The Philippine Food and Drug Administration (FDA), an attached agency of the Department of Health (DOH), launched Taskforce Fleming, a specialized program to fast track the provision of safe and effective COVID-19 drugs in the market.
The FDA, led by Director General Dr. Samuel A. Zacate, aims to create a specialized team to shift the focus of the current administration from COVID-19 crisis management to a more robust recovery of the national economy and to further the purpose and objectives of Taskforce Fleming. The said program also seeks 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. 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.
“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. 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,” said DOH Officer-in-Charge Dr. Maria Rosario Singh-Vergeire.
On 17 January 2023, Casirivimab Imdevimab (Ronapreve) 120 mg/mL Concentrate for Solution for Injection (SC)/Infusion (IV) has been registered under Monitored Release and four (4) COVID-19 drug EUA holders have submitted applications for registration.
“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”, Director General Zacate concluded.