FDA sets up task force to fast track registration of Covid-19 meds
The Food and Drug Administration (FDA) has formed a task force to hasten and streamline the approval and evaluation of medicines for Covid-19.
The Task Force Fleming was launched to "fast track the provision of safe and effective Covid-19 drugs in the market," said FDA Director-General Samuel Zacate in a statement.
This also "seeks to streamline the approval and evaluation of Covid-19 drugs without compromising efficacy, quality, and safety," he said.
"Previously, emergency use authorizations (EUAs) were issued for Covid-19 drugs and vaccines subject to certain conditions," said Zacate.
"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," he noted.
To note, an EUA is being issued by the FDA for unregistered drugs and vaccines in a public health emergency. On the other hand, a CPR is being issued to manufacturers to allow the market and selling of their products commercially.
There are currently two Covid-19 drugs with approved CPR by the FDA—-these are ronapreve and remdesivir, the Department of Health (DOH) said.
Meanwhile, four other Covid-19 EUA holders have submitted applications for registration, the FDA said.
Zacate encouraged drugmakers to apply for a CPR for their Covid-19 drugs.
“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," he said.
DOH Officer-in-Charge Maria Rosario Vergeire also made the same call for drugmakers.
“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," she said.
"We also encourage manufacturers or suppliers to transition their Covid-19 EUAs into a product registration as this will be a good start to our economic recovery,” she added.
To note, the FDA's Task Force Fleming was named after British physician Dr. Alexander Fleming who is well-known for discovering the antibiotic drug called “Penicillin.”