Regulatory flexibilities and access to COVID-19 vaccines during the pandemic in Bhutan

Dawa Tshering; Pelden Chejor

doi:10.1016/j.rcsop.2022.100156

Regulatory flexibilities and access to COVID-19 vaccines during the pandemic in Bhutan

Explor Res Clin Soc Pharm. 2022 Sep:7:100156. doi: 10.1016/j.rcsop.2022.100156. Epub 2022 Jul 15.

Authors

Dawa Tshering¹, Pelden Chejor²

Affiliations

¹ Drug Regulatory Authority, Post Box 1556, Thimphu, Bhutan.
² Center for Research in Aged Care, Edith Cowan University, 270 Joondalup Dr, Joondalup, WA 6027, Australia.

Abstract

Coronavirus disease 2019 (COVID-19) is rapidly evolving with millions of cases and death reported globally. The first-ever case of COVID-19 in Bhutan was confirmed on 5 March 2020 in a 76-year-old American tourist. The national regulatory authorities have implemented varying degrees of regulatory flexibilities to prevent unnecessary death by ensuring timely access to medical products and technologies during the pandemic. The Drug Regulatory Authority of Bhutan, as a national medicines regulatory agency responsible for ensuring the quality of medical products has implemented several regulatory mechanisms to ensure access to medical products including COVID-19 vaccines during the pandemic. In this commentary, we discuss the regulatory flexibilities that ensured access to medical products and COVID-19 vaccines during the pandemic.

Keywords: COVID-19 pandemic; Drug regulatory authority; Emergency use authorization; Medical products; Vaccines.