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Strengthening regulatory systems globally: a crucial step towards pandemic preparedness and response

Sanjana Mukherjee, Leah Goodman

SUMMARY BOX

  • The COVID-19 pandemic has highlighted significant gaps in global access to drugs, vaccines and other essential medical countermeasures (MCMs), with many low-income and middle-income countries (LMICs) struggling to get their populations vaccinated due to the inequities in vaccine availability and distribution.

  • Lessons learnt from the global response have highlighted the need to establish and strengthen vaccine manufacturing capacities, particularly in LMICs to aid in global health security.

  • Although much emphasis has been placed on establishing, strengthening and diversifying global vaccine manufacturing capacity, few have called for the need to strengthen regulatory systems, which are crucial in overseeing the development and manufacturing of MCMs, as part of overall pandemic preparedness and response efforts.

  • This commentary provides an overview of the key role of medical product regulatory systems during a health emergency crisis, such as pandemics, and provides concrete justifications for the need to simultaneously strengthen national and regional regulatory systems, especially in LMICs, to ensure access to safe, effective and quality MCMs.

  • This commentary aims to highlight the need to include regulatory system strengthening, as part of global and national health security and pandemic preparedness frameworks, to ensure that future responses to pandemics close the inequities in vaccine access and availability observed during the COVID-19 pandemic.

Read the full report on BMJ