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Appendix H: Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration
Pages 345-348

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From page 345...
... A very large percentage of source countries represent developing economies with varying levels of regulatory oversight. Thus, we have a strong national interest in making sure that the countries of origin of these products have regulatory systems that apply, utilize, and enforce standards that support product safety comparable to that in the United States.
From page 346...
... In the case of medical products, drug falsification is growing in complexity, scale, geographic scope, and negative public health impact. Data limitations prevent public health policy makers from addressing adequately the issues surrounding falsified medicines in a comprehensive, systematic, and sustainable way.
From page 347...
... prioritizing these needs and recommending a strategic approach to FDA's moving forward to address regulatory capacity needs in the context of globalization. In addition to identifying the core elements of regulatory systems development, the consensus study would also identify potential areas in which progress could be made in a 3- to 5-year timeframe; priorities for FDA engagement; and areas to which others (bilateral donors, development banks, foundations, academia, industry and non-governmental organizations)
From page 348...
... Staffing The core staff for the project shall include a senior program officer who will be the lead study director for the committee (100%) ; an associate program officer who will assist in all committee activities (100%)


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