11 manufacturers of self-administered antigen test kits seek FDA approval

MANILA, Philippines — Eleven manufacturers of self-administered COVID-19 test kits have applied for the approval of their products before the Food and Drug Administration (FDA), the Department of Health (DOH) said Tuesday.

“Mayroon na pong nag-apply sa Food and Drug Administration ng mga home administered kits. Ito po ay mga manufacturers, 11 na po ang nakapag apply,” Health Undersecretary Maria Rosario Vergeire said in a media briefing.

(There are 11 manufacturers of home administered kits that have applied before the Food and Drug Administration.)

Vergeire said the products will be approved if they pass the standards of the FDA and the Research Institute for Tropical Medicine (RITM).

“Based on the load of work of RITM, although they were instructed to prioritize this, it will take them about two days or 48 hours to finish a performance evaluation for a specific kit,” she said.

“Within seven to ten days lalabas ang registration o certification nitong mga home administered test kits na papasa sa standards ng RITM at tsaka ng FDA,” she added.

(Within seven to ten days, the registration or certification of these home administered test kits that passed the standards of RITM and FDA will be issued.)

Vergeire said the government is also set to review the price cap for COVID-19 antigen tests aside from RT-PCR test kits.

je