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Philippines FDA Finalizes Revisions to LTO Guidelines

Compared to its predecessor, the newly released AO No. 2024-0015 refines LTO application procedures, modifies the requirements and validities for LTO applications, strengthens the requirements for the Qualified Person, and details FDA’s decision grounds for LTO applications and issued LTOs.

On November 27, 2024, Philippines Food and Drug Administration (FDA) issued the Administrative Order (AO) No. 2024-0015, titled Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017. It shall take effect 15 days after its publication in the Official Gazette or in a newspaper of general circulation, and upon filing at the Office of the National Administrative Register (ONAR) of the UP Law Center, replacing AO No. 2020-0017.1

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