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Core Elements of Regulatory Systems

Having safe food and medical products is a cornerstone of public health around the world. The U.S. Food and Drug Administration (FDA) protects U.S. consumers from tainted products, and increasingly it works with its counterpart agencies abroad to the same ends. Before identifying the common gaps in developing country food and medical product regulatory systems, and before making a strategy to bridge these gaps, the committee identified the core elements of a functional regulatory system. The committee concluded that the most basic elements of a regulatory system are the same around the world. Therefore, the core elements of regulatory systems are the same in developed and developing countries. This chapter describes these elements as well as the minimal pieces necessary for an effective food and medical product regulatory system.

There is more than one right way to organize a regulatory system. In its analysis, the committee considered a number of different policy and administrative tools governments can use to ensure the safe manufacture, labeling, distribution, and marketing of food and medical products. While the mechanisms employed can vary between countries, effective regulatory programs have a number of common characteristics.

This chapter lays out the characteristics and practical elements of a good regulatory system. It also describes the minimal elements necessary to ensure food and medical product safety. It provides an overview of the organization of food and medical product regulatory systems in developing countries, paying special attention to the importance of harmonized standards in these countries. The importance of international cooperation among regulators is introduced; the committee will concentrate on this



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2 Core Elements of Regulatory Systems Having safe food and medical products is a cornerstone of public health around the world. The U.S. Food and Drug Administration (FDA) protects U.S. consumers from tainted products, and increasingly it works with its counterpart agencies abroad to the same ends. Before identifying the common gaps in developing country food and medical product regulatory systems, and before making a strategy to bridge these gaps, the committee identified the core elements of a functional regulatory system. The commit- tee concluded that the most basic elements of a regulatory system are the same around the world. Therefore, the core elements of regulatory systems are the same in developed and developing countries. This chapter describes these elements as well as the minimal pieces necessary for an effective food and medical product regulatory system. There is more than one right way to organize a regulatory system. In its analysis, the committee considered a number of different policy and administrative tools governments can use to ensure the safe manufacture, labeling, distribution, and marketing of food and medical products. While the mechanisms employed can vary between countries, effective regulatory programs have a number of common characteristics. This chapter lays out the characteristics and practical elements of a good regulatory system. It also describes the minimal elements necessary to ensure food and medical product safety. It provides an overview of the organization of food and medical product regulatory systems in develop- ing countries, paying special attention to the importance of harmonized standards in these countries. The importance of international cooperation among regulators is introduced; the committee will concentrate on this 33

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34 ENSURING SAFE FOODS AND MEDICAL PRODUCTS theme throughout the report. This chapter ends with a discussion of two important points of international cooperation: the use of risk and hazard analysis in food safety and the regulation of active pharmaceutical ingre- dients (APIs). COMMON ATTRIBUTES OF EFFECTIVE REGULATORY PROGRAMS The first step in understanding the core elements of food and medi- cal product regulatory systems is identifying the underlying attributes of successful systems. The committee identified five main characteristics of good systems: they should be responsive, outcome-oriented, predictable, risk-proportionate, and independent. These attributes are consistent with those outlined in the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), especially in their emphasis on the protection of human, plant, and animal health without the application of regulations that would “arbitrarily or unjustifi- ably discriminate between countries where identical or similar conditions prevail” (WTO, 1998). Similarly, the WTO relies on a scientific evidence base for decision making. Its preference is to use international standards whenever possible, but does allow countries to set their own standards so long as their standards comply with the basic tenets of the WTO rules. The major attributes the committee identified are common to all highly functioning regulatory systems. These attributes are not the system’s main duties, which will be discussed later, but are scientific and philosophical underpinnings of a robust system. Responsive The responsiveness of a regulatory system involves two related func- tions. The first is the ability to respond rapidly to a crisis. The regulatory system should be able to contain and correct any product safety lapse that has occurred, minimizing the health effects. Responsiveness also includes the ability of the system to promptly modify its policies. Responsive regu- lation keeps pace with the emergence of new hazards, changes in technol- ogy, expanding evidence base, and evolving consumer expectations. This attribute also includes the ability of the system to stay up-to-date and knowledgeable about new science. Responsiveness refers to the ability of the regulatory agency to continually expand its knowledge base, to be a learning organization that has internal scientific depth and effective collabo- ration with academics, and to draw on the technical and business expertise of regulated industry.

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35 CORE ELEMENTS OF REGULATORY SYSTEMS Outcome Orientation A robust regulatory system focuses on product safety outcomes, not on the details of how to arrive at the outcomes. That is not to say that a strong system is not concerned with process. On the contrary, strong regulatory systems often stipulate manufacturing standards and inspection processes. Rather, the outcome-oriented system issues regulations that do not get in the way of innovation. Furthermore, in an outcome-oriented system, indus- try has a clear avenue to petition the regulatory authority to use alternative processes, and this process is not unduly onerous. An outcome-oriented reg- ulatory agency has the scientific expertise to be abreast of changes in food and medical product technology and the modern equipment to analyze it. Predictable The regulatory agency has a clear framework guaranteeing that the regulators’ decisions are neither arbitrary nor capricious. Predictable regu- latory systems make their procedures readily available to the public. The rules are applied consistently, enforced fairly, and are based on the best sci- entific evidence available at the time of the decision. Predictability assumes a level playing field and describes a function in the regulatory system that is vigilant against bias. A fair and predictable system does not work for or against large industry or small industry; regulations are applied the same way to imported and domestic products. Proportional A proportional or risk-based system allocates controls based on threat to public health: product lapses with serious health consequences are moni- tored stringently, while those with few or insignificant risks receive less attention. Products with similar risks are regulated in similar ways. Propor- tionality depends first and foremost on the ability of the regulatory agency to assess risk. It also assumes that the agency will consider a cost-benefit analysis when measuring the impact of potential risk management options. A proportional regulatory system actively sets priorities ensuring that the agencies’ programs give the most attention to the most pressing public health threats. Independent Regulatory policies are the combination of scientific decisions and soci- etal expectations. This is especially true of the system’s legislative oversight. However, once its legal authority is set, the agency functions best when it

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36 ENSURING SAFE FOODS AND MEDICAL PRODUCTS is independent of the political process. The predictability of a regulatory system also relies on independence: regulated industry cannot predict how and when regulations will be enforced if the enforcer changes every time the political regime does. Consumer trust depends on independence. The public needs to know that the agency is devoted to its best interests and is not unduly influenced by politics or money. Approaches to Regulation Good food and medical product regulation strikes a balance between protecting public health and not unfairly restricting market access. To this end, governments need to ensure that companies comply with regulations, but governments do not function alone. Industry, academia, and consumers give important feedback to the regulatory system, which includes the legal and health systems. The best regulatory model is one that engages all stakeholders. Box 2-1 describes approaches to food and medical product regulation that emphasize the role of consumers and regulated industry. CORE ELEMENTS OF A STRONG REGULATORY SYSTEM Responsiveness, outcome orientation, predictability, proportionality, and independence are the underpinnings of strong food and medical prod- uct regulatory systems. A regulatory system grounded in these values will be able to execute its core responsibilities. The main duties of a medical product regulatory system are: the registering of medicines; the publishing of clear requirements for licensure; the provision of unbiased informa- tion; market entry notification; safety and effectiveness surveillance; quality control testing; the inspecting of manufacturers for compliance with good manufacturing practices; inspection of distributors; and the evaluation of performance through authorized trials (WHO, 1999, 2001, 2003a). In coun- tries that manufacture vaccines, the regulatory authority is also responsible for the systematic lot release of the vaccine (WHO, 1999). The main duties of a food regulatory system are: providing unbiased education and advice to all stakeholders; inspecting food production and processing plants; evalu- ating hazard analysis and critical control point (HACCP) plans; physical, chemical, and microbiological analysis of food and food additives; and epidemiological surveillance (FAO/WHO, 2003). Essentially, the regulatory system is an important piece of the public health system. By providing manu- facturers and producers with unbiased information, guaranteeing the use of best practices, and inspecting producers and manufacturers, the regulatory authority protects the safety of food and medical products. The committee also identified the core elements of a food and medi- cal product regulatory authority system, as described in Box 2-2. Whether

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37 CORE ELEMENTS OF REGULATORY SYSTEMS BOX 2-1 Approaches to Regulation Informational Approaches One technique for ensuring strong product safety regulation is edu- cation. An informational approach directly educates the consumer on product safety and assumes that consumers will use this information to make the best decisions for themselves. This approach assumes that having more information, particularly about the concealed characteristics of products, will cause people to change their behavior and buy safe products (IOM, 2006). Governments, industry, academia, or other orga- nizations can provide this information, although the British government’s Department for Business, Innovation, and Skills explains that consumer education is best done by non-governmental organizations, leaving the government free to enforce regulations (BIS, 2011a). Labeling, warnings, and safety rating systems are important tools in informational regulation (BIS, 2011a; Sunstein, 2011). Market Approaches Market approaches to regulation use monetary rewards and punish- ments to modify behavior. Market regulation gives government control of the final regulatory action while putting industry in charge of the route there. Proponents of the market approach maintain that market controls also empower consumers to make their own cost-benefit esti- mates and choose products based on these decisions. Taxes on products with negative externalities, such as soft drinks, are a market approach to regulation. Bonded warranties are another market tool sometimes used in food and drug regulation to ensure product safety (BIS, 2011b; Office of Information and Regulatory Affairs, 2003). Regulated Standards Government regulatory authorities choose and enforce product stan- dards based on scientific evidence. They use either performance standards or design standards. Performance standards set the final product require- ments, but do not mandate the techniques industry must use to meet these standards. Design standards dictate the means as well as the end product of the product requirements. Proponents of performance stan- dards explain that they encourage innovation, while advocates of design standards emphasize the process as much as the product (IOM, 2006; Office of Information and Regulatory Affairs, 2003).

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38 ENSURING SAFE FOODS AND MEDICAL PRODUCTS BOX 2-2 Core Elements of a Food and Medical Product Regulatory System Government is the foundation for a strong regulatory system. As the national standard-setting body, governments: • u se science and risk as a basis for developing policy; • p articipate in international cooperation and harmonization of standards; • m ake ethical decisions; and • r ecognize, collect, and transmit evidence when breaches of law occur. A food and medical product regulatory system integrates: • roduct safety through good manufacturing, clinical, laboratory, and p agricultural practices; • taff development and training for employees; s • onitoring and evaluation of product quality using laboratories; m • nspection and surveillance of products throughout the supply chain; i • isk assessment, analysis, and management; and r • mergency response. e Protecting the public’s health is crucial in a food and medical product regulatory system. The system needs to quickly communicate informa- tion to the public in emergencies to ensure the public’s safety. SOURCES: Ratanawijitrasin and Wondemagegnehu, 2002; WHO, 2003a; WHO Regional Committee for Africa, 2006. some or all of the core elements noted in Box 2-2 are part of a country’s regulatory system depends heavily on wealth and infrastructure. It is diffi- cult for companies to manage their supply chains without reliable transpor- tation systems, for example. Political will to enforce product safety laws can also be variable. A more detailed analysis of the issues developing country regulators face in implementing safety controls follows in Chapter 3. MINIMAL ELEMENTS OF A REGULATORY SYSTEM The ideal regulatory system described above depends on funding, infra- structure, workforce, and political commitment. One or more of these is usually missing in low- and middle-income countries (Brown et al., 2006). With this in mind, the committee also identified the minimal elements of a regulatory system that protects public health and ensures product safety.

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39 CORE ELEMENTS OF REGULATORY SYSTEMS The minimal elements of regulation should be the top priority for develop- ing countries trying to build product safety systems. A Rule-Making System The minimal requirements outlined in Box 2-3 focus on the process regulators use to make regulations and on the data they use to enforce them. An open rule-making system ensures that people governed by a new regulation have a chance to publically comment on it (U.S. Department of State, 2011). Through an open rule-making process, consumers and indus- try are informed of proposed food and medical product regulations before they take effect. An open system for rule making involves stakeholders in a regulatory dialogue and lays the groundwork for risk communication. For example, a rule-making process is critical to establishing effective food safety laws. In many developing countries there are food safety rules in place, but there is a lack of processes to ensure their implementation and effectiveness. In Canada, the European Union (EU), and the United States, rule processes have been established to assess risks, analyze cost-benefit and cost-effectiveness, and assess the environmental impact of food safety regulations (European Commission, 2011; Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994, P.L. 103-354; B OX 2-3 M inimal Elements of a Regulatory System At a minimum, a food and medical product regulatory system should include: • n established process for rule making; a • protocol to coordinate work within and across the agencies respon- a sible for regulation, especially during a crisis; • system for stakeholder public comment on regulations and the a review process; • way to identify when a regulatory action is necessary; and a • means to enforce its regulations. a To this end, regulators need to have surveillance data and understand their data sources. They should also have a strong enough understanding of their system’s weaknesses that they can identify data gaps and know what assumptions to make about unknowable data and when to rely on the private sector for additional information. Crisis early warning systems are invaluable tools to make the most of limited surveillance data.

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40 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Health Canada and Canadian Food Inspection Agency, 2007; National En- vironmental Policy Act of 1969, P.L. 91-190). Many developing countries including China, India, the Philippines, Vietnam, and Thailand are in the process of reorganizing their food safety systems (Fairclough, 2009; FAO, 2004; Ramos and Oblepias, 2002; Smart, 2011; WHO, 2009). Box 2-4 discusses the changes India has made to its food safety rules to develop a farm-to-table approach. Openness in rule making is not part of the political tradition in some countries, particularly those with one-party governments or an authoritar- ian history (Dalpino, 2000). This is a challenge to the regulation of food and medical products. By definition, food and medical product safety laws govern regulated industry; it is imperative that the regulated understand B OX 2-4 Rule Making in India In 2006, the Indian government established the Food Safety and Standards Act. The act “aims to establish a single reference point for all matters relating to food safety and standards” (Palthur et al., 2009). This act formed the Food Safety and Standards Authority of India (FSSAI). FSSAI’s mandate is to consolidate previous food laws, make science- based food standards, and regulate and monitor the manufacturing, processing, storage, distribution, sale, and import of foods to ensure safe food for human consumption (FSSAI, 2011; Palthur et al., 2009). Although India has made strides to improve its food safety rules, implementing the rules is difficult. Small-scale producers, who do not know how to make the changes required by law, cannot comply with the act (Palthur et al., 2009). Some producers are unclear about the terms of the act; others simply cannot implement HACCP and good manufacturing processes. In a 2010 survey of the Indian food processing sector, 28.51 percent of respondents identified bottlenecks in the imple- mentation of food safety laws as a concern (FICCI, 2010). Many of the quality-control laboratories lack proper equipment and reliable power, complicating the task of surveillance. There are also not nearly enough of them (Palthur et al., 2009). In January 2011, the FSSAI published a final draft of the Food Safety and Standards rules. In the draft, it specifies how to implement the rules established by the 2006 Food Safety and Standards Act. The new rules replace the country’s outdated food adulteration rules from 1955 (Singh, 2011). Other changes include the establishment of state-level licensing authorities, the addition of batch numbers to processed foods for easy product recalls, laboratory expansion, and the requirement for producers to have a surveillance plan (Smart, 2011). India is clearly making progress toward a farm-to-table approach.

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41 CORE ELEMENTS OF REGULATORY SYSTEMS the rules governing them. Without a public comment period it is doubtful manufacturers are even aware of the regulations affecting them. Regulators are also held back if they cannot receive feedback on their practices from a range of stakeholders. In the United States, for example, there is an open comment period where all stakeholders can submit comments on proposed rules, including those of the FDA (Regulations.gov, 2012). Involving All Stakeholders Part of the problem in developing countries is that the food and, to a lesser extent, the medical products industry are made up of many small pro- ducers. In China, 80 percent of food producers have fewer than 10 employees (Roth et al., 2008); India has more than 20,000 drug manufacturers (KPMG International, 2006). Involving so many stakeholders in public forums is challenging, especially when the communication system is not strong and the tradition of two-way comment on law making is not entrenched. Chapter 3 will discuss these gaps in more detail. Legal Basis to Enforce Regulations The end goal of an orderly rule-making process that involves industry, government, consumers, and academics, is to have a set of enforceable regu- lations. The committee believes that, at a minimum, the regulatory agency needs to have the legal authority to enforce its rules. To this end, the regu- lations must be enforceable by the national regulatory authority. Box 2-5 describes the goals of food and medical product legislation. As Chapter 3 describes, many developing countries have problems with enforcing or even developing coherent product safety laws. FOOD AND MEDICAL PRODUCT REGULATION IN DEVELOPING COUNTRIES There is a continuum of regulatory capacity in the world. On one end, there are the so-called stringent regulatory agencies of the United States, Canada, Western Europe, Australia, New Zealand, and Japan, with high standards and consistent enforcement. These agencies may struggle to monitor all of their regulated products, especially their imports, but they are nonetheless considered gold standards for product safety. At the other end, there are the regulatory agencies of the least developed countries, many in sub-Saharan Africa and in South and Southeast Asia that may not have a single food control laboratory or a system for medicines registration, one of the most basic functions of a drug regulatory authority. In the middle there are many emerging manufacturing nations including India, China, Brazil,

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42 ENSURING SAFE FOODS AND MEDICAL PRODUCTS BOX 2-5 Food and Medical Product Legislation The World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) give good guidance on what a food and medical product legal framework should include. The follow- ing summary of the role of food and medical product safety legislation comes from the WHO’s Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality, and the FAO and WHO’s Assuring Food Quality and Safety: Guidelines for Strengthening National Food Control Systems. • S tate the purpose of regulation; • D efine the categories of products and activities to be regulated; • E nsure legal provision for the creation of a regulatory authority; • C oordinate responsibilities when the regulatory authority includes more than one agency; • C reate mechanisms for ensuring transparency and accountability of regulation; • D efine the roles, responsibilities, rights, and functions of all parties involved in the manufacture and trade of food and medical products, and also in the use of medicines; • S et the qualifications and standards required for all those who handle medicines and biologics; • D efine the norms, standards, and specifications to be applied in as- sessing product quality, safety, and (in the case of medicines and biologics) efficacy; • I nclude clear provisions that the primary responsibility for product safety and quality lies with the producers and processors; • S tate the terms and conditions for suspending, revoking, or canceling activity and product licenses; • D efine prohibitions, offenses, penalties, and legal sanctions; • C reate mechanisms for government oversight to assess implementa- tion of regulations; • R ecognize the country’s international obligations in relation to trade; and • I nclude provisions for the rights of consumers to have access to accu­ rate information. SOURCES: FAO/WHO, 2003; WHO, 2003b. South Africa, Mexico, and Thailand, representatives of which the commit- tee heard from during this study. These countries are leaders in regional harmonization efforts, but they have problems with training and regulatory infrastructure. Across low- and middle-income countries there are some common gaps in the ability to enforce standards, monitor producers for use

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43 CORE ELEMENTS OF REGULATORY SYSTEMS of best practices, run surveillance systems, issue product recalls, or respond to emergencies. Chapter 3 will describe these gaps. Medical Products Regulatory Oversight The Organisation for Economic Co-operation and Development (OECD) Regulatory Policy Committee stressed the importance of regula- tory oversight bodies in government to ensure fair and quality regulation (OECD, 2009). Drug and Vaccine Regulation and WHO Prequalification Oversight bodies are a core element of proper food and medical products regulation, yet according to the WHO, less than 20 percent of its 191 mem- ber states have well-developed drug regulatory agencies (Ratanawijitrasin and Wondemagegnehu, 2002). In the African region, the WHO found that only 10 percent of medicines regulatory authorities have a full system in place (WHO Regional Committee for Africa, 2006). Box 2-6 describes how South Africa restructured its drug regulatory authority. In some countries, the WHO Prequalification Programme is an impor- tant piece of the drug and vaccine regulatory oversight. This program was established in 2001 to ensure that the medicines supplied by United Nations (UN) agencies were safe and efficacious (WHO, 2010). The prequalification process has five steps. First, the WHO or another UN agency invites drug or vaccine companies to submit a product for prequalification. Products considered are either on the WHO essential medicines list, applying for inclusion on the WHO essential medicines list, or recommended for use in a WHO treatment guideline (WHO, 2010). The manufacturer submits a dossier on the product’s safety and efficacy, and a team of experts from regulatory agencies around the world reviews the dossier. Next, inspectors verify that the factory, laboratories, and research mentioned in the dossier all meet international best practices. If the manufacturer passes all inspec- tions, the WHO grants prequalification (WHO, 2010). Originally, WHO prequalification was granted only to HIV, tuberculo- sis, and malaria drugs (WHO, 2010). Now UN agencies procure more than 240 medicines, vaccines, and contraceptives through the prequalification program (WHO, 2010, 2011e). As part of the program, the WHO provides training for national regulators and for manufacturers from private com- panies, and improves quality control laboratories in developing countries (WHO, 2010). In places where the regulatory authority lacks technical depth, this program is a welcome guarantee of medicines quality. In countries that manufacture vaccines, WHO prequalification depends on the country having a competent national regulatory authority (Brhlikova

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TABLE 2-3 Continued 68 Organization Project Objective Activities Where • Establish guidelines for national health technology Worldwide WHO Global initiative on To establish a framework for the programs Department of health technologies development of national health Essential Health technology programs; and to • Develop methodologies to help member states Technologies support World Health Assembly conduct assessments resolution 60.29, which urges • Identify national, international, and global standards member states to have guide- for countries to identify their gaps and future needs lines for good manufacturing • Create tools to implement gaps in policies and regulatory practices, to • Publishes WHO documents on designing and imple- establish surveillance systems, menting e ective medical device regulatory systems and to participate in interna- tional harmonization (other major objectives not related to safety or regulatory capacity building). • Partnerships Worldwide World Bank Incorporated into To assist countries in improv- – Partner in the African Medicines Regulatory a wide range of ing the health, nutrition, and Harmonization Initiative projects, primarily population outcomes of poor in its Health, Nutrition people via strengthening the • Research and Population health care systems and secur- • Overall HNP strategy includes improving health (HNP) sector ing sustainable health financing. governance, health systems strengthening, supply To protect the most vulner- chain management, access to medicines able from the impoverishing • Country-level investment e ects of illness, malnutrition, and high fertility by developing health policies that enhance the knowledge, skills, and values leading to equitable economic and human development.

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Organization Project Objective Activities Where Harmonization and capacity building e orts in: The Americas PAHO Pan American To maintain a constructive dia- Network for logue among drug regulatory • Bioequivalence Drug Regulatory authorities and other stakehold- • Biotechnological products harmonization ers, adopt guidelines on spe- • Counterfeit medicines cific aspects of regulation, and • Good clinical, laboratory, and manufacturing practices promote technical cooperation among countries. • Medicine manufacturing plants • Medicines classification and registration • Pharmacopeia • Pharmacovigilance • Vaccines • Research on harmonization policies and best practices Asia Pacific APEC APEC Harmonization Increase regulatory harmoniza- Center tion among member states with • Education and training, including fellowship programs the goals of supporting access • Establish strong information exchange networks to best practices, information • Maintain online publications exchange, and clinical trials that • Develop and disseminate harmonization models meet international standards and to improve the quality, • Support international cooperation safety, and e cacy of medi- cal products to enhance health outcomes and facilitate interna- tional trade. • GMP training Southeast ASEAN ACCSQ Pharmaceuti- The harmonization of pharma- Asia cal Product Working ceutical regulations to facilitate • Implementation of common technical requirements Group the goals of the ASEAN Free • Mutual recognition agreements for GMP inspections Trade Area, particularly • Shared postmarket surveillance information eliminating technical barriers • Vaccine regulation capacity building to trade, without compromis- ing the quality or safety of medicines. 69 continued

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TABLE 2-3 Continued 70 Organization Project Objective Activities Where • Create a collaborative network of regional Sub-Saharan African Medicines To improve health by increas- NEPAD, WHO, regulatory authorities Africa Regulatory ing access to safe and e ective World Bank, medicines of good qual- Gates Foun- Harmonization • Harmonize technical requirements of medical products ity through strengthening the dation, DFID, Initiative and build confidence so that standards are respected technical and administrative Clinton Health by participating authorities capacity of national medicines Access Initiative • Establish a framework for joint evaluations of regulatory authorities. applications and inspections of manufacturing sites • Strengthen the capacity for regulatory oversight • Develop information management systems and promote the exchange of regulatory information • Harmonizing regional regulations Southern SADC Pharmaceuti- To strengthen the capacity of South African Africa cal Programme member states and to mitigate Development • Strengthening regulations and enforcement the threat of diseases that are Community infrastructure major public health concerns (SADC; with • Educating and retaining competent pharmaceutical by increasing access to quality support from sta ; strengthening regional training centers medicines. the African • Promoting joint procurement of quality essential Development medicines Bank) • Maximizing research and production capacity of quality, generic essential medicines • Assessing gaps in national regulatory authorities and laboratories Worldwide • Strengthen information and evidence so the FDA O ce of International Defines regulatory capacity, the FDA can make informed decisions about how to use Programs, Techni- ability of national regulatory its resources cal Cooperation and authorities to perform regularly Capacity Building their core functions to ensure • Transfer its expertise and identify training the availability of high-quality e orts globally that do not require the use of and safe food and medical FDA resources products, as part of the FDA • Encourage global information networks to strengthen mission to ensure safe products detection, surveillance, and assessment systems in the United States. • Support surveillance and tracking e orts for global supply chains • Support pharmacovigilance capacity

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Organization Project Objective Activities Where • Improving governance in the pharmaceutical sector Worldwide To build capacity within poor USAID and Strengthening countries to e ectively manage Management Pharmaceutical • Strengthening pharmaceutical and laboratory manage- pharmaceutical systems, success- Sciences for Systems ment systems fully implement USAID priority Health • Containing the mergence and spread of antimicrobial services, and protect public health resistance by improving access to and use • Expanding access to medicines of quality-assured medicines. Worldwide USP Promoting Quality A 5-year, USAID-funded project • Strengthen national quality control programs: of Medicines to address poor-quality medi- – Build the capacity of national quality control cines in developing countries laboratories and to assure the quality, safety, – Support medicines registration, inspections, and e cacy of medicines for laboratory testing, and postmarket surveillance USAID priority diseases. • Increase supply of quality-assured medicines by o ering technical assistance to manufacturers on WHO prequalification • Combat substandard and counterfeit medicines by devel- oping testing mechanisms, conducting quality research on essential medicines, and providing technical support for detecting and monitoring substandard medicines • Provide technical leadership and global advocacy on the dangers of substandard medicines Worldwide Brighton A non-profit, scientifically • Set vaccine safety research standards and provide Collaboration independent partnership common terminology with the goal of conducting • Build research capacity and promoting high-quality • Joined with the WHO and Gates Foundation to build vaccine safety research. vaccine safety monitoring • Developed network of local vaccine experts to serve as a global vaccine safety resource • Developed pilot infrastructure (with the European Center for Disease Prevention and Control) to link electronic records and an online classification tool • Established a virtual online research institute to facilitate communication • Plans to develop a vaccine training program 71

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