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On March 31, 2025, the Food and Drug Administration (FDA) of the Philippines released a draft circular titled “Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration”.  The draft circular aims to establish effective recall procedures for authorized health products regulated by the FDA in the Philippine market. The […]

Register your medical device in the Philippines On March 21, 2025, the Food and Drug Administration (FDA) of the Philippines issued FDA Advisory No. 2025-0368, notifying stakeholders of updates to the operating periods of the FDA ePortal system. This change is part of ongoing system maintenance and upgrades aimed at improving online services and supporting

The Food and Drug Administration (FDA) announces that the telephone numbers for the Center for Device Regulation, Radiation Health, and Research (CDRRHR) are suspended from March 4, 2025, to March 28, 2025, or until the completion of necessary roofing installation at their facilities.  Alternative Contact Methods During this period, stakeholders and the public are advised

On March 27, 2025, the FDA, through the Center for Device Regulation, Radiation Health, and Research (CDRRHR), will hold a Virtual Public Consultation to present the proposed Administrative Order (AO) titled “Guidelines for Good Storage and Distribution Practices for Medical Devices.” The consultation will be conducted via Microsoft Teams and will be open to representatives

On March 3, 2025, the Food and Drug Administration (FDA) issued FDA Advisory No. 2025-0139 announcing new email addresses for submitting notifications and reports on health product recalls. Market Authorization Holders (MAHs) must promptly notify the FDA and submit the necessary reports and information to the Food and Drug Action Center (FDAC) at info@fda.gov.ph. Additionally,

On March 3, 2025, the Food and Drug Administration (FDA) issued Advisory No. 2025-0140, reiterating the official contact details and the process for submitting feedback, complaints, and specific concerns. This aims to ensure that all communications are directed to the appropriate departments for timely and proper responses, as referenced in FDA Circular 2020-2026. Feedback and

The Food and Drug Administration (FDA) of the Philippines has announced an extension to the renewal application filing period for the License to Operate (LTO), as detailed in FDA Advisory No. 2025-0095.  Effective February 17, 2025, stakeholders may submit renewal applications 180 days before their LTO expiration date, replacing the previous 90-day requirement. This interim

On February 10, 2025, the Food and Drug Administration (FDA) of the Philippines implemented an Over-the-Counter (OTC) payment system for all FDA applications and transactions. This initiative aims to streamline the payment process, providing greater convenience for stakeholders. Key Highlights 1. OTC Payment Availability and Appointment Requirement OTC payments will be accepted at the FDA

On January 24, 2025, the Food and Drug Administration (FDA) of the Philippines announced the temporary suspension of pre-assessment fees for specific applications, as outlined in FDA Advisory No. 2025-0076. This decision aims to address challenges in implementing Administrative Order (AO) No. 2024-0016, which establishes a new schedule of fees and charges. Key Highlights Temporary