Stronger Food and Drug Regulatory Systems Abroad

Type: Consensus Study
Topics: Global Health, Public Health, Environmental Health, Health Security
Board: Board on Global Health

Activity Description


The 2012 IOM report Ensuring Safe Food and Medical Products through Stronger Regulatory Systems Abroad put considerable emphasis on capacity building in developing countries as a means to improve the safety of food and drugs around the world. Recommendations called for building regulatory agencies in low- and middle-income countries; strengthening the scientific and technical underpinning for regulatory policy and action; increasing technical support for post-market surveillance; and placing regulatory systems in the global economic, development, and trade agenda. While progress has been made on these goals, the global regulatory landscape has changed significantly since 2012. It is therefore timely to assess progress made towards these goals and the current regulatory landscape. With this in mind, an ad hoc committee convened by the National Academies of Sciences, Engineering, and Medicine should: 

  • Assess how the challenges and opportunities facing regulators have changed since 2012 and how technology and innovation effects their work; 
  • Discuss the transition off donor aid and the capacity of regulatory systems to ensure the safety and quality of regulated products; the lack of post-market surveillance in many countries; and the challenges of regulating the informal medicines market;
  • Recommend ways to increase scientific robustness at food and drug regulatory agencies in low- and middle-income countries;
  • Identify concrete steps to raise visibility and increase investment in global food and drug safety as part of global health, development, and trade programming of the United States government and internationally, and;
  • Examine the priority given to food and drug regulatory systems in low- and middle-income countries and suggest ways to increase will for developing such systems at the national or regional levels.

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