Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-40
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. The crisis, occurring at the same time as well-publicized food safety scandals in China, brought to light liabilities in modern, multinational supply chains (Pew Health Group, 2011)
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TABLE 1-1 16 Product Safety Crises Around the World Incident Country Date of Incident or Publication Source Infant formula contaminated with China 2008 Xiu and Klein, 2010 melamine sickens almost 300,000 babies More than 200 deaths and 1,000 Pakistan 2011 WHO, 2013 hospitalizations from contaminated heart medication More than 3,800 cases and 54 Germany 2011 Frank et al., 2011 deaths from Shiga-toxin on sprouts Over 750 people in 20 states United States 2012 CDC, 2015 contract fungal meningitis from contaminated steroid injections, resulting in 64 deaths Between 4 and 16 percent of anti- Angola, Brazil, China, 2013 Bate et al., 2013 tuberculosis drugs sampled from DR Congo, Egypt, pharmacies fail quality testing Ethiopia, Ghana, India, Kenya, Nigeria, Russia, Rwanda, Tanzania, Thailand, Turkey, Uganda, and Zambia Almost a third of emergency Peru 2014 Monge et al., 2014 contraceptives fail quality testing Aflatoxicosis outbreak with 68 cases Tanzania 2016 Kamala et al., 2018 and 20 deaths Between 72,000 and 169,000 child Low- and middle- 2017 Campbell and Theodoratou, pneumonia deaths a year because of income countries 2017 substandard and falsified antibiotics
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Poor quality antimalarials cause Sub-Saharan Africa 2017 Goodman and Yeung, 2017 between 8,500 and 19,800 deaths a year a 1,060 people sickened and South Africa 2017–2018 Whitworth, 2018 at least 216 killed in listeria outbreak Substandard vaccine for China 2018 The Lancet, 2018 diphtheria, pertussis, and tetanus administered to between 215,000 and 615,000 children Cyclosporiasis linked to Fresh United States 2018 CDC, 2018 Express salad mix sold at McDonald's restaurants; 511 confirmed cases in 16 states Contaminated formula causes Belgium, France, and 2018–2019 European Center for 32 cases of salmonella in infants Luxembourg Disease Prevention and and young children Control and European Food Safety Authority, 2019 About 1,700 confirmed cases of United States 2019 CDC, 2018 cyclosporiasis in 33 states a Based on WHO estimates of 435,000 malaria deaths a year, 93 percent in Africa (WHO, 2019)
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The world has changed since the 2012 release of Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. The FDA has also changed, so has donor assistance for health in low- and middle-income countries.
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With this in mind, an ad hoc com mittee 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 af fect 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, develop ment, 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. also advertised on the National Academies' social media, with the National Academies' global health and food and nutrition listservs, and through the committee members' networks.
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Nevertheless, the balance of the material presented in this report is concerned with common principles related to both food and medicines regulation, and the relationship of the field to global health and development. To this end, the report is not divided along interests of food, medicines, and other medical products, but is roughly organized against the Statement of Task shown in Box 1-1.
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While food safety is a topic of this report, the related topic of agricultural development is only tangentially relevant. GLOBALIZATION AND REGULATORY SYSTEMS The FDA Office of International Programs commissioned Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad at a time when several high-profile product safety lapses had called into question the extent to which the United States, or any country, could reasonably guarantee the safety of food and medicines produced and distributed through expansive global supply chains.
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The committee encouraged the agency to move to paperless systems to improve efficiency and to facilitate work sharing among other advanced regulatory agencies, and recommended sharing of inspection reports as a goal for both governments and industry associations. Similarly, global trade and telecommunications have made the world more connected.
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. Investing in safe food and good-quality medical products abroad is one of the best examples of development assistance being in the enlightened self-interest of the donor.
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. The immediate work plan under this mechanism included strengthening national regulatory authorities and quality control labs, and collaborating on surveillance and monitoring of the drug supply (WHO, 2012)
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. New observers in the ICH include the East African Community, the Southern African Development Community, and the Pan American Network of Drug Regulatory Authorities (ICH, 2018)
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. It is hard to overstate the importance of the WHO report and the work of the Foodborne Disease Burden Epidemiology Reference Group.
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. Globalization of the food supply was a key impetus for the Food Safety Modernization Act, which put requirements on food importers to guarantee that foreign producers they work with meet the requirements for the U.S.
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. A recent National Academies committee concluded that, given the complex, global nature of modern drug supply chains, work sharing with other regulatory authorities is an essential part of modern good regulatory practice (NASEM, 2020)
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. This means that even some basic medicines regulatory jobs such as market authorization, inspection, and quality control are neglected in a part of the world with serious health needs and demand for medical products.
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Third Party Audits Food Safety Compliance, Surveillance & Enforcement Food Processing Technology Traceability Systems HACCP Trade Import/Export History of Food Safety Regulations Transportation Outbreak Investigations FIGURE 1-1 Global food and medical product basic curriculum framework for food, STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD
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Critical Thinking Regulatory Framework Ethics and Conduct Food Policy Media Relations International Standards Development Organizations Negotiation Skills Regulatory Impact Assessment Professional Skills Personal Safety Risk Analysis Professionalism Animal Welfare Stakeholder Interaction Team Work International Standards Development Organizations Writing Skills Packaging Environmental Health Product Classification Epidemiology 31 Product Life Cycle Nutrition Personal Hygiene (GMPs) Regulatory Impact Assessment Regulatory Framework Water and Sanitation Risk Benefit Public Health Principles Practicum Practicum Zoology Credentials Schedule or Controlled Substances Global Integration Claim Structures Certificates & Credentials Intellectual Property Good Review Practices International Relations/Cooperation Jurisdiction Product Dating / Expiration Laws and Regulations Product License and Registration Product Registration Application Review & Policies Shelf Life Studies Principles of Quality Management Biomaterials Systems Medical Products Regulatory Framework / Organizational Awareness Clinical Trial Design Regulatory Transparency Openness Product Roles and Responsibilities Naming Conventions Development Rulemaking Process Shelf Life Studies Anatomy Clinical Trial Oversight Thrid Party Audits Facility Design Traceability Systems Good Practices (GXP)
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. It is not yet clear what revisions to the regulatory review process for such technologies might best protect public health without impeding scientific progress.
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This report sets out a cross-cutting strategy to support good-quality, wholesome food, and quality, safe, effective medical products around the world. The goal of this report is to build on the momentum for strengthening regulatory systems developing over the last 10 years and to set a course for continued progress.
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In A study on the public health and socioeconomic impact of substandard and falsified medical products. Geneva, Switzerland: World Health Organization.
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In A study on the public health and socioeconomic impact of substandard and falsified medical products. Geneva, Switzerland: World Health Organization.
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2012. Ensuring safe foods and medical products through stronger regulatory systems abroad.
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2017c. WHO global surveillance and monitoring system for substandard and falsified medical products.
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2018. Reforming China's drug regulatory system.
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