G/TBT/N/PHL/267  
28 September 2021  
(21-7249) 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:   
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  
Email: cdrr.od@fda.gov.ph  
Website: www.fda.gov.ph   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Human 
blood; animal blood prepared for therapeutic, pr ophylactic or diagnostic uses; antisera 
and other blood fractions and immunological products, whether or not modified or 
obtained by means of biotechnological processes; vaccines, toxins, cultures of micro -
organisms (excl. yeasts) and similar products (HS 3002); Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Implementation 
of Abridged and Verification Review Pathways for New Drug, Initial Registration and Post -
Approval Changes Applications of Drug Products, i ncluding Vaccines and Biologicals (6 
page(s), in English)  
6. Description of content:  The proposed issuance aims to provide the implementing 
guidelines on facilitated registration pathways (FRPs) through abridged review or 
verification review of drug produ cts, including vaccines and biologicals as per 
Administrative Order No. 2020 -0045.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Streamlining its regulatory review to accelerate the registration process for 
medicine s, by leveraging against product regulatory assessments made by reference drug 
regulatory authorities (RDRAs), especially during the pandemic.; Protection of human 
health or safety; Reducing trade barriers and facilitating trade  G/TBT/N/PHL/267  
 
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  8. Relevant documents:   
• Republic Act No. 9711, "Food and Drug Administration Act of 2009"  
• Republic Act No. 11032, "Ease of Doing Business and Efficient Government 
Service Delivery Act of 2018"  
• Administrative Order (AO) No. 2020 -0045, "Establishing Facilitated Registra tion 
Pathways for Drug Products, including Vaccines and Biologicals"  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) days following 
its publication in a newspaper of general circulation and upon filing to 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:  5 October 2021  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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  
1200  
(632) 7751 4700; (632) 7751 4706  
bps@dti.gov.ph  
 http://www.bps.dti.gov.ph  
Head of Organization  
 
https://www.fda.gov.ph/draft -for-comments -implementation -of-abridged -and-
verification -review -pathways -for-new-drug-initial -registration -and-post-approval -
changes -applications -of-drug-products -including -vaccines -and-bio/