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菲律宾食品药品监督管理局为制药机构颁发的经营许可证（LTO）的内容

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世界贸易组织	G/TBT/N/PHL/365 2026-04-08 26-2737

技术性贸易壁垒	原文：英语

通报

以下通报根据TBT协定第10.6条分发

1.	通报成员: 菲律宾如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
2.	负责机构： Charmaine Ann M.Rabago博士主管、IV药品监管与研究中心主任食品药品监督管理局卫生部电子邮件：cdrr@fda.gov.ph、cdrr.sds@fda.gov.phwww.fda.gov.ph
3.	通报依据条款： [X] 2.9.2 [ ] 2.10.1 [ ] 5.6.2 [ ] 5.7.1 [ ] 3.2 [ ] 7.2 通报依据的条款其他：
4.	覆盖的产品：制药（ICS编码：11,120） HS编码：30　　ICS编码：11.120
5.	通报标题：食品药品监督管理局为制药机构颁发的经营许可证（LTO）的内容；语言：英语页数：4 链接网址：
6.	内容简述：根据第2024-0015号行政命令（A.O.）“规定了向食品药品监督管理局申请所涵盖保健品机构经营许可证的规则、要求和程序，废除第2020-0017号行政命令”，作为其持续质量改进承诺的一部分，食品药品监督管理局（FDA）继续通过实施强大的质量管理体系（QMS）来加强机构效率。这一举措支持FDA正在进行的加入药品检验合作计划(PIC/S)并成为世界卫生组织(WHO)列出的机构(WLA)的努力。这些国际标准强烈建议药品生产授权采用标准化的格式和内容。通过调整为其他受监管制药机构颁发的授权，FDA确保了所有颁发许可证的一致性、透明度和适当监控。这也有助于遵守国际公认的做法，并促进本地和外国监管机构的核查。根据这些举措，FDA发布了本通知，以确定FDA为制药机构颁发的经营许可证（LTO）的内容。
7.	目标与理由：本通知旨在建立反映当前监管要求的制药企业经营许可证（LTO）的标准化和更新内容，提高其中所示信息的清晰度和透明度，并确保符合A.O.2024-0015号及相关发行,
8.	相关文件：第2024-0015号行政命令
9.	拟批准日期：待定拟生效日期：待定
10.	意见反馈截止日期： 2026年4月24日；指定处理有关通报的意见的机构或当局的联系方式： Neil P.Catajay先生菲律宾标准局贸易和工业部贸易和工业大楼 3F 361 Sen.Gil Puyat Avenue Makati City Philippines1200 电话：(632)751 470 0；(632)7913128 电子邮件：bps@dti.gov.ph 网站：http://www.bps.dti.gov.ph
11.	文本可从以下机构得到： [ ] 国家通报机构 [X] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供): https://members.wto.org/crnattachments/2026/TBT/PHL/26_01947_00_e.pdf https：//www.fda.gov.ph/draft-for-comments-content-of-license-to-operate-lto-issued-by-the-food-and-drug-administration-for-pharmaceutical-establiments/



	G/TBT/N/PHL/365
	8 April 2026
(26-2737)
Committee on Technical Barriers to Trade		Original: English

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

1.	Notifying Member: PHILIPPINES If applicable, name of local government involved (Articles 3.2 and 7.2):
2.	Agency responsible: Dr. Charmaine Ann M. Rabago Officer-in-Charge, Director IV Center for Drug Regulation and Research Food and Drug Administration DEPARTMENT OF HEALTH Email: cdrr@fda.gov.ph, cdrr.sds@fda.gov.ph www.fda.gov.ph
3.	Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:
4.	Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Pharmaceutics (ICS code(s): 11.120)
5.	Details of notified document(s) (title, number of pages and languages, means of access): Content of License to Operate (LTO) issued by the Food and Drug Administration for Pharmaceutical Establishments; (4 page(s), in English) Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request: https://members.wto.org/crnattachments/2026/TBT/PHL/26_01947_00_e.pdf https://www.fda.gov.ph/draft-for-comments-content-of-license-to-operate-lto-issued-by-the-food-and-drug-administration-for-pharmaceutical-establishments/
6.	Description of content: 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.
7.	Objective and rationale, including the nature of urgent problems where applicable: This Circular aims to establish a standardized and updated contents of License to Operate (LTO) of pharmaceutical establishments that reflects current regulatory requirements, improves the clarity and transparency of information indicated therein, and ensures compliance with A.O. No. 2024-0015 and related issuances.
8.	Relevant documents: Administrative Order (A.O.) No. 2024-0015
9.	Proposed date of adoption: To be determined Proposed date of entry into force: To be determined
10.	Provision of comments Final date for comments: 24 April 2026 [ ] 60 days from notification Contact details of agency or authority designated to handle comments regarding the notification: Mr. Neil P. Catajay Director Bureau of Philippine Standards Department of Trade and Industry 3F Trade and Industry Building 361 Sen. Gil Puyat Avenue Makati City Philippines 1200 Tel: (632) 751 4700; (632) 7913128 Email: bps@dti.gov.ph Website: http://www.bps.dti.gov.ph

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