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{{Short description|Japanese Independent Administrative Institution}}
{{Infobox government agency
| name = Pharmaceuticals and Medical Devices Agency
| native_name_lang = [[Japanese language|Japanese]]
| width = 250px
| image = Pharmaceuticals and Medical Devices Agency.svg
| registration_id = 100-0013
| employees = 873
| website = {{URL|http://www.pmda.go.jp/}}
| formed = {{Start date and age|2004|4|1|y=df}}
|}}
The {{Nihongo|'''Pharmaceuticals and Medical Devices Agency'''|独立行政法人医薬品医療機器総合機構|Dokuritsu-gyōsei hōjin iyakuhin-iryō-kiki-sōgō-kikō}} ('''PhMDA''') is an [[Independent Administrative Institution]] responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices<ref>{{cite news | title = Japan Medical Device Registration | url = https://www.qualtechs.com/en-gb/japan_registration | publisher = Qualtech | language = en}}</ref> in [[Japan]]. It is similar in function to the [[Food and Drug Administration]] in the United States, the [[Medicines and Healthcare products Regulatory Agency]] in the United Kingdom, the [[Spanish Agency of Medicines and Medical Devices]] in Spain or the [[Food and Drug Administration (Philippines)|Food and Drug Administration]] in the Philippines.<ref>{{cite web|last=Nagasaka|first=Satoru|title=An Overview of Pharmaceutical and Medical Device Regulation in Japan|url=http://www.morganlewis.com/pubs/Overview_Pharma_device_reg.pdf|publisher=Morgan, Lewis & Bockius LLP|accessdate=30 September 2012|archive-url=https://web.archive.org/web/20140211214644/http://www.morganlewis.com/pubs/Overview_Pharma_device_reg.pdf|archive-date=11 February 2014|url-status=dead}}</ref>
== Tasks ==▼
The PhMDA has been [[eCTD]] compliant at least since December 2017.<ref>{{cite news |title=ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide in Japan v1.2.0 |url=https://www.pmda.go.jp/files/000222267.pdf |publisher=PhMDA |date=December 2017}}</ref>
▲== Tasks ==
Among other things, the agency is tasked with the following:
* Drug and medical device testing:
** Scientific review of market authorization applications based on Japanese pharmaceutical law
** Advice
** Inspection and conformity assessment of [[Good Clinical Practice]] (GCP), [[Good Laboratory Practice]] (GLP), and [[Good Practice Systems and Programs]] (GPSP)
** Auditing of manufacturers to ensure they conform to [[Good Manufacturing Practice]] (GMP) and have a suitable [[Quality Management System]] (QMS)
* Post-marketing drug safety:
** The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices
** Advising consumers on approved products
** Research on the development of industry standards
* Victim compensation:
** Payment of medical costs, lost wages, and pain and suffering for those who
** Disbursement of funds to those infected with [[HIV]] as a result of [[blood transfusion]]s
== Leadership ==
The chief executive of the agency is Yasuhiro Fujiwara, former head of the National Cancer Center Japan. From 2008 to 2018, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.
==References==
{{reflist}}
==External links==
[[Category:Health in Japan]]▼
* {{Official website|http://www.pmda.go.jp/}}
{{authority control}}
[[Category:Medical and health organizations based in Japan]]
[[Category:National agencies for drug regulation]]
▲[[ja:医薬品医療機器総合機構]]
[[Category:Independent Administrative Institutions of Japan]]
[[Category:Government agencies established in 2004]]
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