WTO notification · TBT
PhilippinesProposed measure, may since have been adopted
Official title
Content of License to Operate (LTO) issued by the Food and Drug Administration for Pharmaceutical Establishments
The Philippines notified this proposed TBT measure to the WTO on 8 April 2026. The comment period closed on 24 April 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Pharmaceutics
The comment period closed on 24 April 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/PHL/365; it can take them up with the Philippines.
Find your country's enquiry point on WTO ePing (opens in a new tab)Pursuant to Administrative Order (A.O.) No. 2024-0015, '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 A.O. No. 2020-0017,' and as part of its commitment to continuous quality improvement, the Food and Drug Administration (FDA) continues to strengthen institutional efficiency through the implementation of a robust Quality Management System (QMS). This initiative supports the FDA’s ongoing efforts to accede to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and be a World Health Organization (WHO) Listed Authority (WLA). These international standards strongly recommend having a standardized format and content for authorizations on pharmaceutical manufacturing. By aligning as well the authorization issued for other regulated pharmaceutical establishments, the FDA ensures consistency, transparency, and proper monitoring across all issued licenses. This also facilitates compliance with internationally accepted practices and promotes ease of verification by both local and foreign regulatory bodies. In line with these initiatives, the FDA issues this Circular to establish the contents of License to Operate (LTO) issued by the FDA for pharmaceutical establishments.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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Expodite matches each notification to the markets you export to and the HS codes of your products, and puts the ones that concern you in your Updates centre, with the date comments close.