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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.
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]
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 ...
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]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
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 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]