Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-22
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From page 15... ...
It is the role of regulators to ensure that quality health care products reach the market. Moreover, although affordability and accessibility are tangential to the scope of most regulatory authorities, both are essential for ensuring a well-functioning public health system, in which quality-assured essential medicines reach those for whom they are intended.
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From page 16... ...
Food and Drug Administration (FDA) works hard to meet its obligations while navigating the increasing challenges and complexities associated with regulating products in a global market. Congress recognized these challenges in establishing FDA's mission by including -- in addition to its public health protection mandate -- a requirement that it "participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements."2 According to FDA's Center for Biologics Evaluation and Research (CBER)
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From page 17... ...
In this global context, it has become clear that higher public health purposes and better resource utilization are best served through harmonization of technical standards and coordination of processes among regulatory authorities around the world. By sharing work and information and supporting one another through collaborative activities, regulatory authorities can bring drugs to market more quickly, avoid drug shortages, lower drug prices, communicate the risks of medicines, and become better prepared to address emerging threats.
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From page 18... ...
CHARGE TO THE COMMITTEE In this context, in September 2018 FDA's Office of International Programs (now the Office of Global Policy and Strategy) charged the National Academies of Sciences, Engineering, and Medicine with convening an ad hoc committee to conduct a landscaping and analysis of mutual recognition and reliance arrangements for pharmaceutical products.
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From page 19... ...
The committee should analyze how the agreements affect the efficiency and stringency of the regulatory system. Specific questions to include are whether the agreements and informal practices enable regulatory agen cies to improve efficiency or redirect resources, and if so, how and what are the long-term implications for regulatory expertise as competencies evolve; • Identify major challenges and opportunities facing national medicines regulatory authorities when implementing mutual recognition agreements; and • Identify other regulatory areas that may lend themselves to these types of agreements and informal practices.
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From page 20... ...
Chapter 2 provides key background information that encompasses the issues characterizing the environment for medicines regulation, definitions of recognition and reliance, and the essential features of recognition and reliance arrangements. Chapter 3 describes how these arrangements can be viewed by policy makers and presents an overview of the regulatory functions of oversight over good manufacturing practice, batch certification, good laboratory practice, and good clinical practice.
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From page 21... ...
Chapter 6 closes with ideas to explore in the future, in particular, the important area of regulatory cooperation on ensuring the safety of medicines after they are available to consumers in the market.
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