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Japan on the Move: Pharmaceuticals and Medical …
https://www.gtlaw.com/en/insights/2021/10/japan-on-the-move-pharmaceuticals-medical-devices-pmd-act-amendment-compliance-japan
WEBOct 12, 2021 · The Amendment to the Act on Securing the Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices is the most comprehensive regulatory scheme reform for pharmaceuticals in past decade; Organizational …
DA: 28 PA: 63 MOZ Rank: 1
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Pharmaceuticals and Medical Devices Agency - PMDA
https://www.pmda.go.jp/english/
WEBClinical trials, reviews, consultations, compliance assessments, and inspections concerning applications for drugs, medical devices, regenerative medical products, etc. Post …
DA: 89 PA: 85 MOZ Rank: 14
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Japan on the Move: Pharmaceuticals and Medical …
https://www.natlawreview.com/article/japan-move-pharmaceuticals-and-medical-devices-pmd-act-amendment-demands-proper
WEBOct 12, 2021 · The Amendment to the Act on Securing the Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices is the most comprehensive …
DA: 46 PA: 37 MOZ Rank: 95
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Frequently Asked Questions (FAQ) | Pharmaceuticals …
https://www.pmda.go.jp/english/about-pmda/0004.html
Pharmaceuticals and Medical Devices AgencyApplication For Product ApprovalReviewsMaster File SystemAccreditation of Foreign ManufacturersInformation For Approved ProductsGmp/QmsPost-Marketing SafetyClinical TrialsMedical Advice Q1-1 What does PMDA do?PMDA is the regulatory agency which reviews quality, safety and efficacy of medical products to be marketed in Japan from scientific aspect. Please note that we do not provide the service to introduce/intermediate any company/organizations in Japan. For more information: Outline of P… Q1-2 May I use contents published on the PMDA website?It is allowed to use contents of the PMDA’s website freely without any advance notice to PMDA as described in the “Website Policies” page unless otherwise specified. Please make sure to confirm the website policies before using the contents of PMDA’s website.
Q1-1 What does PMDA do?PMDA is the regulatory agency which reviews quality, safety and efficacy of medical products to be marketed in Japan from scientific aspect. Please note that we do not provide the service to introduce/intermediate any company/organizations in Japan. For more information: Outline of P…
Q1-2 May I use contents published on the PMDA website?It is allowed to use contents of the PMDA’s website freely without any advance notice to PMDA as described in the “Website Policies” page unless otherwise specified. Please make sure to confirm the website policies before using the contents of PMDA’s website.
DA: 50 PA: 19 MOZ Rank: 84
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Ministry of Health, Labour and Welfare: Pharmaceuticals …
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html
WEBIn Japan, drugs and medical devices can be designated as orphan drugs or medical devices based on the Article 77-2 ( PDF :87KB) of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical …
DA: 19 PA: 98 MOZ Rank: 47
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Act on Pharmaceuticals and Medical Devices (PMD Act)
https://www.jqa.jp/english/safety/service/mandatory/pharmaceutical/
WEB9 rows · Act on Pharmaceuticals and Medical Devices (PMD Act) Medical device certification under the PMD Act *1 is a third-party certification of applicable medical …
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Latest Trend of Pharmaceutical and Medical Device …
https://www.pmda.go.jp/files/000236925.pdf
WEBPharmaceuticals and Medical Devices Act (PMD Act)*: the regulation of medical products in Japan. ‐ Mandatory review of the Act after the 5‐years implementation (PMD …
DA: 29 PA: 18 MOZ Rank: 2
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Act on Securing Quality, Efficacy and Safety of Products …
https://en.wikipedia.org/wiki/Act_on_Securing_Quality,_Efficacy_and_Safety_of_Products_Including_Pharmaceuticals_and_Medical_Devices
WEBAct on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法 …
DA: 34 PA: 2 MOZ Rank: 93