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菲律宾对题为“规定仅用于出口的药品和活性药物成分注册规则和条例”的第2024-0012号行政命令的修正案

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世界贸易组织	G/TBT/N/PHL/366 2026-04-28 26-3166

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：阿蒂。Paolo S.Teston卫生部食品药品监督管理局局长
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：对题为“规定仅用于出口的药品和活性药物成分注册规则和条例”的第2024-0012号行政命令的修正案；语言：英语页数：2 链接网址：
6.	内容简述：该政策修订了第2024-0012号行政命令（AO）中规定的仅出口注册证书的有效期。初始注册的有效期为三（3）年或六（6）年，而续期注册的有效期为三（3）年、六（6）年、九（9）年或十二（12）年，由申请人自行决定。
7.	目标与理由：第3720号共和国法案（RA），也称为“食品、药品和器械以及化妆品法案”，经1987年第175号行政命令（EO）修订，并经第9711号RA或“2009年食品和药物管理局（FDA）法案”进一步修订，要求FDA在任何健康产品的制造、进口、出口、销售、要约销售、分销、转让、非消费者使用、测试、促销、广告或赞助之前，通过发布适当的授权来监管健康产品,根据这一授权，发布了题为“规定仅用于出口的药品和活性药物成分注册的规则和条例”的AO第2024-0012号，以建立管理药品和活性药物成分注册的监管框架,仅用于出口的药物成分（API）,为确保这一框架继续适应不断变化的监管需求和运营现实，特此修订有关仅出口证书有效性的规定,
8.	相关文件： RA 3720，经第175 s号行政命令修订。1987年：《食品、药品和器械以及化妆品法》RA No.9711：《2009年食品和药物管理局(FDA)法》AO No.2024-0012：《规定仅用于出口的药品和活性药物成分注册的规则和条例》
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6月5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3F贸易和工业大楼361 Sen.Gil Puyat AvenueMakati City Philippines 1200 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_02255_00_e.pdf https：//www.fda.gov.ph/draft-for-comments-amendment-to-administrative-order-no-2024-0012-titled-prescribing-the-rules-and-regulations-on-the-registration-of-pharmaceutical-products-and-active-pharmaceutical-products-and-active-pharmaceutical-ing/Dr.Charmaine Ann M.Rabago负责人、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.od@fda.gov.ph、cdrr.sds@fda.gov.ph



	G/TBT/N/PHL/366
	28 April 2026
(26-3166)
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: Atty. Paolo S. Teston Director General Food and Drug Administration DEPARTMENT OF HEALTH
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): Amendment to Administrative Order No. 2024-0012 Titled "Prescribing the Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended Solely for Export"; (2 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_02255_00_e.pdf https://www.fda.gov.ph/draft-for-comments-amendment-to-administrative-order-no-2024-0012-titled-prescribing-the-rules-and-regulations-on-the-registration-of-pharmaceutical-products-and-active-pharmaceutical-ing/ 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.od@fda.gov.ph, cdrr.sds@fda.gov.ph
6.	Description of content: The policy amends the validity period of the Export-Only Registration Certificate as prescribed in Administrative Order (AO) No. 2024-0012. Initial registration shall be valid for three (3) or six (6) years, while renewal registration shall be valid for three (3), six (6), nine (9), or twelve (12) years, at the discretion of the applicant.
7.	Objective and rationale, including the nature of urgent problems where applicable: Republic Act (RA) No. 3720, otherwise known as "Foods, Drugs and Devices, and Cosmetics Act", as amended by Executive Order (EO) No. 175 series of 1987, and further amended by RA No. 9711 or the "Food and Drug Administration (FDA) Act of 2009", mandate the FDA to regulate health products through the issuance of appropriate authorizations prior to the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, testing, promotion, advertisement, or sponsorship of any health product. In line with this mandate, AO No. 2024-0012 Titled "Prescribing the Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended Solely for Export" was issued to establish the regulatory framework governing the registration of pharmaceutical product and active pharmaceutical ingredients (APIs) solely intended for export. To ensure that this framework remains responsive to evolving regulatory needs and operational realities, the provision relating to the validity of the Export-Only Certificate is hereby amended.
8.	Relevant documents: RA 3720, as amended by EO No. 175 s. 1987: "Foods, Drugs and Devices, and Cosmetics Act" RA No. 9711: "Food and Drug Administration (FDA) Act of 2009" AO No. 2024-0012: "Prescribing the Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended Solely for Export"
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: 5 June 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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