Tuesday, November 5, 2013

China Has Still Not Issued FDA Visas To Boost Inspection Staff Posted Tue, 11/05/2013 - 6:36am by Ed Silverman


For the past year, the FDA has been frustrated over an inability to obtain visas from China for its staffers to work on a long-term basis in the country. And the protracted delay has prevented the agency from proceeding with plans to increase inspections, bolster regulatory practices and collaborate with Chinese authorities on public health strategies.
The US State Department, you may recall, formally notified the Chinese Ministry of Foreign Affairs last fall about obtaining visas for additional inspectors, a move made possible by an extra $10 million in FDA funding. But since January, the agency has waited for visas and the agency publicly acknowledged frustration this past summer at the lack of progress.
So what has happened since then? Not much.
An FDA spokesman tells us the agency is working with the State Department and both agencies have “engaged” China’s Ministry of Foreign Affairs about the “importance of posting more FDA staff to China.” To date, the FDA believes the ministry has “undertaken an extensive, government-wide process to review FDA’s plans. While this process has taken longer than FDA had hoped, we trust that our two governments will soon be able to come to final agreement on this issue.”
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