G/TBT/N/PHL/262  
19 August 2021  
(21-6292) 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 diffe rent from above:   
Ms. Jesusa Joyce N. Cirunay  
Center for Drug Regulation and Research  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: cdrr.od@fda.gov.ph   
www.fda.go v.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):  Drug 
Products, including vaccines and biologicals; Pharmaceutics (ICS 11.120), Tobacco, 
tobacco products and related equipment (ICS 65.160)  
5. Title, number of pages and language(s) of the notified document:  Revised 
Postmarketing Surveillance Requirement s for New Drugs under Monitored Release (4 
page(s), in English)  
6. Description of content:  The proposed issuance intends to provide updated post -
marketing surveillance (PMS) requirements for new drugs under monitored release.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• Republic Act No. 9711, "Food and Drug Administration Act of 2009"  
• Department of Health (DOH) Administrative Order No. 2006-0021, "Supplemental 
Guidelines to Administrative Order (AO) 67 s. 1987, Revised Rules and Regulations on 
Registration of Pharmaceutical Products and Bureau Circular 5 s. 1997 in Evaluating New 
Drug Applications"  
• DOH Administrative Order No. 2011 -0009, "National Policy and Program on 
Pharmacovigilance"  G/TBT/N/PHL/262  
 
- 2 - 
 
  • FDA Circular No. 2018 -012, "Rescinding FDA circular No. 2013 -004 and Instituting Post -
Marketing Surveillance (PMS) Requirements for New Drugs under Monitored Release"  
• FDA Circular No. 2020 -003, "Gui delines for Pharmaceutical Industry on 
Pharmacovigilance"  
9. Proposed date of adoption:  Fifteen (15) days after publication in a newspaper of 
general circulation and/or the Official Gazette and filing of the required copies with the 
University of the Philippines - Office of the National Administrative Register  
Proposed date of entry into force:  Upon effectivity.  
10. Final date for comments:  31 August 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:   
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 1200  
(632) 7751 4700; (632) 7751 4706  
Email: bps@dti.gov.ph  
http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/draft -for-comments -of-revised -post-marketing -surveillance -
requirements -for-new-drugs -under -monitored -release -2/