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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”〔(GHTF General Information )〕 whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members (the European Union, the United States, Canada, Japan and Australia) were divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices."〔(GHTF Homepage )〕 The GHTF disbanded late in 2012.〔(GHTF Says Final Goodbyes, Shutters Website )〕 Its mission has been taken over by the International Medical Device Regulators Forum (IMDRF), a successor organization composed of officials from regulatory agencies— not industry — around the world.〔(IMDRF website )〕 The GHTF website is no longer operational. ==Mission statement== As quoted from the GHTF site now (IMDRF), “The purpose of the GHTF is to encourage the convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by four different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF Founding Members.”〔(GHTF Summary Statement )〕 Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Global Harmonization Task Force」の詳細全文を読む スポンサード リンク
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