FDA pushes online OTC drug registration to cut backlog

A PLANNED shift to online filing for over-the-counter (OTC) medicines is expected to ease processing bottlenecks at the Food and Drug Administration (FDA), which is grappling with thousands of pending applications at its drug regulation unit.

- BLESS AUBREY OGERIO

FDA Director General Paolo Teston said the agency is preparing to transition the Center for Drug Regulation and Research (CDRR) from manual to online submissions for generic OTC medicines within the first quarter of 2026.

“Everything right now at the CDRR is being filed manually. We want to improve turnaround time for registration of over-the-counter medicines,” Teston told reporters on the sidelines of the European Chamber of Commerce of the Philippines (ECCP) luncheon in Makati City.

Under existing rules, fully compliant applications are supposed to be processed within the period prescribed under the Anti-Red Tape Act, which he said is around 180 days.