PMDA (Pharmaceuticals and Medical Devices Agency) Japan
GPTKB entity
Statements (55)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:government_agency
|
| gptkbp:bfsLayer |
6
|
| gptkbp:bfsParent |
gptkb:ISO_14971-1
|
| gptkbp:aims_to |
protect public health
ensure safety promote innovation ensure efficacy |
| gptkbp:collaborates_with |
gptkb:FDA
gptkb:WHO gptkb:EMA |
| gptkbp:conducts |
assessments
inspections evaluations |
| gptkbp:country |
gptkb:Japan
|
| gptkbp:established |
gptkb:2004
|
| gptkbp:focus |
gptkb:hospital
gptkb:drug |
| gptkbp:has_authority_over |
medical device safety
drug safety |
| gptkbp:has_role |
drug development
medical device regulation medical device development pharmaceutical regulation |
| gptkbp:headquarters |
gptkb:Tokyo
|
| https://www.w3.org/2000/01/rdf-schema#label |
PMDA (Pharmaceuticals and Medical Devices Agency) Japan
|
| gptkbp:is_involved_in |
gptkb:international_collaboration
gptkb:Research_Institute public health initiatives regulatory harmonization |
| gptkbp:issues |
guidelines for clinical trials
guidelines for drug approval guidelines for medical devices |
| gptkbp:parent_company |
gptkb:Ministry_of_Health,_Labour_and_Welfare
|
| gptkbp:provides |
gptkb:municipality
technical advice regulatory science research |
| gptkbp:publishes |
gptkb:municipality
annual reports safety information |
| gptkbp:regulates |
clinical trials
vaccines biologics |
| gptkbp:responsible_for |
safety monitoring
drug evaluation medical device evaluation |
| gptkbp:role |
gptkb:municipality
|
| gptkbp:services |
safety information
drug approval post-marketing surveillance medical device approval clinical trial consultation |
| gptkbp:supports |
research and development
regulatory compliance market access |
| gptkbp:website |
www.pmda.go.jp
|