Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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Fulfilling this mission in a time of rapid scientific change, increasing complexity of medicines, and globalization of production and product supply chains has presented regulatory authorities with multiple challenges while also opening doors to opportunities in the form of greater regulatory cooperation and information sharing among the regulators. It was in this context that the U.S.
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The strategy targets multiple stakeholder groups with an expressed interest in public health and patient care. Within this strategy, each group is called on to play a role in enhancing regulatory cooperation in the form of recognition and reliance arrangements that range from informal, collaborative activities to the most formal -- a mutual recognition agreement (MRA)
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sets guidelines for ensuring that laboratory data are of high quality and reliable in the preclinical phase; good clinical practice (GCP) guides aspects of studies involving human subjects; good manufacturing practice (GMP)
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RECOGNITION AND RELIANCE As defined by the World Health Organization (WHO) , recognition occurs when a regulatory authority accepts the regulatory decision of another authority "as its own decision." Reliance takes place when a regulatory authority takes into account the work products of another authority (e.g., inspection reports, scientific assessment reports, joint assessment reports produced together with another authority)
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If trust and confidence are satisfactorily built, authorities may consider engaging in formal and/or informal recognition or reliance arrangements, the most formal of which are MRAs. Figure S-2 shows how trust and confidence are
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While less formal reliance arrangements promote the sharing of information and facilitate fewer redundant inspections and other regulatory activities, MRAs allow regulatory authorities not just to rely on each other's work products but to recognize them officially as equivalent to their own. However, this is possible only if shared reports are complete and essentially free from redactions.
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In confronting the global challenges of medicines regulation, cooperation and collaboration among regulators offer opportunities to share information and increase the transparency of each other's activities; to share finite resources and address the growing workload resulting from globalization; and to rely on each other's processes, work products, and decision making via both formal reliance arrangements such as MRAs and other, less formal arrangements. Based on its extensive deliberations and input from stakeholders representing regulatory authorities, international organizations, industry, and patient groups, the committee agreed that public health must be at the center of all medicines regulatory recognition and reliance arrangements.
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Each of these stakeholder groups has a role to play in supporting efforts to enhance cooperation among regulatory authorities, with the overarching aim of improving public health. The committee therefore recommends that all regulatory authorities and other key stakeholder groups demonstrate their support for formal and informal medicines regulatory recognition and reliance arrangements using a targeted approach.
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Patient and consumer groups should support the recognition and • reliance efforts of medicines regulatory authorities by advocating for a "public health protection and promotion" framing of all such arrangements and for their increased use. The committee further believes, based on its information gathering and expert opinion, that formal and informal recognition and reliance arrangements are highly effective tools for facilitating cooperation and reliance on the work of other regulatory authorities, when they are established in ways that emphasize public health, maximize efficiencies, reduce the burden of redundancy, and have the potential to benefit both global and national public health by ensuring effective and efficient access to safe and effective quality medicines.
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Recommendation 3: The committee recommends that regulators consider increasing the current scope of both formal and less formal reliance arrangements, including mutual recognition agreements, and that policy makers encourage regulatory authorities to explore formal and informal opportunities for reliance arrangements with other trusted regulatory authorities that give regulators greater flexibility in responding to challenges that affect their responsibility in overseeing the quality, safety, and efficacy of medicines throughout the medicines' lifecycle. Potential areas identified for such expansion of scope include good laboratory practice, good clinical practice, and good pharmaco vigilance practice inspection reports; preclinical assessment reports; 2 Murray Lumpkin, Lembit Rago, and Katherine Bond did not fully concur with this recommendation because they believe it still leaves the negotiation, oversight, and finalization of MRAs related to medicines regulation to trade negotiators, rather than empowering medicines regulators to design, develop, conclude, and implement these specific medicines regulatory MRAs on their own.
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Facilitating Information Sharing Among International Medicines Regulators Without a unified platform and a standard format for reporting, the sharing of assessment and inspection reports can be challenging. The committee recognizes that some regulators currently share assessment, inspection, and other reports with other regulators with whom legally authorized appropriate confidentiality arrangements exist.
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Evaluating Public Health Impacts of Recognition and Reliance Arrangements for Medicines Evaluating the impacts of formal and informal recognition and reliance arrangements on public health, on the use of regulatory and industry resources, and on the essential regulatory competencies of regulatory authorities is challenging because of a dearth of frameworks, metrics, and data for use in such evaluations. The texts of existing formal and less formal recognition and reliance arrangements generally fail to incorporate review criteria or frameworks, including specific metrics, by which regulatory authorities, governments, and the broader community could evaluate the arrangements' impacts -- most important, their impacts on public health.
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Eliminating redundant regulatory activities is also essential to having a system that is effective and efficient and able to meet the challenges of the globalized world, in which the products being regulated locally exist today. At present, recognition and reliance arrangements focus on specific classes of medicines (EMA, 2019f; PIC/S, 2019a)
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14 REGULATING MEDICINES IN A GLOBALIZED WORLD It is the committee's view that both formal and informal recognition and reliance arrangements are important regulatory tools for helping regulatory authorities, of all resource levels, address the public health challenges posed by the increasing complexity of medicines and their globalized supply chains. The committee further contends that all medicines regulatory authorities would benefit from increased use of formal and informal recognition and reliance arrangements in conducting activities designed to fulfill their public health mission.
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