PMDA Japan

E821690

PMDA Japan is Japan’s national regulatory authority responsible for evaluating and overseeing the safety, efficacy, and quality of pharmaceuticals and medical devices.

All labels observed (1)

Label Occurrences
PMDA Japan canonical 1

How this entity was disambiguated

Statements (45)

Predicate Object
instanceOf government agency
pharmaceutical regulatory agency
regulatory authority
abbreviation PMDA NERFINISHED
collaboratesWith Ministry of Health, Labour and Welfare of Japan NERFINISHED
country Japan
hasRole providing relief services for adverse drug reactions
providing relief services for infections caused by biological products
regulatory science promotion
risk management of medical products
headquartersLocation Japan
Tokyo
jurisdiction Japan
memberOf International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED
International Medical Device Regulators Forum NERFINISHED
officialName Pharmaceuticals and Medical Devices Agency NERFINISHED
oversees efficacy of medical devices
efficacy of pharmaceuticals
quality of medical devices
quality of pharmaceuticals
safety of medical devices
safety of pharmaceuticals
regulates biologics
in vitro diagnostics
medical devices
over-the-counter drugs
prescription drugs
regenerative medicine products
vaccines
responsibleFor GCP inspection
GLP inspection
GMP inspection
clinical trial review
drug safety evaluation
marketing authorization review
medical device regulation
medical device safety monitoring
pharmaceutical regulation
pharmacovigilance
post-marketing safety surveillance
regulation of regenerative medical products
sector healthcare regulation
public health
worksWith European Medicines Agency NERFINISHED
U.S. Food and Drug Administration NERFINISHED

How these facts were elicited

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.