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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 ...
The Japanese Adverse Drug Event Report (JADER) database is a spontaneous reporting system of drug adverse events which is managed by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. [1] It has been available since 2012. [1]
Sakigake (さきがけ, lit. "pathfinder", "harbinger") is a drug designation by the Pharmaceuticals and Medical Devices Agency, the pharmaceuticals regulator of Japan.It was designed to provide easier access to novel advanced treatments. [1]
This article needs to be updated.The reason given is: there was a significant revision to Japan's Pharmaceuticals and Medical Devices Act (PMD Act) in December 4, 2019 (令和 元 年12月 4日) and certain articles in this revised PMD Act took effect April 1, 2020, September 1, 2020, and August 1, 2021; other articles will take effect Dec. 1, 2022 (see also: https://www.natlawreview.com ...
The International Council for Harmonisation is a global organization with members from the European Union, the United States and Japan; its goal is to recommend global standards for drug companies and drug regulatory authorities around the world, with its activities overseen by the Steering Committee overseeing harmonization activities. [21]
PMDA may refer to: Pharmaceuticals and Medical Devices Agency , a Japanese governmental organization, similar in function to the Food and Drug Administration (FDA) in the US Plutonium Management and Disposition Agreement , an agreement between the United States and Russia signed in 2000
The Japanese Pharmacopoeia (Japanese: 日本薬局方, Hepburn: Nihon Yakkyokuhō) is the official pharmacopoeia of Japan.It is published by the Pharmaceuticals and ...
The first Western compounding pharmacy was opened in Japan in 1872 by Arinobu Fukuhara operating under the name Shiseidō. 1893 Japan Pharmaceutical Association was established as the sole national professional association for pharmacists. [4] [2] In 1909, The Japan Pharmaceutical Association was legally incorporated as a public interest ...