
| implementedThrough | Clinical Trials Information System ⓘ |
| introduces |
coordinated assessment procedure between Member States
ⓘ
risk-based approach to clinical trial oversight ⓘ |
| legalBasis | Treaty on the Functioning of the European Union ⓘ |
| number | 536/2014 ⓘ |
| OJReference | OJ L 158, 27.5.2014, p. 1–76 ⓘ |
| policyArea |
clinical research
ⓘ
pharmaceuticals ⓘ public health ⓘ |
| publicationDate | 2014-05-27 ⓘ |
| publishedIn | Official Journal of the European Union ⓘ |
| relevantAuthority |
European Medicines Agency
ⓘ
national competent authorities of Member States ⓘ |
| repeals | Directive 2001/20/EC ⓘ |
| requires |
ethics committee involvement in clinical trial assessment
ⓘ
informed consent of clinical trial subjects ⓘ publication of clinical trial information in a public database ⓘ safety reporting of serious adverse events ⓘ single EU-wide clinical trial application per trial ⓘ submission of summary of clinical trial results ⓘ |
| shortName |
CTR
ⓘ
EU Clinical Trials Regulation ⓘ
linked to:
EU regulations
|
| subjectMatter | clinical trials on medicinal products for human use ⓘ |
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 (EU) No 536/2014 Description of subject: Regulation (EU) No 536/2014 is the European Union’s main legal framework governing the conduct, authorization, and oversight of clinical trials on medicinal products for human use.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
Regulation (EU) No 536/2014
→
fullName
→
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use
ⓘ
linked to: Regulation (EU) No 536/2014