The Food and Drug Administration (FDA) informs its stakeholders that effective immediately, all applications for renewal of License to Operate (LTO) shall revert to the prescribed renewal period of ninety (90) calendar days prior to its expiration, following Administrative Order 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”.
In line with this, FDA Advisory No. 2025-0095 entitled “Interim Extension of Renewal Application Period of License to Operate (LTO) Prior to Expiration of Validity” is hereby lifted. All previous guidelines and instructions outlined in the advisory are no longer in effect.
Refer to the advisory for complete instructions:
Effectivity
- FDA announces that effective immediately, all LTO renewal applications shall follow the prescribed period of ninety (90) calendar days prior to expiration.
- This follows Administrative Order 2024-0015, repealing previous provisions under Administrative Order No. 2020-0017.
- FDA Advisory No. 2025-0095 on the interim extension of the renewal period is officially lifted, and its guidelines are no longer in effect.
Implications to Clients
Since FDA Advisory No. 2025-0095-A is officially lifted, all establishments licensed by the FDA must now submit their LTO renewal applications no earlier than ninety (90) calendar days before expiration, as prescribed by Administrative Order No. 2024-0015.
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