Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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2 The Job of Medicines Regulators in Today's World
2 The Job of Medicines Regulators in Today's World
Pages 23-36
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From page 23... ...
Before delving into various aspects of cooperation for the regulation of medicines, it is important to understand some of the core functions of RAs and the environment in which they now work, one that has seen unprecedented changes due primarily to advances in technology and applications stemming from the Human Genome Project (Lesko and Woodcock, 2004)
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From page 24... ...
Quality control testing can also occur post-marketing along with product quality monitoring and surveillance, safety/pharmacovigilance, and enforcement of pharmaceutical laws and regulations. Good Regulatory Practices for Cooperation The Organisation for Economic Co-operation and Development (OECD)
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From page 25... ...
defines recognition as the routine acceptance of another RA's -- or other trusted institution's -- regulatory decisions based on the work products of that other agency. In contrast, reliance is defined as being more flexible, giving an RA in one jurisdiction the option of taking into account work products (e.g., inspection reports, scientific assessment reports, joint assessment reports produced together with another RA)
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From page 26... ...
Reliance: The act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to (i.e., totally or partially rely on work products by) another regulatory authority or trusted institution in reaching its own decision.
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From page 27... ...
Because RAs involved in horizontal recognition and reliance arrangements are of similar or comparable capacities, the collaboration is usually mutual and "trust" here means that one agency has concluded that the other does as good a job as its own reviewers or inspectors. Recognition and Reliance Among Lower-Resourced Regulatory Authorities A lower-resourced RA can base its decisions on the work products of well-resourced, trusted RAs.
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From page 28... ...
Each state lacks the resources and capacity necessary to fully conduct medicines regulation on its own so the CRS uses a regional reliance mechanism -- relying on trusted RAs within the Pan American Health Organization, the European Union (EU) , and WHO prequalification -- to help inform its decisions about which medicines to recommend for regional market authorization (PAHO, 2019b)
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From page 29... ...
FIGURE 2-2 Trust components needed for reliance. NOTE: COI = conflict of interest; PIC/S = Pharmaceutical Inspection Co-operation Scheme; RA = regulatory authority; WHO = 29 World Health Organization.
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. Some formal collaborative activities include what might be considered less formal interactions through regularly scheduled calls and meetings that build trust between regulators as they move toward greater confidence levels for reliance.
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From page 31... ...
Mutual Recognition Agreements While reliance arrangements promote the sharing of information and facilitate fewer redundant inspections and other regulatory activities, MRAs allow agencies not just to rely on each other's work products but also to recognize them as equal to the work of their own reviewers or inspectors. For the EU, MRAs allow for reliance on the GMP inspection systems of other RAs, information sharing based on inspections and quality, and the waiving of batch testing of those products imported into EU territories.
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From page 32... ...
. Regulatory reliance may be facilitated by having RAs converge more than diverge on such matters as procedures and common formats for reports and forms, as appropriate, and as supported by international organizations such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and by bringing regulators together for various collaborative and cooperative efforts (see Box 2-3 for a summary of harmonization, convergence, and reliance efforts through international organizations)
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From page 33... ...
• International Coalition of Medicines Regulatory Authorities (ICMRA) : CMRA is a voluntary, executive-level, strategic coordinating, advocacy and I leadership entity of regulatory authorities that work together to address current and emerging human medicine regulatory and safety challenges globally, pro vide direction for areas and activities common to many regulatory authorities' missions, identify areas for potential synergies, and wherever possible, lever age existing initiatives/enablers and resources.
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From page 34... ...
. Numerous reasons were suggested for the delay, including "failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries" (Ahonkhai et al., 2016, p.
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From page 35... ...
. These reports exclude confidential proprietary information, and in the case of WHO, are posted only on its website with the manufacturer's approval.
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