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FDA is “redoubling” harmonization efforts

This article was originally published in The Gold Sheet

Executive Summary

FDA is working on an exchange of letters with Japan; developing a Memorandum of Understanding with Switzerland; working on a MOU with Australia; and developing an exchange of letters as well as a mutual recognition agreement with the EU, reported Friedman at the June 23 Pharma Conference. In addition, FDA is working on a MOU with Canada, and developing a trilateral cooperation agreement with Canada and Mexico. As a result of these agreements with the EU in particular, Friedman reported that "we could potentially be doing less inspections in the EU in the next couple of years … and more inspections in the emerging economies of China and India." He added that "we are interested in harmonization. We are seeking membership in PIC/S for the reason that PIC/S has more members and more harmonized techniques than ICH
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