Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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5 Removing Impediments and Facilitating Action for Greater Recognition and Reliance Among Regulatory Authorities
5 Removing Impediments and Facilitating Action for Greater Recognition and Reliance Among Regulatory Authorities
Pages 69-88
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From page 69... ...
Accordingly, regulators, regardless of human, technical, and financial resources, should make increased use of reliance and cooperation with other trusted regulators, as no regulator has the resources it needs to meet all of its public health responsibilities. • Impediments to regulators entering into and using such informal and formal recognition and reliance arrangements to help them 69
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From page 70... ...
Additionally, given the rapid movement of people and illnesses across borders in today's world, it is similarly safe to say that public health is a global concern and that all regulators, regardless of size or financial resources, exercise their responsibilities within that global public health framework as part of a larger global regulatory enterprise. How regulatory authorities carry out their missions and structure their regulatory cooperation activities is often a function of human and financial resources.
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From page 71... ...
Opportunity It is the responsibility of industry to monitor its own, globalized supply chains and to correct and report any issues that may arise during manufacturing and production processes. Regulatory agencies are expected to ensure that industry takes the proper steps so that people within their jurisdiction have access to safe and effective quality medicines; good manufacturing practice (GMP)
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From page 72... ...
. Opportunity: In confronting the global challenges of medicines regula tion, cooperation and collaboration among regulators offer opportuni ties 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 arrange ments such as MRAs and other, less formal reliance arrangements.
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From page 73... ...
Each of these stakeholder groups has a role to play in supporting efforts to enhance cooperation between and 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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From page 74... ...
• 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 very 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 leverage 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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From page 75... ...
Opportunity The most formal information-sharing arrangements between medicines regulators have typically been legally binding MRAs, in which one agency recognizes the work and actions of another as equivalent to its own and something it can rely on. In discussions regarding MRAs and other regulatory reliance arrangements, it is essential that the goals of international commerce and freer trade not be pursued at the expense of improved public health for either party involved.
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From page 76... ...
Allowing regulators to develop such arrangements would enhance global public health. 1 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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From page 77... ...
reliance arrangements have the potential to improve public health protection through increased sharing of information and the reallocation of resources for the inspection of drug manufacturing facilities with potentially higher public health risks (FDA, 2019b)
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From page 78... ...
. MRAs and other reliance arrangements among trusted regulatory authorities would allow them to avoid duplicative inspections at sites demonstrating compliant GMP and to focus on sites that have not been inspected or that are in need of re-nspection i following non ompliance.
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From page 79... ...
FACILITATING INFORMATION SHARING AMONG INTERNATIONAL MEDICINES REGULATORS Challenge The questions of how, when, if, and to what extent regulatory agencies can share commercial confidential information and trade secrets is a very real concern for industry. Companies do not want their trade secrets (e.g.,
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From page 80... ...
, and regulatory partners wishing to rely on FDA inspection reports have been unable to do so because of these numerous redactions (Schwartz, 2017)
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From page 81... ...
Third, the information gained by reviewing the findings of others' inspection reports allows regulators to make more informed sovereign decisions, most often without having to use their own limited resources to perform what would be a redundant inspection exercise. Each of these benefits, based on greater transparency and completeness of inspection reports, helps strengthen the global public health infrastructure for safe and effective quality medicines through learning and greater insights into what manufacturers are actually doing.
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From page 82... ...
Regulators must balance a desire to provide other regulators with access to unredacted inspection reports against the need to honor the legal requirements for protecting "trade secrets and commercial or financial information which is privileged or confidential."4 Opportunity: Increasing information sharing and the transparency of each other's regulatory activities can facilitate medicines regulators' more efficient resource allocation and decision making. Making com plete/unredacted assessment and inspection information available to other regulators will enable more equitable access to quality regulatory information for a greater number of regulatory authorities to address global public health needs.
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From page 83... ...
The committee believes that to best meet the public health goals of reliance arrangements, an opportunity exists for FDA and Congress to ensure that current redaction practices optimize information sharing. To this end, FDA and Congress could reevaluate whether existing confidentiality restric
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From page 84... ...
EVALUATING PUBLIC HEALTH IMPACTS OF RECOGNITION AND RELIANCE ARRANGEMENTS FOR MEDICINES REGULATION Challenge Recognition and reliance arrangements have been operational over varied timeframes, some for as long as two decades, and in a variety of different contexts. Accordingly, they could offer lessons as to what the most successful such arrangements have in common and their short-, medium-, and long-term benefits.
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From page 85... ...
The texts of existing formal and less formal reliance arrangements fail to incorporate review criteria or frameworks, including specific metrics, by which regulatory authorities and the broader community could evaluate the arrangements' public health impacts. Opportunity The Government Performance and Results Act of 1993 (Pub.
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From page 86... ...
The committee's interviews with regulators pointed to potential outcome measures that would reflect the public health benefits of recognition and reliance arrangements, although those benefits are not yet being measured. These potential outcome measures included number of inspections in higher-risk areas, number of sites inspected for the first time, redeployment of staff to higher-risk product areas and regions, and rapid response to alerts and incidents involving GMP noncompliance.
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From page 87... ...
The report also applauded FDA's progress in responding to present-day medicines regulatory challenges through a variety of interventions that included signing the MRA with the European Commission. As discussed earlier, this MRA, which became fully functional in July 2019, includes provisions7 for formally accepting third-country inspections conducted by the other region's regulatory bodies.8 That is, under the current MRA, the United States and the EU could accept inspec 6 "FDA defines a collaborative action as concrete regulatory and public health actions, or initiatives that contribute toward supporting OIP objectives and outcomes" (GAO, 2016, p.
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From page 88... ...
Recommendation 6: When formal and informal recognition and reli ance arrangements are being developed, the regulatory authorities involved should co-create a results framework with clear indicators/ metrics and processes for monitoring and measuring the arrangements' results and impacts to enhance understanding of their public health and other benefits and associated regulatory efficiencies, and enable benefit/ risk and cost/benefit analysis of the arrangements over time.
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