G/TBT/N/PHL/289  
1 June 2022  
(22-4141) 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:   
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  
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):  
Investigational products used in clinical trials for public health emergency, rare disease, 
cancer HIV/AIDS and emerging and re -emerging infectious disease of public health 
threats  
5. Title, number of pages and language(s) of the notified document:  Guidelines on 
Regulatory Reliance on the Conduct of Clinical Trials in the Philippines; (6 page(s), in 
English)  
6. Description of content:  The proposed issuance aims to provide guidelines on r eliance 
for approval of clinical trials and to promote a more efficient and effective approach to 
the regulations in the oversight of the conduct of clinical trials in the Philippines.  
7. Objective and rationale, including the nature of urgent problems w here 
applicable:  The FDA recognizes that reliance will further streamline the review process 
and accelerate the conduct of clinical trials in the country. Streamlined processes will 
boost local competitiveness and attract more local and foreign sponsors. T his will facilitate 
the evaluation and improve access of investigational drug products for public health 
emergency, rare disease, cancer HIV/AIDS and emerging and re -emerging infectious 
disease of public health threats  G/TBT/N/PHL/289  
 
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  8. Relevant documents:   
• Republic Act No. 9711 "Food and Drug Administration (FDA) Act of 2009"  
• Administrative Order No. 2020 -0010 "Regulations on the Conduct of Clinical Trials 
for Investigational Products"  
• World Health Organization (WHO) Technical Report Series, No. 1033, 2021 
(annex 10, Good reliance practices in the regulation of medical products: high 
level principles and considerations)  
• International Council for Harmonization (ICH) Guidelines E6 (R2): Good Clinical 
Practice  
• International Council for Harmonization (ICH) Guidel ines E17: General Principles 
for Planning and Design of Multi -Regional Clinical Trials  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) calendar days 
after publication in one (1) newspaper of general circulation and upon filing with the 
University of the Philippines, Office of the National Administrative Register (ONAR)  
Proposed date of entry into force:  Upon effectivity  
10. Final date for comments:  3 June 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  
Makat i City 
Philippines  
Tel: (632) 751 4700; (632) 7913128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_3815_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_3815_01_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_3815_02_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_3815_03_e.pdf