Federal Institute for Drugs and Medical Devices
E105569
The Federal Institute for Drugs and Medical Devices is Germany’s central regulatory authority responsible for the authorization, safety monitoring, and risk assessment of pharmaceuticals and medical devices.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Federal Institute for Drugs and Medical Devices canonical | 3 |
| Bundesinstitut für Arzneimittel und Medizinprodukte | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T861495 — 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: Federal Institute for Drugs and Medical Devices Context triple: [Federal Ministry of Health (Germany), oversees, Federal Institute for Drugs and Medical Devices]
-
A.
Paul Ehrlich Institute
The Paul Ehrlich Institute is Germany’s federal agency and research institution responsible for the evaluation, authorization, and monitoring of vaccines and biomedicines.
-
B.
Robert Koch Institute
The Robert Koch Institute is Germany’s national public health institute, renowned for its research in infectious diseases, epidemiology, and disease prevention.
-
C.
German Institute for Medical Documentation and Information
The German Institute for Medical Documentation and Information is a federal agency responsible for managing health data, medical information systems, and standards to support healthcare and health policy in Germany.
-
D.
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.
-
E.
Helmholtz Association
The Helmholtz Association is Germany’s largest scientific research organization, operating a network of national research centers that conduct long-term, large-scale research in areas such as energy, health, environment, and technology.
- 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: Federal Institute for Drugs and Medical Devices Target entity description: The Federal Institute for Drugs and Medical Devices is Germany’s central regulatory authority responsible for the authorization, safety monitoring, and risk assessment of pharmaceuticals and medical devices.
-
A.
Paul Ehrlich Institute
The Paul Ehrlich Institute is Germany’s federal agency and research institution responsible for the evaluation, authorization, and monitoring of vaccines and biomedicines.
-
B.
Robert Koch Institute
The Robert Koch Institute is Germany’s national public health institute, renowned for its research in infectious diseases, epidemiology, and disease prevention.
-
C.
German Institute for Medical Documentation and Information
The German Institute for Medical Documentation and Information is a federal agency responsible for managing health data, medical information systems, and standards to support healthcare and health policy in Germany.
-
D.
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.
-
E.
Helmholtz Association
The Helmholtz Association is Germany’s largest scientific research organization, operating a network of national research centers that conduct long-term, large-scale research in areas such as energy, health, environment, and technology.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
federal institute of Germany
ⓘ
government agency ⓘ regulatory authority ⓘ |
| abbreviation | BfArM ⓘ |
| cooperatesWith |
European Medicines Agency
ⓘ
Paul Ehrlich Institute ⓘ
surface form:
Paul-Ehrlich-Institut
World Health Organization ⓘ |
| country | Germany ⓘ |
| employerOf |
pharmacists
ⓘ
pharmacologists ⓘ physicians ⓘ regulatory experts ⓘ scientists ⓘ |
| fieldOfWork |
drug safety
ⓘ
medical device safety ⓘ pharmacology ⓘ public health ⓘ regulatory science ⓘ |
| hasWebsite | https://www.bfarm.de ⓘ |
| headquartersCountry | Germany ⓘ |
| headquartersLocation | Bonn ⓘ |
| jurisdiction | Germany ⓘ |
| languageOfWorkOrName | German ⓘ |
| legalForm | federal higher authority ⓘ |
| locatedInTimeZone |
Central European Summer Time
ⓘ
Central European Time ⓘ |
| nativeName |
Federal Institute for Drugs and Medical Devices
self-linksurface differs
ⓘ
surface form:
Bundesinstitut für Arzneimittel und Medizinprodukte
|
| parentOrganization | Federal Ministry of Health ⓘ |
| partOf | German public health system ⓘ |
| primaryRole |
authorization of pharmaceuticals
ⓘ
regulation of medical devices ⓘ risk assessment of medical devices ⓘ risk assessment of pharmaceuticals ⓘ safety monitoring of medical devices ⓘ safety monitoring of pharmaceuticals ⓘ |
| responsibleFor |
benefit-risk assessment of medicines
ⓘ
classification of medical devices ⓘ clinical trial authorization for medicinal products ⓘ marketing authorization of medicinal products ⓘ monitoring adverse drug reactions ⓘ monitoring incidents with medical devices ⓘ pharmacovigilance ⓘ regulation of certain psychotropic substances ⓘ regulation of narcotics for medical use ⓘ |
| sector |
medical device regulation
ⓘ
pharmaceutical regulation ⓘ |
| shortName | BfArM ⓘ |
| subordinateTo | Federal Ministry of Health ⓘ |
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: Federal Institute for Drugs and Medical Devices Description of subject: The Federal Institute for Drugs and Medical Devices is Germany’s central regulatory authority responsible for the authorization, safety monitoring, and risk assessment of pharmaceuticals and medical devices.
Referenced by (4)
Full triples — surface form annotated when it differs from this entity's canonical label.
subject surface form:
Federal Ministry of Health (Germany)
Federal Institute for Drugs and Medical Devices
→
nativeName
→
Federal Institute for Drugs and Medical Devices
self-linksurface differs
ⓘ
this entity surface form:
Bundesinstitut für Arzneimittel und Medizinprodukte