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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 collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices; Advising consumers on approved products; Research on the development of industry standards; Victim compensation: Payment of medical costs, lost wages, and pain and suffering for those who experience injury or disability ...
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
Division of application is not allowed after the applicant received a copy of the examiner's decision to grant a patent. The Japan Patent Office's interpretation of the patent law related to examination procedure is provided for in the "Examination Guidelines for Patent and Utility Model in Japan" in English." [12]
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
Takeda Pharmaceutical Company Limited (NYSE:TAK) announced on Friday that the Japanese Ministry of Health, Labour and Welfare has approved HYQVIA (Immune Globulin Infusion 10% with Recombinant ...
Entrance to the Japan Patent Office. The Japan Patent Office (特許庁, Tokkyochō, JPO) is a Japanese governmental agency in charge of industrial property right affairs, under the Ministry of Economy, Trade and Industry. The Japan Patent Office is located in Kasumigaseki, Chiyoda, Tokyo and is one of the world's largest patent offices.