FDA eases registration, extends validity of health product licenses

BIG CHANGES are underway at the Food and Drug Administration (FDA), with new rules designed to streamline the registration process and extend the validity of health product licenses.

The move is part of a broader push to enhance public health safety and is in line with the call of President Ferdinand R. Marcos Jr. to streamline government processes.

In a bold step, the FDA rolled out Administrative Orders (AO) 2024-0015 and AO 2024-0016, aimed at revamping its regulatory landscape.

The new guidelines not only simplify the process of obtaining a License-to-Operate (LTO) for health establishments but also extend the lifespan of these licenses, cutting down the need for frequent renewals.

Likewise, health product licenses can now last up to 12 years, compared to the previous three- to five-year validity.

This gives businesses, especially small and medium enterprises (SMEs), greater stability and less regulatory hassle.

“Sa pamamagitan ng modernisasyon ng regulatory framework, layon ng ahensya na patuloy na suportahan ang paglago ng industriya ng pharmaceuticals, processed foods, cosmetics, at medical devices (Through the modernization of the regulatory framework, the agency aims to continue to support the growth of the pharmaceuticals, processed foods, cosmetics, and medical devices industry),” the FDA said in a statement on Sunday.

With these reforms, the FDA said pre-licensing inspections will continue and remain stringent, to ensure that health establishments meet the highest safety and quality benchmarks before receiving their licenses.

Additionally, the FDA has introduced a new schedule of fees, reflecting the extended license periods and offering clearer guidelines for all stakeholders.

A significant part of the update is the shift to online processing, which promises faster, more efficient applications through a new digital system.

This overhaul, the FDA said, is part of its broader goal to align local regulations with international standards.

It also offers greater opportunities for SMEs to thrive in the rapidly evolving health and wellness market. (Darryl John Esguerra)