G/TBT/N/PHL/290  
15 June 2022  
(22-4651) 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 ; cdrr.sds@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):  WHO-
prequalified pharmaceutical products and vaccines  
5. Title, number of pages and language(s) of the notified document:  Implementing 
Guidel ines on the Collaborative Procedure for the Accelerated Registration of World Health 
Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines; (6 page(s), in 
English)  
6. Description of content:  The proposed issuance aims to provide the imple menting 
guidelines of the collaborative procedure for accelerated registration of WHO -prequalified 
pharmaceutical products and vaccines to guide the concerned stakeholders.  
7. Objective and rationale, including the nature of urgent problems where 
applicab le: The FDA, together with the DOH, are tasked to ensure that there is a constant 
supply of drugs, including vaccines, and that there is facilitated access to safe, effective, 
and quality drugs. Given the current resource constraints affecting drug regulat ion, 
collaboration and regulatory convergence with international organizations such as the 
WHO are necessary. This Circular aims to provide the implementing guidelines of AO No. 
2020-0044 which adopted the collaborative procedure for accelerated registrati on of 
WHO-prequalified pharmaceutical products and vaccines.; Protection of human health or 
safety  G/TBT/N/PHL/290  
 
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  8. Relevant documents:   
• Republic Act No. 9711 "Food and Drug Administration (FDA) Act of 2009"  
• Administrative Order No. 2020 -0044 "Adoption of the Collaborative Procedure for 
the Accelerated Registration of World Health Organization (WHO) – Prequalified 
Pharmaceutical Products and Vaccines"  
• World Health Organization (WHO) Technical Report Series, No. 996, 2016 (Annex 
8, Collaborative procedure betwee n the World Health Organization (WHO) 
Prequalification Team and national regulatory authorities in the assessment and 
accelerated national registration of WHO -prequalified pharmaceutical products 
and vaccines)  
9. Proposed date of adoption:  This Circular s hall 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:  17 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  
Makati City  
Philippines  
Tel: (632) 7791.3127 ; (632) 7791.3128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/draft -for-comments -implementing -guidelines -on-the-
collaborative -procedure -for-the-accelerated -registration -of-world -health -organization -
who-prequalified -pharmaceutical -produ cts-and-vacc/  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_01_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_02_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_03_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_04_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_05_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_4120_06_e.pdf  
https:/ /members.wto.org/crnattachments/2022/TBT/PHL/22_4120_07_e.pdf