The Food and Drug Administration (FDA) recently created a task force in order to fast-track and streamline the approval, as well as the evaluation of COVID-19 drugs in the country.
In a statement, FDA Director General Dr. Samuel Zacarte said “Task Force 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.
“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.
As of January 17, 2023, at least four COVID-19 drug EUA holders have submitted applications for registration, the FDA said.
“We encourage the pharmaceutical industry to complete the necessary requirements for registration and apply for the issuance of CPR or a marketing authorization in support of this Taskforce Fleming. The FDA is supportive of the government’s thrust to full economic recovery,” Zacarte said.
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,” she said.