Japanese Pharmaceuticals and Medical Devices Agency
GPTKB entity
Statements (65)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
government agency
|
| gptkbp:collaborates_with |
international regulatory agencies
|
| gptkbp:conducts |
public consultations
risk assessments post-marketing surveillance research on medical devices research on pharmaceuticals |
| gptkbp:country |
gptkb:Japan
|
| gptkbp:develops |
regulatory frameworks
|
| gptkbp:established |
2004
|
| gptkbp:has_a_role_in |
public health
public health campaigns patient safety initiatives health technology assessment healthcare_policy drug safety monitoring drug approval timelines drug pricing policy device approval timelines device market access device safety monitoring drug market access medical device pricing policy |
| gptkbp:has_a_website |
www.pmda.go.jp
|
| gptkbp:headquarters |
gptkb:Tokyo
|
| https://www.w3.org/2000/01/rdf-schema#label |
Japanese Pharmaceuticals and Medical Devices Agency
|
| gptkbp:is_a_member_of |
gptkb:International_Council_for_Harmonisation
gptkb:Asian_Harmonization_Working_Party |
| gptkbp:is_involved_in |
regulatory compliance
regulatory science |
| gptkbp:issues |
annual reports
recalls for unsafe products safety alerts guidelines for drug development guidelines for pharmacovigilance guidelines for ethical review of clinical trials guidelines for medical device development guidelines for post-market studies guidelines for risk management plans |
| gptkbp:monitors |
adverse drug reactions
adverse device events |
| gptkbp:participatesIn |
international conferences
|
| gptkbp:promotes |
safety of medical devices
safety of pharmaceuticals |
| gptkbp:provides |
consultation services
training for healthcare professionals technical advice guidelines for clinical trials information on clinical trials information on drug safety information on regulatory processes public access to drug information support for clinical research information on medical device safety public access to device information support for regulatory submissions |
| gptkbp:regulates |
medical devices
pharmaceuticals |
| gptkbp:reportsTo |
gptkb:Ministry_of_Health,_Labour_and_Welfare
|
| gptkbp:responsibleFor |
approval of drugs
approval of medical devices |
| gptkbp:supports |
innovation in medical devices
innovation in pharmaceuticals |
| gptkbp:works_with |
academic institutions
industry stakeholders |