Regulation (EC) No 1394/2007
E559101
Regulation (EC) No 1394/2007 is the core EU legal framework governing advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies, setting specific rules for their authorization, supervision, and pharmacovigilance.
All labels observed (2)
How this entity was disambiguated
This entity first appeared as the object of triple T5872822 — 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 1394/2007 Context triple: [European Union pharmaceutical legislation, includes, Regulation (EC) No 1394/2007]
-
A.
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.
-
B.
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.
-
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 (EU) No 1094/2010
Regulation (EU) No 1094/2010 is an EU legislative act that established the European Insurance and Occupational Pensions Authority (EIOPA) and set out its powers and supervisory framework for insurance and pension markets in the European Union.
-
E.
Regulation (EU) No 1093/2010
Regulation (EU) No 1093/2010 is the EU legislative act that established the European Banking Authority and set out its mandate, powers, and governance framework for overseeing the banking sector.
- 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 1394/2007 Target entity description: Regulation (EC) No 1394/2007 is the core EU legal framework governing advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies, setting specific rules for their authorization, supervision, and pharmacovigilance.
-
A.
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.
-
B.
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.
-
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 (EU) No 1094/2010
Regulation (EU) No 1094/2010 is an EU legislative act that established the European Insurance and Occupational Pensions Authority (EIOPA) and set out its powers and supervisory framework for insurance and pension markets in the European Union.
-
E.
Regulation (EU) No 1093/2010
Regulation (EU) No 1093/2010 is the EU legislative act that established the European Banking Authority and set out its mandate, powers, and governance framework for overseeing the banking sector.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
pharmaceutical law ⓘ |
| adoptedBy |
Council of the European Union
ⓘ
European Parliament ⓘ |
| amends |
Directive 2001/83/EC
ⓘ
Regulation (EC) No 726/2004 ⓘ |
| appliesTo |
advanced therapy medicinal products
ⓘ
combined advanced therapy medicinal products ⓘ gene therapy medicinal products ⓘ somatic cell therapy medicinal products ⓘ tissue engineered products ⓘ |
| assignsRoleTo |
Committee for Advanced Therapies
ⓘ
European Medicines Agency ⓘ |
| basedOn | Article 95 of the EC Treaty ⓘ |
| complements |
Directive 2001/83/EC on the Community code relating to medicinal products for human use
ⓘ
Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products ⓘ
linked to:
Regulation (EC) No 726/2004
|
| containsDefinitionOf |
advanced therapy medicinal product
ⓘ
combined advanced therapy medicinal product ⓘ gene therapy medicinal product ⓘ somatic cell therapy medicinal product ⓘ tissue engineered product ⓘ |
| coreFrameworkFor | EU regulation of advanced therapy medicinal products ⓘ |
| establishes |
a centralized marketing authorization procedure for advanced therapy medicinal products
ⓘ
requirements for quality, safety and efficacy of advanced therapy medicinal products ⓘ specific rules for advanced therapy medicinal products ⓘ the Committee for Advanced Therapies ⓘ
linked to:
Committee for Advanced Therapies
|
| jurisdiction | European Union ⓘ |
| language |
English
ⓘ
all official languages of the European Union ⓘ |
| legalArea |
health law
ⓘ
medicinal products regulation ⓘ pharmaceutical regulation ⓘ |
| objective |
to ensure a high level of health protection for patients using advanced therapy medicinal products
ⓘ
to facilitate the internal market for advanced therapy medicinal products ⓘ to foster innovation in gene, cell and tissue‑engineered therapies ⓘ |
| officialName |
Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products
ⓘ
linked to:
Regulation (EC) No 1394/2007
|
| regulates |
authorization of advanced therapy medicinal products
ⓘ
hospital exemption for certain advanced therapy medicinal products ⓘ labelling and package leaflet of advanced therapy medicinal products ⓘ pharmacovigilance of advanced therapy medicinal products ⓘ post‑authorization safety monitoring of advanced therapy medicinal products ⓘ risk management systems for advanced therapy medicinal products ⓘ supervision of advanced therapy medicinal products ⓘ traceability requirements for advanced therapy medicinal products ⓘ |
| requires | centralized evaluation of advanced therapy medicinal products by the European Medicines Agency ⓘ |
| scope |
advanced therapy medicinal products intended to be placed on the market in Member States
ⓘ
industrial‑scale manufacture of advanced therapy medicinal products ⓘ |
| subjectOf | European Union pharmaceutical legislation ⓘ |
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 1394/2007 Description of subject: Regulation (EC) No 1394/2007 is the core EU legal framework governing advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies, setting specific rules for their authorization, supervision, and pharmacovigilance.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
Regulation (EC) No 1394/2007
→
officialName
→
Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products
ⓘ
linked to: Regulation (EC) No 1394/2007