G/TBT/N/PHL/308  
4 August 2023  
(23-5324) 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 noti fication 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  ; BPS@dti.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):  
Pharmaceutics (ICS code(s): 11.120)  
5. Title, number of pages and language(s) of the notified document:  Applicati on 
Process and Requirements for Post -Approval Changes of Biological Products Adopting the 
World Health Organization Guidelines for Changes to Approved Vaccines and 
Biotherapeutic Products for Human Use; (91 page(s), in English)  
6. Description of content:  The objectives of this Circular are:  
1. To promulgate the revised requirements in instituting post -approval changes to 
registered biological products, incorporating the WHO and country -specific requirements; 
and 
2. To provide the application process for po st-approval changes.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  By virtue of Administrative Order (A.O.) No. 47 -a, series of 2001 entitled 
"Rules and Regulations on the Registration, Including Approval and Conduct of Clinical 
Trials, and Lot or Batch Release Certification of Vaccines and Biological Products", the 
Annex  4 of World Health Organization (WHO) Technical Report Series (TRS) No. 993 and G/TBT/N/PHL/308  
 
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  Annex 3 of 1011 serve as the standard for the evaluation of applications for the 
registration of vaccines and biotherapeutic products.  
With the intent to harmonize regulatory requirements for pharmaceutical products, 
including vaccines and biotherapeutic products, among ASEAN member states, AO No. 
2013-0021 entitled "Adoption of the Association of Southeast Asian Nations (ASEAN) 
Common Technical Dossier (ACTD) and Co mmon Technical Requirements (ACTR) for 
Registration of Pharmaceutical Products for Human Use" was issued. Relative thereto, the 
Food and Drug Administration (FDA) issued FDA Circular (FC) No. 2014 -008 entitled 
"Application Process and Requirements for Post -Approval Changes of Pharmaceutical 
Products" which became effective on 01 April 2014 to promulgate the revised application 
process and requirements for instituting Post -Approval Changes (PAC) to registered 
pharmaceutical products, which covered both the A SEAN Variation Guidelines (AVG) for 
Pharmaceutical Products and country -specific regulatory requirements.  
The application process and requirements for PAC of pharmaceutical products have then 
evolved with the implementation of FC No. 2014 -008-A, "Amendment  to Annex B, 
Notification for Minor Variation of FDA Circular No. 2014 -008 entitled "Application Process 
and Requirements for Post -Approval Changes of Pharmaceutical Products", specifically on 
Section IV, C, D, and E for Minor Variation -Notification "effec tive 01 July 2016, and FC 
No. 2016 -017, "Additional Post -Approval Changes for Pharmaceutical Products" effective 
03 October 2016.  
The above regulations are intended to provide supportive information on the process and 
requirements for changes to small mole cule/chemically -synthesized drug products. 
However, given the complexity and current challenges of global life -cycle management of 
vaccines and biotherapeutic products, the need to develop a specific and pertinent 
guideline for changes to approved biologic al products is imperative.  
8. Relevant documents:   
• Administrative Order (A.O.) No. 47 -a, series of 2001 entitled "Rules and 
Regulations on the Registration, Including Approval and Conduct of Clinical Trials, 
and Lot or Batch Release Certification of Vacci nes and Biological Products"  
• Annex 4 of World Health Organization (WHO) Technical Report Series (TRS) No. 
993 and Annex 3 of 1011  
• AO No. 2013 -0021 entitled "Adoption of the Association of Southeast Asian 
Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical 
Requirements (ACTR) for Registration of Pharmaceutical Products for Human Use"  
• FDA Circular (FC) No. 2014 -008 entitled "Application Process and Requirements 
for Post -Approval Changes of Pharmaceutical Products"  
• FC No. 2014-008-A, "Amendment to Annex B, Notification for Minor Variation of 
FDA Circular No. 2014 -008 entitled "Application Process and Requirements for 
Post-Approval Changes of Pharmaceutical Products"  
9. Proposed date of adoption:  To be determined  
Proposed d ate of entry into force:  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).  
10. Final date for comments:  15 August 2023  G/TBT/N/PHL/308  
 
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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 -application -process -and-requirements -for-
post-approval -changes -of-biological -products -adopti ng-the-world -health -organization -
guidelines -for-changes -to-approved -vaccines -and-bioth/  
https://members.wto.org/crnattachmen ts/2023/TBT/PHL/23_11504_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_11504_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_11504_02_e.pdf