Revised FDA Citizen's Charter ( FDA Memorandum Circular No. 004-15 )

February 17, 2015

February 17, 2015


TO : All FDA Centers/Offices and FDA Regulated Establishments
SUBJECT : Revised FDA Citizen's Charter


Please be informed that the Civil Service Commission (CSC) has approved the Food and Drug Administration's (FDA's) proposal to revise the FDA Citizen's Charter as part of its on-going commitment to improve compliance with Republic Act 9485 (Anti Red Tape Act of 2007).

The revised durations of process are as follows:


Responsible Office
Duration of
1 Filing and receiving of applications Public Assistance, 5 calendar days
        Information and
        Receiving (PAIR)
2 Inspection/Issuance of Certificate of Regional Field Offices 61 calendar days
3 Issuance of License to Operate CCRR, CDRR, CFRR 30 calendar days
4 Issuance of Certificate of Product of CDRR  
  Registration (CPR)    
  Initial   254 calendar days
  Renewal   68 calendar days
  Automatic Renewal   33 calendar days
  CLIDP   31 calendar days
  Variations   52 calendar days
5 Issuance of Certificate of Product of CFRR  
  Registration (CPR)    
  Initial/Renewal   114 calendar days
  Automatic Renewal/   57 calendar days
    Permit to Market (PPM)    
6 Issuance of Certificate of Product of CCRR  
  Registration (CPR)/Notification    
  Cosmetic Notification   14 calendar days
  HUHS Notification   14 calendar days
  HUP CPR - Initial 175 calendar days
      - Renewal 28 calendar days
  Toys and Childcare Articles   30 calendar days
  TCCA Certificate of    
    Conformity - Compliant   42 calendar days
      - with deficiencies 64 calendar days
7 Batch Notification Central 2 calendar days
  Lot Release Certificate Laboratory 9 calendar days
  Laboratory Test Report   7 to 80 calendar
8 Issuance of Other Certifications/    
  Certificate of Pharmaceutical    
    Products (CoPP) CDRR 14 calendar days
  Certificate of Free Sale (CFS) CDRR/CCRR 14 calendar days
  Export Certificate (EC) CDRR/CCRR 14 calendar days
  Food Export and Commodity Central 2 calendar days
    Clearance Laboratory  
  Sales Promotion and CCRR, CDRR, 14 calendar days
    Advertisement Permit CFRR  

The FDA will periodically review its systems and processes to continually improve the committed turn around time. ETIcHa

This order shall take effect on 02 March 2015.

For your guidance and strict compliance.


(SGD.) ATTY. NICOLAS B. LUTERO III, CESO IIIOIC, Director IV Food and Drug Administration