Pharmaceuticals and Medical Devices Agency Japan
E555156
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory authority responsible for the review, approval, and safety monitoring of pharmaceuticals and medical devices.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Pharmaceuticals and Medical Devices Agency Japan canonical | 1 |
| Pharmaceuticals and Medical Devices Agency of Japan | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5932482 — 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: Pharmaceuticals and Medical Devices Agency Japan Context triple: [ICH Q9 Quality Risk Management, regionallyImplementedBy, Pharmaceuticals and Medical Devices Agency Japan]
-
A.
Japanese Ministry of Health and Welfare
The Japanese Ministry of Health and Welfare was a former government ministry of Japan responsible for national public health policy, medical services, and social welfare programs before its functions were merged into the Ministry of Health, Labour and Welfare.
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B.
Management and Coordination Agency of Japan
The Management and Coordination Agency of Japan was a former central government body responsible for administrative management, coordination, and oversight functions before being integrated into the modern Ministry of Internal Affairs and Communications.
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C.
Japan Fair Trade Commission
The Japan Fair Trade Commission is Japan’s independent competition authority responsible for enforcing antitrust laws, promoting fair trade, and preventing monopolistic and unfair business practices.
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D.
Mitsubishi Tanabe Pharma
Mitsubishi Tanabe Pharma is a Japanese pharmaceutical company known for developing prescription drugs and biopharmaceuticals, including treatments for neurological and autoimmune diseases.
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E.
Science Council of Japan
The Science Council of Japan is a national organization that represents the Japanese scientific community and advises the government on science and technology policy.
- 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: Pharmaceuticals and Medical Devices Agency Japan Target entity description: The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory authority responsible for the review, approval, and safety monitoring of pharmaceuticals and medical devices.
-
A.
Japanese Ministry of Health and Welfare
The Japanese Ministry of Health and Welfare was a former government ministry of Japan responsible for national public health policy, medical services, and social welfare programs before its functions were merged into the Ministry of Health, Labour and Welfare.
-
B.
Management and Coordination Agency of Japan
The Management and Coordination Agency of Japan was a former central government body responsible for administrative management, coordination, and oversight functions before being integrated into the modern Ministry of Internal Affairs and Communications.
-
C.
Japan Fair Trade Commission
The Japan Fair Trade Commission is Japan’s independent competition authority responsible for enforcing antitrust laws, promoting fair trade, and preventing monopolistic and unfair business practices.
-
D.
Mitsubishi Tanabe Pharma
Mitsubishi Tanabe Pharma is a Japanese pharmaceutical company known for developing prescription drugs and biopharmaceuticals, including treatments for neurological and autoimmune diseases.
-
E.
Science Council of Japan
The Science Council of Japan is a national organization that represents the Japanese scientific community and advises the government on science and technology policy.
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
government agency
ⓘ
independent administrative institution ⓘ regulatory agency ⓘ |
| abbreviation | PMDA NERFINISHED ⓘ |
| alsoKnownAs | PMDA Japan NERFINISHED ⓘ |
| cooperatesWith |
European Medicines Agency
NERFINISHED
ⓘ
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ Ministry of Health, Labour and Welfare NERFINISHED ⓘ U.S. Food and Drug Administration NERFINISHED ⓘ World Health Organization NERFINISHED ⓘ |
| country | Japan ⓘ |
| hasOfficialWebsite | https://www.pmda.go.jp ⓘ |
| headquartersLocation |
Chiyoda, Tokyo, Japan
NERFINISHED
ⓘ
Tokyo, Japan NERFINISHED ⓘ |
| jurisdiction | Government of Japan ⓘ |
| languageOfWorkOrName | Japanese ⓘ |
| legalForm | independent administrative institution of Japan ⓘ |
| mandate |
ensure quality, efficacy, and safety of medical devices in Japan
ⓘ
ensure quality, efficacy, and safety of pharmaceuticals in Japan ⓘ |
| nativeName | 医薬品医療機器総合機構 NERFINISHED ⓘ |
| parentOrganization | Ministry of Health, Labour and Welfare NERFINISHED ⓘ |
| performs |
benefit-risk assessment of medical products
ⓘ
regulatory science research ⓘ risk management of medical products ⓘ |
| regionServed | Japan ⓘ |
| regulates |
biopharmaceuticals
ⓘ
in vitro diagnostic medical devices ⓘ over-the-counter drugs ⓘ prescription drugs ⓘ |
| responsibleFor |
GCP inspections
ⓘ
GLP inspections ⓘ GMP inspections ⓘ adverse drug reaction assessment ⓘ adverse event reporting system ⓘ drug safety monitoring ⓘ medical device regulation ⓘ medical device safety monitoring ⓘ pharmaceutical regulation ⓘ pharmacovigilance ⓘ post-marketing surveillance ⓘ regulation of cellular and gene therapy products ⓘ regulation of regenerative medical products ⓘ review of clinical trial notifications ⓘ review of generic drug applications ⓘ review of medical device applications ⓘ review of new drug applications ⓘ |
| sector |
healthcare regulation
ⓘ
medical device regulation ⓘ pharmaceutical regulation ⓘ |
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: Pharmaceuticals and Medical Devices Agency Japan Description of subject: The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory authority responsible for the review, approval, and safety monitoring of pharmaceuticals and medical devices.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
ICH Q9 Quality Risk Management
→
regionallyImplementedBy
→
Pharmaceuticals and Medical Devices Agency Japan
ⓘ
this entity surface form:
Pharmaceuticals and Medical Devices Agency of Japan