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Review
. 2020 Oct;108(4):703-705.
doi: 10.1002/cpt.1932. Epub 2020 Jul 4.

Pandemic Best Regulatory Practices: An Urgent Need in the COVID-19 Pandemic

Murray M Lumpkin  1 , John C W Lim  2   3
Affiliations
Review

Pandemic Best Regulatory Practices: An Urgent Need in the COVID-19 Pandemic

Murray M Lumpkin et al. Clin Pharmacol Ther. 2020 Oct.

Abstract

As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID-19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk-1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight "pandemic best regulatory practices." These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency-thus contributing to ending this pandemic as quickly, effectively, and safely as possible.

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Conflict of interest statement

The authors declared no competing interests for this work.

References

    1. Eichler, H.-G. et al. Clinical trials for COVID‐19: can we better use the short window of opportunity? Clin. Pharm. Ther. 180, 730–733 (2020). - PMC - PubMed
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    1. International Medical Device Regulators Forum <http://www.imdrf.org/>. Accessed May 21, 2020.
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    1. World Health Organization . International Conference of Drug Regulatory Authorities <https://www.who.int/medic​ines/areas​/quali​ty_safet​y/regul​ation_legis...>. Accessed May 21, 2020.

MeSH terms