G/TBT/N/PHL/296  
12 December 2022  
(22-9254) 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 notific ation shall be indicated if different from above:   
Irene V. Florentino -Fariñas, RPh., MD, MNSA  
OIC-Director, Policy and Planning Service  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: pps@fda.gov.ph  ; iffarinas@fda.gov.ph  
www.fda.gov.ph   
3. Notified under Article 2.9.2 [  ], 2.10.1 [X], 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):  Medical 
equipment (ICS code(s): 11.040); Sterilization and disinfection (ICS code(s): 11.080); 
Laboratory medicine (ICS code(s): 11.100); Pharmaceutics (ICS code(s): 11.120); 
Hospital equipment (ICS code(s): 11.140); Birth control. Mechanical contraceptives (ICS 
code(s): 11.200); Veterinary medicine (ICS code(s): 11.220); Processes in the f ood 
industry (ICS code(s): 67.020); Food products in general (ICS code(s): 67.040); General 
methods of tests and analysis for food products (ICS code(s): 67.050); Cereals, pulses 
and derived products (ICS code(s): 67.060); Milk and milk products (ICS code( s): 
67.100); Meat, meat products and other animal produce (ICS code(s): 67.120); Tea. 
Coffee. Cocoa (ICS code(s): 67.140); Beverages (ICS code(s): 67.160); Sugar. Sugar 
products. Starch (ICS code(s): 67.180); Chocolate (ICS code(s): 67.190); Edible oils an d 
fats. Oilseeds (ICS code(s): 67.200); Spices and condiments. Food additives (ICS 
code(s): 67.220); Prepackaged and prepared foods (ICS code(s): 67.230); Materials and 
articles in contact with foodstuffs (ICS code(s): 67.250); CHEMICAL TECHNOLOGY (ICS 
code(s): 71); PAINT AND COLOUR INDUSTRIES (ICS code(s): 87)  
Other products may fall under the said regulation.  
5. Title, number of pages and language(s) of the notified document:  Guidelines 
Prescribing the Principle of Reliance for Regulatory Decisions of th e Food and Drug 
Administration; (6 page(s), in English)  G/TBT/N/PHL/296  
 
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  6. Description of content:  The FDA, in cognizance of reliance application, shall leverage 
its review process to accelerate its regulatory decisions of FDA to provide coherence in 
the FDA's regulatory  system for establishments and products under its jurisdiction 
Effective implementation of reliance will benefit not only the Agency but also the 
patients/clients, healthcare providers, Marketing Authorization Holders (MAH) and other 
stakeholders. This wil l consequently strengthen post -marketing surveillance and promote 
continuous improvement in building FDA's institutional capacity towards effectively 
safeguarding public health.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Order aims to institutionalize reliance in the regulatory processes 
covering health products and establishments as determined by the FDA. Specifically, it 
shall aim to:  
A. Expedite the submission and/or evaluation of authorization application s towards their 
timely approval,  
B. Make greater efficiency to the regulatory process by eliminating duplicative work, 
strengthen regulatory systems, and optimize resource utilization with a focus on value -
added activities without sacrificing product quali ty, safety, or efficacy; and,  
C. Optimize innovative and more effective forms of international collaboration or 
measures by use of available resources/expertise to aid the FDA to address emerging 
concerns and to be abreast with internationally acceptable n orms and standards.; 
Protection of human health or safety; Reducing trade barriers and facilitating trade; Cost 
saving and productivity enhancement  
8. Relevant documents:   
• Republic Act (RA) No. 3720, "Food, Drugs and Devices, and Cosmetics Act" as 
amended by Executive Order (EO) No. 175 and RA 9711  
• Republic Act (RA) No. 9711, ""Food and Drug Administration (FDA) Act of 2009".  
• Republic Act (RA) No. 9502, "Universally Accessible Cheaper and Quality 
Medicines Act of 2008".  
• Republic Act (RA) No. 10611, "Food Safety Act of 2013".  
9. Proposed date of adoption:  This Order shall take effect immediately upon its 
publication in a newspaper of general circulation and/or filing of a copy of which to the 
University of the Philippines Office of the National Register.  
Proposed date of entry into force:  31 March 2023  
10. Final date for comments:  27 December 2022  G/TBT/N/PHL/296  
 
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  11. Texts available from:  National enquiry point [X] 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 -guidelines -prescribing -the-principle -of-
reliance -for-regulatory -decisions -of-the-food-and-drug-administration/  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_8522_00_e.pdf