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Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
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Appendix D: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Pages 217-224

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From page 217...
... Appendix D Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad 217
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From page 218...
... has requested that the Institute of Medicine convene a consensus study to assist the FDA in: (A) Identifying the core elements of needed pharmaceutical, biologics, medical device, and food safety regulatory systems development in developing countries; and in (B)
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From page 219...
... Given that "developing countries" include a heterogeneous group of about 150 low- and middle-income countries, for the purposes of this study emphasis will be given to understanding in some depth the issues for a limited number of countries that currently are or are expected to soon become major pharmaceutical and agricultural trading partners with the United States (e.g., Mexico, Brazil, South Africa, India, Thailand, and China)
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From page 220...
... Investments in international food and medical product safety should be a significant and explicitly tracked priority at development banks, regional economic communities, and public health institutions. International organizations should provide assistance to achieve meaningful participation of developing country representatives at international harmonization and standardization meetings.
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From page 221...
... Recommendation 6-4: U.S. policy makers should integrate food and medical product safety objectives into their international economic development, trade, harmonization, and public health work.
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From page 222...
... 222 STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD TABLE D-2 Gaps in Regulatory Systems in Developing Countries Gaps Problems Food Systems Medical Product Systems Adherence to • Lack of awareness of • Problems adhering to international public health risks quality standards standards • Lack of funding and • Lack of funding expertise for quality-control • Lack of adherence to laboratories manufacturing and • Challenges agricultural standards implementing good manufacturing practices • Inconsistent adherence to international research standards Controlling supply • Lack of good • Inefficient post-market chains transportation and surveillance storage • Lack of optimal storage • Inadequate equipment • Lack of modern information technology and supply chain management Infrastructure • Lack of laboratories, manufacturing, and market infrastructure • Lack of information technology and communication • Lack of reliable electricity, water sanitation, and pest control • Lack of adequate roads Laws • Outdated or poorly coordinated laws governing food or drug safety • Lack of enforcement of existing regulations Workforce • Too few regulatory staff • Insufficient technical training for staff • Problems retaining staff
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From page 223...
... APPENDIX D 223 TABLE D-2  Continued Gaps Institutional • No clear assignment of responsibilities or established fragmentation protocol for enforcement, unclear chain of command • Lack of established communication channels between and within agencies Surveillance • Passive foodborne • Lack of disease surveillance pharmacovigilance • Lack of food chain systems security and information • Passive or spontaneous sharing adverse event reporting • Lack of active and post market surveillance Communication • Lack of communication within a regulatory authority and across government agencies that share regulatory responsibility • Lack of communication between regulatory authorities and regulated industry • Lack of communication between the regulatory authority and the public • Lack of communication with counterpart regulatory agencies abroad Political will • Competing priorities and limited budgets • Corruption and lack of accountability SOURCE: IOM, 2012.
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From page 224...
... A food and medical product regulatory system integrates: • product safety through good manufacturing, clinical, laboratory, and agricultural practices; • staff development and training for employees; • monitoring and evaluation of product quality using laboratories; • inspection and surveillance of products throughout the supply chain; • risk assessment, analysis, and management; and • emergency response. Protecting the public's health is crucial in a food and medical prod uct regulatory system.
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Key Terms

  • medical product
  • product safety
  • core elements
  • regulatory authorities
  • consensus study

  • supply chain
  • product regulatory
  • development banks
  • ensuring safe
  • enterprise risk

  • developing country
  • market surveillance
  • regulatory authority
  • disease surveillance
  • safe foods

  • help meet
  • national regulatory
  • international harmonization
  • regulatory science
  • fda secure

  • standardization meetings
  • study emphasis
  • economic communities
  • moving forward
  • fda resource

  • verification technologies
  • country representatives
  • fda staffers
  • critical issues
  • tracked priority


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