FDA task force binuo sa pagpapabilis ng COVID drugs registration

FDA task force binuo sa pagpapabilis ng COVID drugs registration

February 24, 2023 @ 7:04 PM 4 weeks ago


MANILA, Philippines – Bumuo ang Food and Drug Administration (FDA) ng task force na magpapabilis at magpapadali pa sa pag-apruba at ebalwasyon ng mga COVID-19 drugs sa bansa.

Ayon kay FDA Director General Dr. Samuel Zacarte, ang Taskforce Fleming ay inilunsad upang pabilisin ang probisyon ng ligtas at epektibong gamot kontra COVID-19 sa merkado.

Layon din ani Zacarte ng naturang task force na pabilisin at padaliin ang approval at evaluation ng 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,” saad sa pahayag niya.

“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,” dagdag nito.

Ang EUA ay isang authorization na inilalabas para sa hindi rehistradong mga gamot at bakuna para sa public health emergency katulad ng COVID-19 pandemic.

Ang CPR naman ay ang marketing authorization na pumapayag sa isang produkto na ibenta sa merkado.

“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,” sinabi naman ni Department of Health officer-in-charge Maria Rosario Vergeire.

“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.”

Hanggang nitong Enero 17, 2023, mayroong apat na COVID-19 drug EUA holders ang nagpasa ng application 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,” ani Zacarte. RNT/JGC