FDA creates task force to fast track COVID-19 drugs registration
The Food and Drug Administration (FDA) has created a task force to fast track and streamline the approval and evaluation of COVID-19 drugs in the country.
FDA Director General Dr. Samuel Zacarte said Taskforce Fleming was launched to fast track the provision of “safe and effective” COVID-19 drugs in the market.
Zacarte said the task force aims to streamline the approval and evaluation of COVID-19 drugs “without compromising efficacy, quality, and safety.”
“Previously, emergency use authorizations (EUAs) were issued for COVID-19 drugs and vaccines subject to certain conditions,” he said in a statement.
“Now, with the introduction of Taskforce Fleming, COVID-19 drugs that will be approved and issued with Certificates of Product Registration (CPR) will be readily-accessible to the general public in FDA-licensed drug establishments with the assurance that any post-market issues will be addressed through more rigorous surveillance and pharmacovigilance,” he added.
EUA is an authorization issued for unregistered drugs and vaccines in a public health emergency such as the COVID-19 pandemic. A CPR, on the other hand, is a marketing authorization that would allow the sale of products in the market.
Meanwhile, Department of Health (DOH) officer-in-charge Maria Rosario Vergiere welcomed the initiatives of the FDA.
“We welcome FDA's efforts to institutionalize this initiative that will focus on processing the registration of COVID-19 drugs and to make them available commercially,” Vergeire said.
“We also encourage manufacturers or suppliers to transition their COVID-19 EUs into a product registration as this will be a good start to our economic recovery.”
As of January 17, 2023, at least four COVID-19 drug EUA holders have submitted applications for registration, the FDA said.
Published February 27, 2023
