Europe-PH News

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.

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.

He noted, however, that timelines vary depending on the completeness of submissions and the technical evaluation required. “Evaluation of pharmaceutical product requires a technical evaluation. It’s critical,” Teston said.

“Imagine you’ll be consuming a product that is meant to heal you and if it doesn’t go through that kind of process, you will not get the results that you’re expecting from the pharmaceutical product. So it really takes time,” he added.

The online portal is part of a broader effort to address a backlog of around 16,000 to 17,000 applications at the CDRR.

Based on internal projections, clearing the pending applications could take up to 2028 if current capacity remains unchanged.

“It will take us 33 months in our projection,” Teston said, explaining that the estimate was based on the output capacity of each evaluator.

According to him, the computation factored in roughly 254,000 applications processed annually and 248 evaluators assigned to review them.

To ease the workload, the FDA is exploring the use of automated systems for low-risk products. “For low-risk products, probably, it will be done by the program,” he said, adding that automation could help free up human evaluators for more complex applications.

The FDA chief clarified that the goal is not to issue approvals instantly. “I’m not saying that the approval is real-time. We don’t want that type of service unless, of course, it’s ultra-low risk,” he said.

He added, “What I’m saying is, there will be a relevant improvement in the processing of applications, in particular OTC generics.”

While the agency is pushing for faster implementation, adjustments in the timeline may still occur. “Everything is urgent to me as Director General. I want everything to be fast. But within the year, sure,” he said.

The FDA’s reforms come amid calls from industry groups for more predictable and efficient regulatory processes, particularly for widely used medicines.