Pharmaceuticals and Medical Devices Agency Japan

E555156

government agency independent administrative institution regulatory agency

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.

Try in SPARQL Jump to: Surface forms Disambiguation Statements Elicitation Referenced by

All labels observed (5)

Label	Occurrences
Pharmaceuticals and Medical Devices Agency	2
Pharmaceuticals and Medical Devices Agency Japan canonical	2
Pharmaceuticals and Medical Devices Agency of Japan	2
Japanese Pharmaceuticals and Medical Devices Agency	1
医薬品医療機器総合機構	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.
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
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 ⓘ linked to: PMDA Japan
alsoKnownAs	PMDA Japan ⓘ
cooperatesWith	European Medicines Agency ⓘ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ Ministry of Health, Labour and Welfare ⓘ linked to: Ministry of Health, Labour and Welfare of Japan U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration World Health Organization ⓘ
country	Japan ⓘ
hasOfficialWebsite	https://www.pmda.go.jp ⓘ
headquartersLocation	Chiyoda, Tokyo, Japan ⓘ Tokyo, Japan ⓘ linked to: Tokyo
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 ⓘ linked to: Pharmaceuticals and Medical Devices Agency Japan
parentOrganization	Ministry of Health, Labour and Welfare ⓘ linked to: Ministry of Health, Labour and Welfare of Japan
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

Referenced by (8)

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 ⓘ

ICH M4 Common Technical Document → adoptedBy → Pharmaceuticals and Medical Devices Agency of Japan ⓘ