G/TBT/N/PHL/305  
12 July 2023  
(23-4699) Page: 1/3 
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 (Article 3.2 and 7.2):   
2. Agency responsible:   
DR. SAMUEL A. ZACATE  
Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notifi cation shall be indicated if different from above:   
Jesusa Joyce N. Cirunay, RPh  
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  ; bps@dti.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 or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Health 
care technology (ICS code(s): 11); Food technology (ICS code(s): 67); Chemical 
technology (ICS code(s): 71)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Administrative Order "Rules and Regulations on the Issuance of Authorization for 
Registration Applications of Drug Products and Drug Substances by the Food and Drug 
Administration"; (22 page(s), in English)  
6. Description of content:  A. This Administrative Order is issued to provide the guidelines 
including the rules and regulations on registration applications for the issuance of FDA 
authorizations and other certifications for drug products and drug substanc es. 
B. Specifically, this AO shall provide the regulatory guidelines for the following:  
1. Identification of registrable drug products and drug substances;  
2. Types of registration applications for drug authorization;  
3. Regulatory review implemented by th e FDA on the applications and the applicable 
evaluation routes; and  
4. Regulatory decisions on the applications.  G/TBT/N/PHL/305  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  improve efficiency and adopt digitalization in government regulatory services  
8. Relevant documents:   
● Administrative Order No. 67 s. 1989: Revised Rules and Regulations on Registration of 
Pharmaceutical Products;  
● Administrative Order No. 96 s. 1990: Guidelines on the Registration  of Fixed -Dose 
Combination Drug Products;  
● Administrative Order No. 117 s. 1992: Providing for the Classification of Household 
Remedies;  
● Administrative Order No. 23 -c s. 2000: Policies and Guidelines on Over -the-Counter 
(OTC) Drug Products;  
● Administra tive Order No. 142 s. 2004: Bureau of Food and Drugs (BFAD)'s issuance of 
Certificate of Product Registration for Foreign Assisted Projects Procurement and 
Laboratory Testing of Pharmaceutical and Biological products Procured by and/or 
delivered to the Dep artment of Health;  
● Administrative Order No. 172 s. 2004: Guidelines on the Registration of Herbal 
Medicines;  
● Administrative Order No. 184 s. 2004: Guidelines on the Registration of Traditionally -
Used Herbal Products;  
● Administrative Order No. 2005 -0007: Amending Administrative Order No. 142, s. 2004 
by providing exemption from the requirement of Certificate of Product Registration for all 
goods procured through UNICEF, UNDP, WHO, and GDF;  
● Administrative Order No. 2005 -0030: Guidelines and Procedure f or the Automatic 
Renewal of the Certificate of Product Registration issued by the Bureau of Food and Drugs;  
● Administrative Order No. 2005 -0031: Guidelines and Procedure for the Issuance of the 
Principal Certificate of Product Registration and the Listing of Identical Drug Products 
based on the Identity of Manufacturer and Pharmaceutical Formulation;  
● Administrative Order No. 2006 -0021: Supplemental Guidelines to Administrative Order 
(AO) 67 s. 1987, Revised Rules and Regulations on Registration of  Pharmaceutical 
Products and Bureau Circular 05 s. 1997 in evaluating New Drug Applications;  
● Administrative Order No. 2016 -0008: Revised Rules and Regulations Governing the 
Generic Labeling Requirements of Drug Products for Human Use;  
● Administrative Or der No. 2020 -0001: Guidelines in the Importation, Facilitation, and 
Management of Foreign Donations involving Health and Health -Related Products;  
● Bureau Circular No. 12 s. 1991: Clarification of New Registration when there is a Change 
of Manufacturer;  
● Bureau Circular No. 5 s. 1997: Revised Checklist of Requirements and the 1997 
Guidelines for the Registration of Pharmaceutical Products; and  
● FDA Circular No. 2021 -020: Revised Post -Marketing Surveillance Requirements for New 
Drugs under Monitored Releas e. 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  This Order shall take effect fifteen (15) days after 
the publication in the Official Gazette or a newspaper of general circulation and filing with 
the University of the P hilippines Office of the National Administrative Register.  
10. Final date for comments:  31 July 2023  G/TBT/N/PHL/305  
 
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  11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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  
Tel: (632) 751 4700; (632) 7913128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/draft -for-comments -rules-and-regulations -on-the-issuance -of-
authorization -for-registration -applications -of-drug-products -and-drug-substances -by-
the-food-and-drug-administration/  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10948_00_e.pdf  
https:/ /members.wto.org/crnattachments/2023/TBT/PHL/23_10948_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10948_02_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10948_03_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10948_04_e.pdf