How can the FDA continue to protect and promote the public health in this global marketplace?
Good public health protection demands more than a solid inspection program to manage imports. Faced with this unprecedented increase in products from abroad, the FDA has relied on two primary strategies for helping to assure the quality of these products: harmonization of standards through multilateral fora, and two-party (bilateral) agreements with other nations. In general, the FDA and other nations have entered into harmonization initiatives to assure product quality while at the same time conserving scarce human and financial resources and improving the efficiency of their operations. When nations can agree on scientific standards for establishing the safety, effectiveness, and manufacturing quality of pharmaceutical products, or on standards that help ensure that high-quality medical devices are produced, everyone wins. As useful as they are, these harmonization efforts sometimes do not address specific national needs. That is when the FDA and its international counterparts find i
