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Research Article Open access CC BY 4.0

Roles and Rules of Some Regulatory Agencies around the World during COVID-19 Pandemic

Aseel Bin Sawad, Fatema Turkistani

Journal of Pharmaceutical Research International · pp. 178–187 · Published 1 Jul 2021

10.9734/jpri/2021/v33i34A31838

Abstract

Objective: Collecting and synthesizing relevant data on COVID-19 from official sources of some different regulatory agencies around the world. Methods: The information and actions related to responding to the COVID-19 situation were collected from the websites of some regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada (HC), Swiss Agency for Therapeutic Products (Swissmedic), and the Australian Therapeutic Goods Administration (TGA). Results: All the regulatory agencies help in expediting the development of COVID-19 treatments and medical devices. These agencies also developed an international regulatory collaboration to develop cure models for the pandemic. While some of the agencies conduct the COVID-19 testing, like the US FDA, the others do not. The agencies also differ in their approaches towards resolving the pandemic. FDA and EMA are more aggressive in a way that they prioritize more testing and hospitalization coverage. However, as of the 22nd of June 2021, the FDA authorized the highest number (388) of diagnostic COVID-19 test kits followed by TGA (128), and EMA (88). Conclusions: Although the regulatory agencies differ in their approaches towards resolving pandemic COVID-19, all regulatory agencies help in expediting the development of COVID-19 treatments and medical devices.

FDA EMA Health Canada swissmedic therapeutic goods Administration COVID

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