Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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4 Stakeholder Views of Recognition and Reliance
4 Stakeholder Views of Recognition and Reliance
Pages 55-68
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From page 55... ...
These speakers brought numerous challenges, benefits, and opportunities associated with recognition and reliance arrangements to light. Appendix D includes the agendas for the public where key stakeholders informed the work of this committee by providing views and perspectives that were considered in preparing this report.
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From page 56... ...
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, this chapter is organized around themes intended to help guide the discussion of a core set of challenges and opportunities associated with reliance arrangements in the following chapter.
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From page 57... ...
• of a shared database with a comprehensive list of registered, uniquely Lack identified active pharmaceutical ingredient manufacturers leads to an inability to anticipate future inspections and therefore to develop a plan for avoiding duplicate inspections. • of a common policy framework for the inspection of shared sites located Lack in third countries limits the ability of regulatory authorities to use other author ities' inspection reports or to reduce the number of duplicative inspections.
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From page 58... ...
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
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From page 59... ...
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.
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From page 60... ...
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 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 -- Scientific and procedural deliberation, promoted by the process of achiev ing recognition and reliance, 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 • -- Stronger voice for smaller authorities due to reliance collaborations, which may drive convergence and influence developments and guidelines in a reas 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 regu latory stringency and sovereign decision making
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From page 61... ...
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
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From page 62... ...
-- 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 -- providing assessment or inspection • outcomes (GMP certificates or inspection reports) Aligned interests -- expanding the scope of an already-planned inspection to • include other authorities' areas of interest Communication and capacity building -- building on work done by interna • tional organizations such as the International Coalition of Medicines Regu latory Authoriies and the Pharmaceutical Inspection Co-operation Scheme t (PIC/S)
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From page 63... ...
Other regulators might also consider exploring the feasibility of reliance in this area. A Patient-Centered Regulatory Framework Virtually all of the regulators who provided input for this study supported the notion that each reliance arrangement either does now or would in the future enable medicines regulatory agencies to improve their efficiency.
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From page 64... ...
Attention focuses on product review and first approval inspections; 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 such that several years may pass before they are able to review post-approval changes, hindering multinational distribution.
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From page 65... ...
The opportunity to reduce the time and effort put forth to keep essential medicines on the market parallels regulatory authorities' goal of reducing supply shortages. SYNTHESIZING THE CHALLENGES AND OPPORTUNITIES Understanding the Value of Reliance Of particular note from the committee-developed supplemental information-gathering questionnaire 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.
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From page 66... ...
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 regulatory authorities could improve overall global public health while opening the door to better-informed sovereign decision making in all countries, regardless of national income status.
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From page 67... ...
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. As discussed previously, 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-upon work-sharing programs.
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