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.

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Observed surface forms (2)

Surface form	Occurrences
Pharmaceuticals and Medical Devices Agency of Japan	1
Pharmaceuticals and Medical Devices Agency	0

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 ⓘ

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 ⓘ

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

this entity surface form: Pharmaceuticals and Medical Devices Agency of Japan