Pharmaceuticals and Medical Devices Agency
GPTKB entity
Statements (62)
| 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:employs |
gptkb:engineer
pharmacists administrative staff inspectors medical officers reviewers regulatory scientists |
| gptkbp:established |
2004
|
| gptkbp:headquarters_location |
gptkb:Tokyo
|
| https://www.w3.org/2000/01/rdf-schema#label |
Pharmaceuticals and Medical Devices Agency
|
| gptkbp:jurisdiction |
gptkb:Japan
|
| gptkbp:languageOfService |
Japanese
|
| gptkbp:officialWebsite |
https://www.pmda.go.jp/
|
| gptkbp:organization |
gptkb:government_agency
|
| gptkbp:oversees |
gptkb:Japanese_Pharmacopoeia
adverse event reporting product recalls pharmacovigilance orphan drug designation accelerated approval system conditional approval system drug master files medical device master files post-marketing studies priority review system re-evaluation system re-examination system risk management plans |
| gptkbp:parentOrganization |
gptkb:Ministry_of_Health,_Labour_and_Welfare_(Japan)
|
| gptkbp:provides |
guidance documents
consultation services training programs public information inspection reports drug information review reports safety alerts medical device information regulatory science research |
| gptkbp:regulates |
clinical trials
pharmaceutical manufacturing medical device manufacturing drug approval medical device approval regenerative medicine approval |
| gptkbp:responsible_for |
regulation of medical devices
post-marketing surveillance drug safety regulation of pharmaceuticals GCP inspections GMP inspections regulation of regenerative medical products |
| gptkbp:bfsParent |
gptkb:Ministry_of_Health,_Labour_and_Welfare_(Japan)
gptkb:Ministry_of_Health,_Labour_and_Welfare |
| gptkbp:bfsLayer |
5
|