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Drug and medical device testing: Scientific review of market authorization applications based on Japanese pharmaceutical law; Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA))
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 ...
Nipro Corporation (ニプロ株式会社, Nipro Kabushiki-gaisha) is a Japanese medical equipment manufacturing company. Founded in 1954, the company is headquartered in Osaka and is listed on the Tokyo Stock Exchange and the Osaka Securities Exchange.
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The Japan Agency for Medical Research and Development (AMED; Japanese: 日本医療研究開発機構), created in April 2015, is an independent Japanese medical research and development organization, [1] overseen by the Office of Healthcare Policy of Cabinet Secretariat, the Ministry of Education, Culture, Sports, Science and Technology (MEXT), the Ministry of Health, Labor and Welfare (MHLW ...
The probe will collect information from companies and member states and its primary aim is to enter into a dialogue with China to ensure that markets are fair and open, the report said. China and ...
EU investigates fair access to China's medical device market. Philip Blenkinsop and Ingrid Melander. April 24, 2024 at 10:05 AM. By Philip Blenkinsop and Ingrid Melander.