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Pharmaceuticals and Medical Devices Agency: Difference between revisions

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| employees = 873
| website = {{URL|http://www.pmda.go.jp/}}
| formed = April{{Start 1,date and age|2004|4|1|y=df}}
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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>
 
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>