Pharmaceutical and Medical Devices Agency (Japan)
GPTKB entity
Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:government_agency
|
| gptkbp:abbreviation |
gptkb:PMDA
|
| gptkbp:collaboratesWith |
gptkb:World_Health_Organization_(WHO)
gptkb:European_Medicines_Agency_(EMA) gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use_(ICH) gptkb:US_Food_and_Drug_Administration_(FDA) |
| gptkbp:country |
gptkb:Japan
|
| gptkbp:director |
Yasuhiro Fujiwara
|
| gptkbp:employs |
inspectors
reviewers regulatory scientists medical device specialists pharmaceutical specialists pharmacovigilance officers |
| gptkbp:established |
2004
|
| gptkbp:headquarters_location |
gptkb:Tokyo
|
| https://www.w3.org/2000/01/rdf-schema#label |
Pharmaceutical and Medical Devices Agency (Japan)
|
| gptkbp:languageOfService |
Japanese
|
| gptkbp:member |
Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee
International Coalition of Medicines Regulatory Authorities (ICMRA) |
| gptkbp:officialWebsite |
https://www.pmda.go.jp/
|
| gptkbp:organization |
gptkb:government_agency
|
| gptkbp:oversees |
adverse event reporting
post-marketing surveillance drug recalls medical device recalls drug approval process medical device approval process safety alerts GCP inspections GMP inspections GLP inspections |
| gptkbp:parentOrganization |
gptkb:Ministry_of_Health,_Labour_and_Welfare_(Japan)
|
| gptkbp:publishes |
annual reports
review reports safety information drug approval lists guidelines for drug development guidelines for medical device development medical device approval lists |
| gptkbp:regulates |
clinical trials in Japan
medical device manufacturers in Japan pharmaceutical companies in Japan |
| gptkbp:responsible_for |
regulation of medical devices
drug safety clinical trial oversight regulation of pharmaceuticals pharmacovigilance regulation of regenerative medical products |
| gptkbp:bfsParent |
gptkb:Good_Clinical_Practice_Guidelines
|
| gptkbp:bfsLayer |
7
|