G/TBT/N/PHL/291  
6 July 2022  
(22-5196) Page: 1/2 
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. OSCAR G. GUTIERREZ, JR., MPA  
Officer -in-Charge 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 notification shall be indicated if different from above:   
Engr. Ana Trinidad F. Rivera, MSc  
Director IV  
Center for Cosmetics and Household/Urban Hazardous Substances Regulation and 
Research  
DEPARTMENT OF HEALTH  
Email: cchuhsrr@fda.gov.ph ; cchuhsrr -policy@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 or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Pesticides 
and other agrochemicals (ICS code(s): 65.100)  
5. Title, number of pages and language(s) of the notified document:  Guidelines on 
the Filing and Submission of Acceptable Variations on Protocols and Novel Protocols for 
the Review and Pre -Approval by the Food and Drug Administration Prior to the Conduct 
of Bio-efficacy Test Studies of Household Pesticides for the Purposes of Securing a 
Certificate of Product Registration; (10 page(s), in English)  
6. Description of content:  The proposed issuance aims to improve the regulatory 
compliance of pesticide registrat ion applications and facilitate the same through the 
establishment of a pathway for the review and pre -approval of novel and modified bio -
efficacy test protocols, which will be submitted in support of pesticide registration under 
DOH AO No. 2019 -0008.  G/TBT/N/PHL/291  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  An assessment of the implementation of Health (DOH) Administrative Order 
(AO) No. 2019 -0008 showed that pesticide registration applications were found to display 
deficiencie s in the submitted bio -efficacy test study which resulted in disapproved 
applications. Such applications displayed failure to substantiate claims and failure to 
justify modifications to accepted standards. In order to assist market authorization 
applicants , promote regulatory compliance, and ensure the efficient use of resources, this 
Circular hereby establishes the pre -approval process for modified and novel bio -efficacy 
test protocols.; Protection of human health or safety  
8. Relevant documents:   
• Republic Act No. 9711 "Food and Drug Administration (FDA) Act of 2009"  
• Department of Health (DOH) Administrative Order (AO) No. 2019 -0008, entitled "New 
Rules and Regulations in the Registration of Household Pesticide Products and their Active 
Ingredi ents" 
• DOH AO No. 50 s. 2001 "Revised 2001 Schedule of Fees and Charges"  
• Republic Act No. 11032 "The Ease of Doing Business and Efficient Government Service 
Delivery Act of 2018"  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) days after its 
publication in a newspaper of general circulation and filing with the University of the 
Philippines Law Center Office of the National Administrative Register.  
Proposed date of entry into force:  Upon effectivity  
10. Final date for comments:  29 July 2022  
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/wp -content/uploads/2022/06/Draft -for-comments -Pre-
approval -of-test-protocol.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4520_00_e.pdf