FDA Global Offices Update: China Approval Imminent, India On The Horizon
This article was originally published in The Gray Sheet
Executive Summary
FDA is making headway in its efforts to establish U.S. regulatory offices overseas, with final approval in China imminent and a proposal for offices in India in final stages of U.S. approval
You may also be interested in...
FDA hits Latin America
FDA opens an office in Costa Rica Jan. 7 as part of an initiative to improve import safety by enhancing its presence in source countries. The office is intended to be the first of a series in the region. FDA opened its first facilities in China, in the cities of Beijing, Shanghai and Guangzhou, in November; and it also recently opened a new office in Brussels. Locations in India and the Middle East also are planned (1"The Gray Sheet" June 23, 2008, p. 5)
FDA hits Latin America
FDA opens an office in Costa Rica Jan. 7 as part of an initiative to improve import safety by enhancing its presence in source countries. The office is intended to be the first of a series in the region. FDA opened its first facilities in China, in the cities of Beijing, Shanghai and Guangzhou, in November; and it also recently opened a new office in Brussels. Locations in India and the Middle East also are planned (1"The Gray Sheet" June 23, 2008, p. 5)
FDA opens first offices in China
U.S. agency opens offices in Beijing, Guangzhou and Shanghai, China, the week of Nov. 17 in a move approved by the U.S. State Department in March (1"The Gray Sheet" June 23, 2008, p. 5). The eight senior staffers selected to work there are inspectors and senior technical experts in foods, medicines and medical devices, HHS notes. "By having a presence in other parts of the world, we can work more closely with manufacturers and other governments, better share best practices and further ensure ... quality and safety," stated HHS Secretary Mike Leavitt, who along with FDA Commissioner Andrew von Eschenbach traveled to the three cities last week to meet with manufacturers and Chinese government officials to discuss policy and governance reforms aimed at improving the safety of food and medical products. HHS also is working to have an FDA presence in India, Europe, Latin America and the Middle East