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A key objective of medicines regulatory authorities is to protect public health by ensuring the quality, safety and efficacy of medicines. Medicines regulatory authorities use mutual recognition/reliance agreements and informal practices of recognition/reliance in various range and approaches. At the request of the U.S. Food and Drug Administration's Office of International Programs, the National Academies have convened a committee to analyze and assess how the regulatory authorities of different countries use such regulatory practices and will evaluate their effects on public health, use of resources, and essential regulatory competencies.
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Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators
Consensus Study Report
·2020
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in coun...
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