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Pharmaceuticals and Medical Devices Agency information


Pharmaceuticals and Medical Devices Agency
独立行政法人医薬品医療機器総合機構
Agency overview
FormedApril 1, 2004; 20 years ago (2004-04-01)
Employees873
Websitewww.pmda.go.jp
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The 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[1] 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 in the Philippines.[2]

The PhMDA has been eCTD compliant at least since December 2017.[3]

  1. ^ "Japan Medical Device Registration". Qualtech.
  2. ^ Nagasaka, Satoru. "An Overview of Pharmaceutical and Medical Device Regulation in Japan" (PDF). Morgan, Lewis & Bockius LLP. Archived from the original (PDF) on 11 February 2014. Retrieved 30 September 2012.
  3. ^ "ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide in Japan v1.2.0" (PDF). PhMDA. December 2017.

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by the FDA and the Japanese Pharmaceuticals and Medical Devices Agency allows a medical device to be marketed with several incentives and limited prove...

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regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals...

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products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by physical...

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Suvorexant

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Medicines Agency (EMA) that evaluates medicinal products. In Japan, the agency regulating medicinal products is Pharmaceuticals and Medical Devices Agency (PMDA)...

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Japanese Adverse Drug Event Report database

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system of drug adverse events which is managed by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It has been available since 2012. Pharmacovigilance...

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Alternative uses for placenta

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Machine Pharmaceuticals and Medical Devices Agency Japan Gleeson, Michael; Clarke, Ray (2008-04-25). Scott-Brown's Otorhinolaryngology: Head and Neck Surgery...

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Guidances for statistics in regulatory affairs

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industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved...

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Miriplatin

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chemoembolization (TACE). Miriplatin was approved by Japan's Pharmaceuticals and Medical Devices Agency in 2009. Oxaliplatin "Miriplatin". Inxight Drugs. National...

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Ripasudil

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potent and selective Rho-kinase inhibitory activity than fasudil". According to a report submitted to the Japanese Pharmaceuticals and Medical Devices Agency...

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Dotinurad

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"List of Approved Products" (PDF). Pharmaceuticals and Medical Devices Agency. "Fortress takes on dotinurad in USA and Europe". November 5, 2020. Retrieved...

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Isotopes of hydrogen

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Indisetron

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prophylaxis of chemotherapy-induced nausea and vomiting. It was approved by Japan's Pharmaceuticals and Medical Devices Agency in 2004. Indisetron exerts its effects...

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Meril Life Sciences

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transcatheter heart valve, Myval Octacor, upon approval by the Pharmaceuticals and Medical Devices Agency in Japan. It operates in more than 100 countries. It has...

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PMDA

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PMDA may refer to: Pharmaceuticals and Medical Devices Agency, a Japanese governmental organization, similar in function to the Food and Drug Administration...

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Nemonapride

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Medical device

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purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in...

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Regulatory affairs

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working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of...

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Modafinil

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