G/TBT/N/PHL/253  
4 June 2021  
(21-4588) 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  
Center For Food Regulation and Research  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding th e notification shall be indicated if different from above:   
DR. ROLANDO ENRIQUE D. DOMINGO  
Director -General  
JESUSA JOYCE N. CIRUNAY, RpH  
Director ,  
Center for Food Regulation and Research  
Email: jjncirunay@fd a.gov.ph  ; cdrr.od@fda.gov.ph ; rmvmorante@fda.gov.ph ; 
pps@fda.gov.ph   
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):  
Pharmaceutical products; Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  FDA Circular 
No._____: Interim Guidelines on the Renewal of Current Good Manufacturing Practice 
(cGMP) Cle arance of Foreign Drug Manufacturers (3 page(s), in English)  
6. Description of content:  Considering the COVID -19 pandemic and consistent with the 
spirit and continuing policy of the government manifested in the pertinent objectives and 
the declared COVID -19 response and recovery interventions provided under Republic Act 
No. 11494 or the "Bayanihan to Recover As One Act", this Circular is being issued to 
provide the interim guidelines on the renewal of cGMP clearance of foreign drug 
manufacturers.  
7. Objec tive and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Reducing trade barriers and facilitating 
trade  G/TBT/N/PHL/253  
 
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  8. Relevant documents:   
• Administrative Order (AO) No. 2013 -0022 "Guidelines for Current Good 
Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug 
Manufacturers"  
• 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 Circular 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:  10 June 2021  
Proposed date of entry into force:  10 June 2021  
10. Final date for comments:  N/A 
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) 751 4700; (632) 7913128  
bps@dti.gov.ph  
http://www.bps.dti.gov.ph  
Head of Organization  
 
https://www.fda.gov.ph/wp -content/uploads/2021/05/Draft -FDA-Circular -on-Interim -
Guidelines -for-cGMP -Clearance_f or-posting.docx.pdf  
 
https://members.wto.org/crnattachments/2021/TBT/PHL/21_3797_00_e.pdf