G/TBT/N/PHL/270  
7 October 2021  
(21-7555) 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:   
Department of Health  
Food and Drug Administration Philippines  
Field Regulatory Operations Office  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regardin g the notification shall be indicated if different from above:   
DR. ROLANDO ENRIQUE D. DOMINGO  
Director -General  
 
DR. OSCAR G. GUTTIERREZ, JR. MPA.  
Deputy Director General - Field Regulatory Operations Office (DDG -FROO)  
Field Regulatory Operations Office  
Email: oddgfroo@fda.gov.ph  
Phone: (02) 8857 1900 local 8309  
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):  
Pharmaceutical products; Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Administrative 
Order No. _____: Revised Guidelines  on Good Manufacturing Practice (GMP) Clearance 
for Foreign Drug Manufacturers (12 page(s), in English)  
6. Description of content:  To update the current guidelines on the Foreign GMP Clearance 
requirements and the processes on application for initial, var iation and renewal for foreign 
drug manufacturers represented by the drug distributor -importers intending to register 
and supply finished drug products and active pharmaceutical ingredients in the country.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Reducing trade barriers and facilitating 
trade  
8. Relevant documents:   
• Administrative Order (AO) No. 2013 -0022 "Guidelines for Current Good 
Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug 
Manufacturers"  G/TBT/N/PHL/270  
 
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  • FDA Circular No. 2014 -016 Implementing Guidelines  
• FDA Circular No. 2020 -020 "Interim Guidelines Governing the Issuance of a 
Permit to Register to Drug Importers for Foreign Drug Manufacturers"  
• FDA Cir cular No. 2020 -024 "Updated Guidelines for Application of Authorizations 
at the Food and Drug Administration in Light of the Community Quarantine 
Declarations"  
9. Proposed date of adoption:  15 January 2022  
Proposed date of entry into force:  1 February 2022  
10. Final date for comments:  29 November 2021  
11. Texts available from:  National enquiry point [ ] 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) 7514700; (632) 7913128  
bps@dti.gov.ph  
http://www.bps.dti.gov.ph  
Head of Organization