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Pages 1-12

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From page 1...
... protects consumers from unsafe food and drugs, an ever more complicated task as increasingly food and medical products travel through complex international supply chains. The past 10 years have seen contaminated heparin and pet food reach the American market from foreign factories.
From page 2...
... Finally, a robust regulatory system is independent; it is not unduly influenced by politics or money. The main duties of a medical products regulatory authority are: product registration; the publication of clear licensure requirements; the provision of unbiased information; market entry notification; safety and effectiveness surveillance; quality control testing; inspection of manufacturers against good manufacturing practices; inspection of distributers against good distribution practices; and the evaluation of medical product performance through trials.
From page 3...
... CRITICAL ISSUES IN DEVELOPING COUNTRY FOOD AND MEDICAL PRODUCT SAFETY SYSTEMS The committee identified nine common problems that cut across developing country product safety systems. A brief summary of these nine critical issues follows.
From page 4...
... They cannot monitor medical product safety, track epidemics, or do risk analysis without reliable surveillance data. Weaknesses in the vaccine safety surveillance system can aggravate vaccine scares.
From page 5...
... The American food and medical products market is strictly controlled, as are all of the most lucrative markets. In emerging economies, small- and medium-sized businesses dominate much of the pharmaceutical supply chain and vastly more of the food supply chain.
From page 6...
... An emerging manufacturing nation with a vigorous export economy, Mexico would be an ideal leader for a global initiative on food and medical product safety. The United States and other G20 nations should support Mexico in this effort.
From page 7...
... Sharing inspection reports is an important first step in mutual recognition and international regulatory harmonization. In the next 18 months countries with stringent regulatory agencies should share their inspection reports of facilities in developing countries.
From page 8...
... The committee recommended specific actions that the FDA and other government agencies should take to improve the capacity of regulatory authorities in low- and middle-income countries. The committee's proposed domestic action will: use risk as a guiding principle; use information technology; bridge training gaps; lead in adaptation of international standards; expand the one-up, oneback track and trace requirements; research inexpensive technology; give market incentives for supply chain management; and increase civil liability.
From page 9...
... The FDA should work with international forums such as the World Wide Web Consortium and the Institute of Electronics and Electrical Engineers to work out a minimum key data set that it and its counterparts can collect and share. These are steps to the goal of having a paperless system in the next decade.
From page 10...
... To this end, the FDA should lead in the development and adoption of interna tional and harmonized standards for food and medical products. The FDA is an accepted gold-standard regulatory agency; it should lead by example in the use of international standards.
From page 11...
... The FDA does not have the authority to regulate all the upstream activities in complex international supply chains of food and medical products. The Secure Supply Chain pilot program rewards firms that trace their products thoroughly from manufacture to entry into the United States.
From page 12...
... Individual countries can no longer depend on their national regulatory authorities to guarantee product safety in the domestic market. This report identifies the most pressing problems facing food and medical product regulators in developing countries.


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