Citizen Charter – Center for Drug Regulation and Research (CDRR)

Center for Drug Regulation and Research (CDRR)

CLEARANCE AND CERTIFICATES

OTHER

A. Accreditation Certificate to Bioequivalence (BE) Testing Centers (Initial and Renewal)

B. Foreign Good Manufacturing Practice (GMP) Clearance (Desktop Evaluation) [For Non-Pic/S-Member Countries]

C. Foreign Good Manufacturing Practice (GMP) Clearance (Desktop Evaluation) [For Pic/S-Member Countries]

D. Certificate of Product Registration

  1. Certificate of Product Registration (CPR) of Pharmaceutical Products (New Chemical Entities/Monitored Release)
  2. Certificate of Product Registration (CPR) Of Biologicals and Vaccines (New Chemical Entities/Monitored Release and Initial)
  3. Post Marketing Surveillance (Phase Iv Clinical Trial) Protocol [As Post-Approval Requirement If Additional Activity (ies) are Necessary Based on FDA Circular No. 2021-020]
  4. Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial – Reproductive Health Products)
  5. Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial   – Prescription Generic Drugs)
  6. Abridged Review Pathway of Certificate of Product Registration (CPR) of New Drug Products for Human and Veterinary Use Including Vaccines and Biologicals
  7. Verification Review Pathway of Certificate of Product Registration (CPR) of New Drug Products for Human and Veterinary Use Including Vaccines and Biologicals
  8. Certificate for Pharmaceutical Products (Major and Minor Variation-Prior Approval) via Facilitated Registration Pathway (FRP)
  9. Certificate of Product Registration (CPR) of Pharmaceutical Products for Human and Use including Vaccines and Biologicals through the WHO Collaborative Registration Procedure (CRP)
  10. Certificate for Post-Approval Changes of Pharmaceutical Products for Human Use Including Vaccines and Biologicals Through the Who Collaborative Registration Procedure (CRP)
  11. Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial – Veterinary Drugs and Products)
  12. Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial – Over-the-Counter Drugs and Household Remedy)
  13. Certificate of Product Registration (CPR) Of Pharmaceutical Products (Initial – Medical Grade Oxygen)
  14. Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial – Herbal Medicine/Traditionally-Used Herbal Products)
  15. Certificate of Product Registration (CPR) of Reproductive Health (RH) Products (Automatic Renewal) [Manual Submission]
  16. Certificate of Product Registration (CPR) of Pharmaceutical Products (Electronic Automatic Renewal) [E-AR]
  17. Certificate of Product Registration for Pharmaceutical Products (Variation-Turned-Initial Applications)
  18. Certificate for Pharmaceutical Products (Major Variation Except for Variations Classified as Turned Initial Applications as per FDA Circular No. 2014-008)
  19. Certificate for Pharmaceutical Products (Minor Variation – Prior Approval Except for Variations Classified as Turned Initial Applications as per FDA Circular No. 2014-008)
  20. Certificate of Product Registration (CPR) of Pharmaceutical Products (Principal Certificate of Product Registration Conversion)
  21. Electronic Principal Certificate of Product Registration (E-PCPR) Conversion of Pharmaceutical Products
  22. Certificate for Major Variation – Strain Clearance (Mav-Sc) and Minor Variation – Strain Clearance (MIV-SC) of Human Influenza Vaccines
  23. Acknowledgement to Minor Variation-Notification Applications
  24. Certificate of Product Registration (CPR) Of Pharmaceutical Products (Regular Renewal)


E. Clearance and Certificate for Foreign Donations

F. Certificate of Listing of Identical Drug Products (CLIDP) of Pharmaceutical Products (Electronic Certificate of Listing of Identical Drug Products) [E-CLIDP]

G. Certificate of Pharmaceutical Products (COPP), Certificate of Free Sale (CFS), Export Certificate (EC), and Generic Labeling Exemption (GLE)

H. Bureau Of Customs (BOC) Clearance [Import Permit and Export Permit)

I. Compassionate Special Permit (CSP) of Pharmaceutical Products [Manual Submission]

J. Issuance of Electronic Compassionate Special Permit (ECSP) of Pharmaceutical Products

K. Clinical Trial Approval (CTA) and Import License Approval (ILA) [Initial]

L. Clinical Trial Amendment Approval

M. Initial Clinical Trial and Import License Application Under Regulatory Reliance

N. Clinical Trial Amendment Under Regulatory Reliance

O. Sales Promo Permit of Pharmaceutical Products (Initial and Amendment)

P. Product Classification

Q. Import License Amendment

R. Import License Notification

Field Regulatory Operations Office Inspection Agenda

  • Bureau of Customs – For Donation
  • Bureau of Customs – For Personal Use

Food and Drug Action Center (FDAC)

  1. Issuance of Electronic Portal (E-Portal) User Account
  2. Issuance of Appointment Schedule and Document Tracking Number
  3. Filling of Complaint (Walk-in)
  4. Filling of Complaint (Online)
  5. Receiving of Application(s) and Other Documents of FDAC – Public Assistance and Complaint Desk (PACD) and Letter Section
  6. Assistance to Phone Callers

 

Feedback and Complaint Mechanism