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Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators (2019)

Chapter: 4 Stakeholder Views of Recognition and Reliance

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Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 44
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 45
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 46
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 47
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 48
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 49
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 50
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 51
Suggested Citation:"4 Stakeholder Views of Recognition and Reliance." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 52

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

4 Stakeholder Views of Recognition and Reliance This chapter draws heavily on information-gathering sessions conducted by the committee between April and August 2019. In these sessions, current and former regulators and representatives of international harmonization initiatives, industry, and patient advocacy groups gave presentations and answered questions from the committee. These speakers brought numerous challenges, benefits, and opportunities associated with recognition and reliance arrangements to light. Appendix D includes the public meeting agendas where key stakeholders informed the work of this committee by providing views and perspectives that were considered in preparing this report. To the extent possible, points raised by stakeholders about issues related to regulatory challenges and opportunities entailed in recognition and reliance arrangements were compiled into tables presented in this chapter. Content for these tables was supplemented by stakeholder written responses to committee questions, a questionnaire conducted by the World Health Organization (WHO), the published literature, and publicly available government reports. The final section of the chapter presents the committee’s synthesis of the challenges and opportunities thus derived. VIEWS OF STAKEHOLDERS To simply say “the world is changing rapidly” hardly captures the conditions under which medicines regulators are currently working. This was a subtle message expressed by stakeholders throughout all of the committee’s information-gathering work. At the time of this writing, there was uncertainty about the future of the United Kingdom as part of the European Union (EU) and what that would mean for the Medicines and Healthcare Products Regulatory Agency (MHRA) and their colleagues within the European Network. There was also more offshore manufacturing of drugs taking place than ever before. Such a shift requires that more regulators spend time in those countries where the manufacturing is taking place—in 2019, that was China and India. This was not the case just two decades earlier, and whether these two countries will remain the dominant producers of generics a decade from now is yet another uncertainty. Just as the global landscape is changing, so, too are medicines regulatory bodies’ recognition and reliance medicines arrangements, the staff that design them, and the parties involved. Therefore, it must be emphasized that what is presented in this landscaping chapter— PREPUBLICATION COPY: UNCORRECTED PROOFS 43

44 REGULATING MEDICINES IN A GLOBALIZED WORLD supported by additional information in Appendix B—represents a snapshot in time. The committee recognizes that circumstances may have changed even by the time this report is published. In an effort to present relevant material in a constantly changing environment, the committee put forth in this chapter themes supported by examples intended to help guide the discussion of a core set of challenges and opportunities associated with reliance arrangements in the following chapter. Impediments and Challenges Presented in Box 4-1 is a list of impediments that could stall or inhibit communication and collaboration among medicines regulators, thereby preventing any type of meaningful reliance or recognition. This is followed by more targeted messages captured in Box 4-2 about challenges specific to reliance in conducting good manufacturing practice (GMP) inspections, as well as more general challenges that could be faced with any type of reliance used within medicines regulation. BOX 4-1 Impediments to International Communication and Collaboration • Resource constraints, staff turnover, and shifting agency priorities present risks to maximizing information sharing. • The maximal benefits of information sharing will not be realized without the full engagement of participating regulatory authorities and the ability to share full, unredacted reports. • Lack of a shared database with a comprehensive list of registered, uniquely identified active pharmaceutical ingredient (API) manufacturers leads to an inability to anticipate future inspections and therefore to develop a plan for avoiding duplicate inspections. • Lack of a common policy framework for the inspection of shared sites located in third countries limits the ability of regulatory authorities to use other authorities’ inspection reports or to reduce the number of duplicative inspections. • Lack of transparency and visibility of inspection reports that can be shared with and used by lower-resourced regulatory authorities limits reliance capability. SOURCES: Information-gathering sessions; (EMA, 2018a). BOX 4-2 Challenges within Regulatory Reliance Challenges with Reliance on Good Manufacturing Practice (GMP) Inspections Among Well-resourced Regulatory Authorities • Lack of transparency—particular challenge of redacted assessment reports for obtaining information needed to make an informed regulatory decision • Lack of expertise—for highly innovative products, absence of the same level of expertise everywhere now and in the future • Existing differences in regulatory systems • Short-term investment costs—need for up-front and continuous investments of resources to realize benefits: PREPUBLICATION COPY: UNCORRECTED PROOFS

STAKEHOLDER VIEWS OF REGULATION AND RELIANCE 45 − Potential that benefits may not be realized until much later because of the time and resources needed to develop trust, increase knowledge, and achieve convergence − Need to foster an understanding that reliance is not an opportunity to reduce resources used by participating regulatory authorities, but rather an assurance that agencies can avoid duplication and focus their resources on key activities that bring value to the populations they serve (i.e., more efficient use of resources in areas of higher public health risk in which they cannot rely on others) • Lack of secure information technology (IT) systems—lack of secure platforms and procedures for the exchange and management of nonpublic information • Mindset—perception among regulators that reliance reduces autonomy or the belief that reliance is “outsourcing” one’s regulatory responsibilities or accountabilities • Resource misfits—possibility that the decrease in inspections as a result of mutual recognition agreements (MRAs) and other forms of reliance may not translate to an increase in inspections at other sites because of legal restrictions or skillset deficiencies that hinder the movement of inspectors from one site to another − e.g., inability to transfer inspectors with expertise in assessing biotechnology companies to API manufacturing sites because the required expertise is different − similarly, the possibility that staff with expertise in one specialty area may not be motivated to conduct inspections in another • Differing assessment methods—possibility that benefit-to-risk assessments of drugs differ for different partners • Scheduling of collaborative activities Challenges for Any Form of Reliance • Insufficient resources given increasing globalization and global complexities • Differences in regulatory systems • Time required to build trust and confidence • Need for buy-in from key stakeholders, including industry • Need for buy-in from agency reviewers and inspectors who may fear that reliance reduces autonomy, stringency, and job security • Lack of an assessment strategy and metrics for measuring and documenting the success of an agreement or arrangement • Difficulty in objectively measuring outcomes of reliance arrangements • Political challenges outside of medicines regulation SOURCES: World Health Organization (WHO) survey; information-gathering sessions; committee questionnaire; (WHO, 2016d). Benefits and Opportunities The potential contribution of improved decision making to protecting the public health was a clear message from the regulators who provided input for this study, as was the potential to facilitate focusing limited resources on higher-risk issues. It is critically important to understand these points given that ensuring safe and efficacious quality medicines for the health of society is key to the mission of medicines regulatory authorities. For example, greater information-sharing between national regulators and national health systems in the form of early-stage notification could help limit the effects of a public health event caused by a medicine. Currently, Pharmaceutical Inspection Co-operation Scheme (PIC/S) has a procedure for alerting other PREPUBLICATION COPY: UNCORRECTED PROOFS

46 REGULATING MEDICINES IN A GLOBALIZED WORLD authorities about recalls arising from quality defects in medicinal products (PICS, 2017), and WHO has a system for notifying authorities about products found to be substandard or falsified. The system also includes a rapid notification procedure for alerting regulatory authorities of counterfeit or tampered products when urgent action is required to protect public health. The system is dependent on the submission of this information by regulators. According to the regulators who provided input for this study, the system works fairly well, although there is room for improvement. Currently, this system is dependent primarily on external resources, and staffing is limited relative to the system’s mandate. Benefits of Reliance Boxes 4-3 and 4-4 list a number of benefits expressed by respondents regarding reliance in areas other than GMP—medicines approval decisions and international communication and collaboration, respectively. Because so much of the discussion with stakeholders involved MRAs and thus GMP, Box 4-5 lists separately the perceived and real benefits of reliance in the area of GMP based on the sources described previously. It must be emphasized that “perceived” does not mean the benefits are not real; without ex post evaluations; however, it is impossible to know whether the benefits describing greater regulatory efficiency, for example, have actually been attained. Nonetheless, for this particular example, there are indications of expected cost savings from the recently activated US-EC MRA. The European Commission estimates that 100 inspections in the US will be waived by the end of 2019. One inspection takes roughly 16 person-days for the regulatory authority and 160 person-days for industry (at an estimated cost for industry of €352,000 or $US389,493) (Associations, 2018). The benefits listed in Box 4-5 include those associated with a regulatory authority’s relying, to some extent, upon other regulatory agencies for GMP inspection information instead of performing such inspections itself. BOX 4-3 Benefits and Perceived Benefits of Reliance in Medicines Approval Decisions • Regulatory functions are more efficient, with faster review and shorter times to approval. − Faster market availability can improve global public health. − Faster access to medicines is particularly valuable for countries with smaller medicines markets, which generally receive marketing applications later than countries/regions with larger markets. • Sharing of information relating to non-compliance with good clinical practice facilitates the prioritization of internal resources. • For countries that do not conduct inspections abroad, sharing of inspection certificates by partner nations is very valuable to their risk-based regulatory decision-making process. BOX 4-4 Benefits of International Communication and Collaboration • Information can be shared. PREPUBLICATION COPY: UNCORRECTED PROOFS

STAKEHOLDER VIEWS OF REGULATION AND RELIANCE 47 • Trust can be built that elevates confidence in participants. • Transparency and visibility of inspection reports can promote global public health by facilitating better utilization of global inspection resources to focus on higher-risk facilities. • Inspections of previously inspected sites can be deferred. • Regularly scheduled teleconferences can allow for clarifying conversations and more detailed discussions about information shared in inspection reports. • Shared inspection reports can stimulate a desire for joint inspections. • Metrics can be used to determine elements of programs with the highest return on investment. BOX 4-5 Perceived Benefits of Reliance in Good Manufacturing Practice (GMP) Inspections • Increased knowledge and trust between and among regulatory partners − More informed decision making − Joint inspections or observed inspections between mutual recognition agreement (MRA) partners that further increase knowledge of and trust in the other partners − Cooperation and collaboration that increase mutual confidence among GMP inspections field regulators − Sharing of unredacted reports that promotes confidence and trust • Regulatory efficiency (faster review and time to approval) − Early distribution of information on sites identified as GMP noncompliant facilitated − Ability to react quickly in case of rapid alerts • More effective use of resources − Better use of resources through better communication, coordination, and collaboration on sites of common interest − Inspection prioritization and risk-based inspection planning facilitated − Duplication of effort reduced − Resources directed toward manufacturers posing higher risks • Improved quality of reviews/inspections/overall regulatory system − Continuous improvement process for all partners supported by regular, joint audits • Improved global public health − Reallocation of resources that allows for more inspections in third countries of active pharmaceutical ingredient (API) and finished-product manufacturers, ensuring that higher-risk and more total manufacturing sites are inspected − Regularly scheduled discussions on medicine shortages and genetically modified domestic products (GMDPs) − Scientific and procedural deliberation, promoted by the process of achieving reliance and recognition, which likely leads to more informed decision-making and increased patient safety − Inspection of various sites and various product categories using global resources/expertise facilitated by information sharing − Companies’ greater willingness to enter countries with smaller markets and lower purchasing power/return on industry investment • Increased empowerment for smaller regulatory bodies PREPUBLICATION COPY: UNCORRECTED PROOFS

48 REGULATING MEDICINES IN A GLOBALIZED WORLD − Stronger voice for smaller authorities due to reliance collaborations, which may drive convergence and influence developments and guidelines in areas that may be beneficial to these smaller national medicines regulatory authorities − Ability of small-market/small regulatory bodies to maximize their limited resources for achieving the best outcomes while retaining a high degree of regulatory stringency and sovereign decision-making Opportunities for Reliance Whereas benefits represent gains stakeholders perceive as having accrued to them through reliance arrangements, opportunities represent gains they hope to realize through greater reliance in regulatory environments. Box 4-6 lists opportunities identified by stakeholders, both those related specifically to reliance within GMP and those that might go beyond GMP. Discussions of good laboratory practice (GLP) and good clinical practice (GCP) during the committee’s information-gathering sessions were more limited than those of GMP; however, they yielded some outlook that the expansion of the EU-US MRA into areas beyond GMP and batch certification would require political will. Reliance for market authorization—the approval process for medicinal products—would entail sharing of robust data that could be analyzed extensively and completely so that all parties would understand the conclusions reached, which could be difficult for complex medicinal products. However, the situation is different for variations to marketing authorizations of medicines. In this case, the source product is already on the market, so that verification of the risks and benefits for use in patients already exist. The EU system does accept “do-and-tell” whereby companies make some changes after a product is on the market and then inform the regulators. Because this process does not require an assessment, companies are expected to make the necessary changes, and these reports could easily be shared. The situation is different for companies seeking changes in medicines that could modify their risk/benefit profile (e.g., a new indication, a change in dosing, or the addition of new elements in the safety profile). Because this situation requires an assessment, sharing in this space would require political will. Therefore, one way forward would be to start small and evolve toward this outcome. The committee’s focus on GMP does not indicate less importance for GLP or GCP, just relatively less input from stakeholders. This limited input may reflect time restrictions for the committee’s interviews, or a potential gap in the shared work of regulators and a potential opportunity for future reliance arrangements. For example, given that most drug development employs multiregional clinical trials to provide the clinical evidence for marketing authorization, such trials are fairly common for both the United States (US) and the European Union (EU) (EMA, 2009b); therefore, citizens from both jurisdictions may be participants in the same global clinical trial. Both US and EU regulators are required to verify that any study under their jurisdiction—whether in-country or abroad—has followed GCP; was conducted in an ethical manner; and reported accurate and complete data. Given globalization and resource limitations, inspection of all clinical trial sites is virtually impossible. One answer to this challenge is to create greater efficiencies through collaboration in GCP inspections and the exchange of information and inspection reports. Indeed, the EMA and the FDA tested this possibility under their arrangement. The pilot test ended in 2011 and could provide the foundation for future expansion of the recently activated EU-US MRA. Other regulators might also consider exploring the feasibility of reliance in this area. PREPUBLICATION COPY: UNCORRECTED PROOFS

STAKEHOLDER VIEWS OF REGULATION AND RELIANCE 49 BOX 4-6 Opportunities within Reliance for GMP Inspections, as Well as Other Areas • Increased transparency—broadening discussions regarding how reference agencies provide assessment or inspection outcomes (e.g., with respect to redactions, online options, timing efficiency) − Sharing unredacted reports could promote an understanding of reviewed material and the rationale for decisions made. − Sharing unredacted reports could promote confidence and trust. − Relying on a redacted document is usually not possible and often leads to the need to conduct what is a redundant activity to obtain the redacted information. • Harmonized forms—including more discrete data fields or structured-format content to better leverage foreign inspections • Better use of information technology (IT)—providing assessment or inspection outcomes (GMP certificates or inspection reports) • Aligned interests—expanding the scope of an already planned inspection to include another authorities’ areas of interest • Communication and capacity building—building upon work done by international organizations such as the International Coalition of Medicines Regulatory Authorities (ICMRA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) to enhance communication and information sharing on GMP related inspections − Experiences, plans, and best practices among medicines regulators at international workshops on reliance. − Capacity and trust building between regulators could be encouraged through international efforts, e.g., by sharing information on and mutual participation in training activities. − Efforts under way to converge/harmonize inspection processes and reports could be maximized within PIC/S. • Human resource development—identifying the most appropriate experts from an international pool of specialists to conduct inspections aligned with their expertise and/or capacity • Evaluation—establishing and/or sharing metrics for evaluating reliance arrangements − Uptake of reliance pathways could be a useful impact measure for reliance efforts. Opportunities in Other Areas • Proactive sharing of post-market safety data • Establishment of standards for timeliness and minimum information content for posting emergent safety issues or regulatory actions • Standardization of good pharmacovigilance practices, including roles and responsibilities of industry in collecting foreign safety data • Reliance/work-sharing in the area of pharmacovigilance, post-authorization safety, and efficacy monitoring • Access to additional expertise on post-market actions, facilitating responses to issues • Full access to the EU database and thus full access to noncompliance statements, manufacturing licenses, and GMP certificates granted by EudraGMDP database for all EU MRA partners • FDA database for information-sharing under the EU-US MRA PREPUBLICATION COPY: UNCORRECTED PROOFS

50 REGULATING MEDICINES IN A GLOBALIZED WORLD • Verification of GMP compliance of U.S. sites allowed for by Market Authorisation Application SOURCES: WHO survey; information gathering sessions; committee survey; (WHO, 2016d). A Patient-Centered Regulatory Framework Virtually all of the regulators supported the notion that each reliance arrangement either does now or would in the future enable medicines regulatory agencies to improve their efficiency. The regulators also agreed that such arrangements allow them to redirect resources to areas of greater need, although none had data from their agency to support that claim. However, that lack of data may change with the EU-US MRA, as the partners agreed to establish performance indicators with which to demonstrate that implementing the agreement would deliver what had been promised. Information on the specific metrics were not shared with the committee, although a patient advocate from the International Alliance of Patients’ Organizations (IAPO) expressed his interest in what might be measured through the development of a framework that put the patient or consumer at its core. He stressed that in such a framework, patient safety must be paramount. He also highlighted the importance of ensuring faster access to innovations, particularly gene therapy and biotherapeutics, through MRAs or other reliance agreements so that patients who needed them would have access to these innovative medicines. Further, he stressed the need for measuring increased equity, especially in the area of rare diseases, where patients stand to benefit most from increased reliance and access to new medicines. Lastly, his patient-centered framework would include metrics for affordability. He encouraged policy makers to invite patients into debates about regulatory reliance in general and MRAs in particular, emphasizing that patients can offer a real-life perspective that is often missing from policy-driven conversations. He also believes patients could bring a unique view to GMP inspections. Industry Perspective The pharmaceutical industry has benefited from recognition and reliance arrangements, as the collaboration that takes place provides guidelines for industry. In other words, it becomes clearer to all parties what is needed to facilitate market authorization across multiple jurisdictions. There are many agreed-upon technical requirements; however, when there is not a consensus regarding all of the information to be relied upon, the approval process decelerates. Applications for different regulatory authorities have different requirements. These inconsistencies diminish their ability to rely on each other’s work products. As medicines are becoming more complex, the burden of duplicative inspections on industry will increase and the benefit to multiple jurisdictions will be small, as the expertise necessary to effectively examine complex medicines may be limited to a few individuals. Acknowledging the complications associated with initiating and implementing mutual recognition agreements, industry still sees opportunities for MRAs to expand reliance beyond GMP. Product review and first approval inspections are in the limelight; however, a large percentage of industry work occurs in the post-approval and lifecycle management spaces, which are as important to public health as initial approvals. Regulatory authorities have limited capacity, resulting in backlog. Several years may pass before regulatory authorities are able to PREPUBLICATION COPY: UNCORRECTED PROOFS

STAKEHOLDER VIEWS OF REGULATION AND RELIANCE 51 review post-approval changes, hindering multinational distribution. Regulatory reliance has potential utility across medicine lifecycles; examples include registration, inspections, variations, post approval changes, import testing, and lot release. For example, MRAs and reliance arrangements used for post-approval vaccine supply changes would motivate industry because expedited market penetration would be secured. There is an opportunity to reduce the time and effort put forth to keep essential medicines on the market; this parallels regulatory authorities’ goal of reducing supply shortages. SYNTHESIZING THE CHALLENGES AND OPPORTUNITIES Understanding the Value of Reliance Of particular note from the committee’s survey and information-gathering sessions was the importance of helping all stakeholders understand that increased reliance is not an opportunity simply to reduce the resource needs or fees of participating regulatory authorities. Rather, reliance presents opportunities for ensuring that agencies can avoid duplication and focus their resources on key activities that bring value to the populations they serve instead of repeating redundant regulatory tasks. If full trust is built, the result may be greater public health protection. Currently, the overwhelming perception of all the stakeholders whose views were gathered for this study is that greater reliance and recognition in all its forms will, in the short and long terms, strengthen public health across the globe. Financial Implications Among the challenges associated with reliance arrangements, particularly in the case of MRAs, are the costs of setting them up. In most cases, these costs are short term, as they are related to the high degree of administrative and programmatic effort needed to develop, negotiate, and maintain the arrangement. The financial benefits are believed to be realized once the arrangement has been fully implemented. Expected gains in financial and time efficiencies may be modest in the initial phases of trust and knowledge building, but what must be emphasized is the improved decision-making process that is realized when two or more sets of national regulators work together. The stakeholders interviewed by the committee reported their view that this benefit more than compensates for the initial investment of time and resources (see the opportunities listed in Box 4-6). In addition to regulators, these arrangements provide benefits to both industry and consumers. Industry stands to benefit through improved market access, fewer duplicative inspections, and batch retesting waivers upon importation, each of which could translate into greater financial return for the company and indirectly generate public health benefits (e.g., a reduction in redundant regulatory processes expedites the availability of products to populations in need). For patients and consumers, reliance arrangements can provide access to a wider array of medicines at potentially lower cost, as was expressed by the speaker discussing Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) work in recognizing generic approvals of trusted authorities. The overall outcome of these benefits is improved public health protection. PREPUBLICATION COPY: UNCORRECTED PROOFS

52 REGULATING MEDICINES IN A GLOBALIZED WORLD Transparency As was discussed with stakeholders, a potentially more sustainable model than unilateral reliance might involve greater transparency of the work of well- and moderately well-resourced regulatory bodies that are performing at an international level of regulatory oversight. Increased information-sharing along with efforts—such as those of WHO and PIC/S—at capability- and capacity- building among lower-resourced RAs could improve overall global public health while opening the door to better-informed sovereign decision-making in all countries, regardless of national income status. The availability of unredacted reports would allow both well-resourced and lower-resourced regulatory authorities to perform their regulatory activities in an ever- improving manner. One of the issues for lower-resourced regulators is that the medicines may be different, so it is important for them to understand the details provided in a shared report. In some cases, it is not possible to truly rely on the work product of another agency unless the receiving agency obtains a full report. The availability of such unredacted reports would both allow other countries to use these reports to reach their own sovereign decisions on market access and help build needed capabilities in review capacity among regulatory authorities. Public Health Imperative The public health imperative drives some countries to expand their participation in reliance arrangements. In the case of New Zealand, for example, the population is relatively small and thus may be a lower marketing priority for multinational drug companies compared with larger markets. An MRA with Australia, however, has enabled the New Zealand authority to incentivize sponsors to submit for marketing authorization in that country. This mechanism will contribute to bringing new drugs to New Zealand in a timely manner despite the country’s limited market size and population. It should be noted that many countries ensure access to innovative medicines without mutual arrangements—they just unilaterally recognize marketing authorizations issued by other regulatory authorities with the capacity to assess such products. Without such unilateral arrangements, new medicines would not reach many countries in the world. It is speculated that such a process, if built on a foundation of trust, might even be a faster mechanism for approving medicines and getting them to these markets relative to using an MRA. Informal arrangements that facilitate decision making through reliance on the exchange of trusted information include memoranda of understanding, confidentiality commitments, regularly scheduled discussions, and agreed work-sharing programs. In these situations, agencies are gaining access to trusted information that they can then use to decide whether further action on their part is needed prior to making a regulatory decision, or they can make their sovereign regulatory decision informed, in part or in whole, by the information received through these informal arrangements. PREPUBLICATION COPY: UNCORRECTED PROOFS

Next: 5 Removing Impediments and Facilitating Action for Greater Recognition and Reliance Among Regulatory Authorities »
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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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