Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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2 Core Elements of Regulatory Systems
2 Core Elements of Regulatory Systems
Pages 33-78
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From page 33... ...
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.
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. COMMON ATTRIBUTES OF EFFECTIVE REGULATORY PROGRAMS The first step in understanding the core elements of food and medical product regulatory systems is identifying the underlying attributes of successful systems.
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Furthermore, in an outcome-oriented system, industry has a clear avenue to petition the regulatory authority to use alternative processes, and this process is not unduly onerous. An outcome-oriented regulatory agency has the scientific expertise to be abreast of changes in food and medical product technology and the modern equipment to analyze it.
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By providing manufacturers 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 medical product regulatory authority system, as described in Box 2-2.
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. Regulated Standards Government regulatory authorities choose and enforce product stan dards based on scientific evidence.
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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.
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, 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.
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. This is a challenge to the regulation of food and medical products.
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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.
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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.
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. 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 member states have well-developed drug regulatory agencies (Ratanawijitrasin and Wondemagegnehu, 2002)
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A rigorous review of other national models and global regulatory trends guided the formation of the South African Health Products Regulatory Authority (Ministry of Health of South Africa, 2008)
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The regulation of devices is often in the purview of the drug regulatory authority. In the United States and Europe, the national drug regulatory authorities have monitored device safety since the mid1970s; Australia, Canada, and Japan followed course in 1989, 1998, and 2002, respectively (Gropp, 2011)
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all aspects of food regulation into the purview of one agency. Canada, Denmark, Ireland, the United Kingdom, Germany, the Netherlands, and New Zealand have all consolidated their regulatory authority in the last decade (GAO, 2005)
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Many regional economic communities are active in harmonizing their food and medical product regulations. Since 1980, the WHO has provided a forum for drug regulatory authorities to come together and discuss strengthening their collaborations (WHO, 2011c)
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brings together drug regulatory authorities and pharmaceutical trade associations for the harmonization of standards (ICH, 2010)
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Regulation of medical products is often simpler, but still requires extensive inter-governmental coordination. For example, many Asian nations have more than one regulatory body overseeing the safety and registration of drugs and other medical products (Pacific Bridge Medical, 2011)
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Globalization and international trade have made the world smaller; countries can no longer expect their national regulatory authority to guarantee product safety. The modern food and medical product supply is shared among many countries, and protecting it requires global action (Guenther and McCormick, 2011)
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e ciency WHO Strengthening National Regulatory Capacity building Authorities (WHO, 2003) SOURCE: Adapted from Standards and Trade Development Facility, 2011.
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Building "coordinated networks across and between countries" to stop drug counterfeiting was the goal of the WHO's International Medical Products Anti-Counterfeiting Taskforce (WHO, 2012)
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RISK AND SHARED REGULATORY RESPONSIBILITY This chapter described some differences in the food and medical product regulatory systems in developed and developing countries. International trade and modern manufacturing bring these systems together, however.
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. The FDA's National Advisory Committee on Microbiological Criteria for Foods explains, "The HACCP team conducts a hazard analysis and identifies appropriate control measures.
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The EU recognizes the precautionary principle (Box 2-8) , however.
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. In the EU, a strict interpretation of the precautionary principle states that it "applies where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU (UNESCO, 2005)
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. Regulation of Active Pharmaceutical Ingredients Most pharmaceutical products are manufactured in two basic steps.
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or other stringent regulatory authorities. This would allow for more frequent inspections and better inspection coverage all around,
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All stakeholders should have a way to communicate with the regulatory authority about the rules governing product safety. International cooperation is an important part of a modern food and medical product regulatory system.
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events, share information • Training on risk assessment of global interest, promote • Guidance and training on developing national food partnerships, help countries safety emergency response plans strengthen their capacity to • Tools for outbreak investigation manage food safety risks, and respond to requests for assistance during food safety emergencies. • Establish and improve national regulatory frameworks Worldwide FAO Food Quality Enhancing food safety and Standards Service quality along the supply chain • Provide technical advice on integrated food control (AGNS)
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(UNCTAD) • Research on SPS standards in least developed countries to assess the barriers to entering markets and strengthen capacity to bridge these gaps Asia Pacific • Regulatory frameworks: establish government APEC Food Safety To improve and strengthen endorsed food regulatory systems; develop, Cooperation information sharing in food implement, and enforce food safety standards Forum safety by enhancing coopera tion among member econo- • Food inspection and certification programs: develop mies; and to identify, prioritize, legislative frameworks for food management; establish and coordinate capacity communication systems to support food inspection building in the Asia-Pacific including education and training Economic Cooperation region, • Training in food safety management and risk assessment taking other regional activities • Establishing relevant forums, encouraging collabora into account.
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• Ensure transparency of standards, technical regulations, and conformity assessments Southeast Expert Group on To improve food safety of • Provide assistance to ASEAN governments to Asia Food Safety ASEAN countries, but also develop and strengthen food safety infrastructure to facilitate food trade and and programs formulate a strategic plan to • Food Safety Improvement Plan: identifies 10 priority address important food safety areas for cooperation including a center of excellence issues for mutual benefits. for inspection and certification, consumer participation in food safety, education and training, and increased sharing of food safety information Asia and the • Technical assistance on developing and improving Incorporated into Protection of public health Asian Pacific national systems, use of food safety technologies Development a wide range of through sustainable access regional and country- to safe foods and promotion Bank • Research level programs of economic development.
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– Improving food hygiene control systems – Common food hygiene policies for the region Africa To support improved health • Providing training in SPS measures, handling and proAfrican Incorporated into and nutrition through access to cessing techniques, quality standards Development a wide range of Bank regional and country- safe foods and to promote eco- • Improving infrastructure such as hygienic meat level programs nomic growth through market slaughtering facilities access and income generation. • Improving supply chains with roads and cold chains • Promoting regional standards harmonization 63 continued
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Worldwide • Developing Countries' Vaccine Regulators Network Regulatory Pathway To improve developing coun – The WHO established the network and plays a Initiative tries' ability to regulate new secretariat role vaccines by supporting the de – Forum for discussion of and exposure to policies velopment and implementation and procedures for the evaluation of clinical trial of regulatory strategies for as proposals and clinical trial data sessing clinical trial applications and establishing regulatory • Collaboration with the European Medicines Agency, mechanisms for licensing new the FDA, and other developed regulatory authorities vaccines that are not registered to develop new regulatory strategies for licensing in the country of manufacture. of novel vaccines • Establishment of regional regulatory authority and research center networks to address the short-term need for review of clinical protocols, monitoring trials, and evaluation of trial data • Training and technical assistance for national regula tory authorities (NRAs)
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Access (DFID) projects and – Food control laboratory capacity building research to safe food is critical for health, – Training African trainers to implement food safety and compliance with safety reg- programs based on HACCP ulations is necessary to export food to wealthy countries.
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Development of active and focused systems to ad dress urgent safety questions in priority diseases Projects to improve pharmacovigilance in drugs for Chagas, TB, HIV, and malaria Publications: Worldwide Quality Assurance To develop norms, standards, and guidelines for quality assur- • WHO good manufacturing principles: main principles ance including quality control, for pharmaceutical products (2011) production, distribution, and • Good distribution practices for pharmaceutical inspections.
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Worldwide • Developing Countries' Vaccine Regulators Network Regulatory Pathway To improve developing coun – The WHO established the network and plays a Initiative tries' ability to regulate new secretariat role vaccines by supporting the de – Forum for discussion of and exposure to policies velopment and implementation and procedures for the evaluation of clinical trial of regulatory strategies for as proposals and clinical trial data sessing clinical trial applications and establishing regulatory • Collaboration with the European Medicines Agency, mechanisms for licensing new the FDA, and other developed regulatory authorities vaccines that are not registered to develop new regulatory strategies for licensing in the country of manufacture. of novel vaccines • Establishment of regional regulatory authority and research center networks to address the short-term need for review of clinical protocols, monitoring trials, and evaluation of trial data • Training and technical assistance for national regula tory authorities (NRAs)
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. • 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)
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• 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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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.
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• 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)
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Paper presented at 2nd Annual South African Medical Devices Industry Association (SAMED) Conference, Midrand, South Africa, May 31.
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2011. Core elements of medical device regulatory systems in developing countries.
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2008. Executive summary: Report of the ministerial task team on the restructuring of the Medicines Regulatory Affairs and Medicines Control Council and recommendations for the new regulatory authority for health products of South Africa.
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2008. Executive summary: Report of the ministerial task team on the restructuring of the Medicine Regulatory Affairs and Medicines Control Council and recommendations for the new regulatory authority for health products of South Africa.
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2011c. International conference of drug regulatory authorities.
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2005. First African medicines regulatory authorities con ference: Final report.
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