Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA)

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Checklist

• Drug Manufacturers
• Drug Distributors
• Drugstores
• RONPD's

Self Assessment Toolkits

• Drug Manufacturers
• Drug Distributors
• Drugstores
• RONPDs
• Sponsors and CROs SATKs

 Reference Materials for Drug Establishments

• PICS GMP
• Republic Acts and IRR
• Risk Management Plan and Pharmacovigilance
• WHO GDP and GSP
• PNDF 2008
• Notification Letter
• CAPA Plan
• Fees

Drug Registration

• New Drugs under Monitored Release
• Biological Products
• Generic Prescription Medicines
• Similar Biotherapeutic Products/Biosimilar
• Over the Counter Preparations and Household Remedies
• Herbal Medicines
• Traditional-Used Herbal Products
• Medical Gases (Oxygen)
• Veterinary Drugs
• Stem Cell Products
• Notification Form and Assessment Report for Tier 1 Application

Post-Approval Changes (PACs)

• Sample Letter of Request
• Annex C - Notification Form for Minor Variation/s of Registered Pharmaceutical Product as per FDA Circular No. 2020-026
• Notification for Minor Variation
• PACs under ASEAN Variation Guideline (refer below)
• PACs under Country-Specific Requirements

 

Guidance Documents

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ASEAN Common Technical Dossier (ACTD)

• ASEAN Common Technical Dossier (ACTD) December 2016 - from ASEAN Secretariat

Part I

• Glossary (used for the ACTD and ACTR) (November 2005)
• Organization of Dossier
• Organization of Dossier (Revision 1)
• Administrative Data (February 2005)

Part II

• Quality (April 2005)
• Quality (Revision 1)

Part III

• Non-Clinical (November 2005)
• Non-Clinical (Revision 1)

Part IV

• Clinical (November 2005)
• Clinical Checklist (November 2005)
• Clinical (Revision 1)

 ASEAN Common Technical Requirements(ACTR)

• ASEAN Common Technical Requirements (ACTR) December 2016 - from ASEAN Secretariat

Quality Data for Pharmaceutical Registration

Nonclinical Data (Safety) and Clinical Data (Efficacy) for Pharmaceutical Registration

 Analytical Validation

• ASEAN Guidelines for Validation of Analytical Procedures
• Analytical Validation Q&A Version (25 June 2012)
• ASEAN Guidelines for Validation of Analytical Procedures for Vaccines

Bioavailability & Bioequivalence Study

• ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies (July 2004)
• ASEAN Guideline for the Conduct of Bioequivalence Studies Revision 1, Draft 4 (March 2015) - Adopted at the 22nd PPWG Meeting
• Bioequivalence Study Reporting Format - Adopted at the 15th PPWG Meeting
• BA-BE Q&A Version 1 - Adopted at the 15th PPWG Meeting
• BA-BE Q&A Version 2 - Adopted at the 16th PPWG Meeting
• BA-BE Q&A Version 3 - Adopted at the 17th PPWG Meeting
• BA-BE Q&A Version 4 - Adopted at the 18th PPWG Meeting

Provisitional List

• FDA Philippines Provisional List of Comparator Products - as of 11 July 2019

Process Validation

• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration Version 3 (July 201) - Adopted at the 19th PPWG Meeting; with Annex A1, A2, A3, B, C (draft), and D
  • Annex A1: Guidance on Process Validation Scheme for Solid Oral Dosage Products
  • Annex A2: Guidance on Process Validation Scheme for Aseptically Processed Products
  • Annex A3: Guidance on Process Validation Scheme for Terminally Sterilized Products
  • Annex B: Table of Contents of Process Validation Documentation
  • Annex C: Guidance for Quality by Design as an Alternative Approach to Process Validation (draft)
  • Annex D: Glossary
• Process Validation on Q&A Version 4 (June 2011) - Adopted 18th PPWG Meeting

Stability

• ASEAN Guidelines on Stability of Drug Product (February 2005)
• ASEAN Guidelines on Stability of Drug Product Version 6.0 - Draft 5 (May 2013) - Adopted at the 20th PPWG Meeting and designated as (R1) at the 21st PPWG Meeting
• ASEAN Guideline on Stability Study of Drug Product (R2)
• Stability Q&A Version 1
• Stability (R1) Q&A No 1
• Stability Q&A Version 2
• Q&A on the Stability Evaluation of Vaccines

Variation

• ASEAN Variation Guideline for Pharmaceutical Products Final Draft 7.2 (2013) - Adopted at the 20th PPWG Meeting and designated as (R1) at the 21st PPWG Meeting
• ASEAN Variation Guideline for Pharmaceutical Products (R1)

Checklist of Requirements and Forms

• Clinical Trial Registration and Application Form
• Clinical Trial Protocol Amendment
• Permit to Import Clinical Trial Materials
• Assessment Slip

 

• Appendix C1_Table of Contents
• Appendix C2_Cover Letter
• Appendix C3_CT Application Form
• Appendix C4_IP Information
• Appendix C5_IL Application Form
• Appendix C6_Authorization
• Appendix D1_ Amendment Application Form
• Appendix D2_Cover Letter
• Appendix D3_IP Importation Report
• Appendix D4_Ancillary Importation Report
• Appendix G_Annual Report
• Appendix H_Notice of Inspection

Clinical Trial Registry

• Philippine Health Research Registry (PHRR)

• Checklist of Requirements for Compassionate Special Permit

• Annex B - Request for GMP Evidence Evaluation Form
• Annex D - Application Form for Foreign Manufacturing GMP Inspection
• Annex E - Affidavit of Undertaking
• List of Requirements for Foreign GMP Clearance
• Assessment Slip - Foreign GMP Clearance

• CIOMS Form I
• FDA ADR Form
• RMP Philippine-specific Annex Template

• Information Sheet and Mechanics of the Sales Promotion 
• CHECKLIST OF REQUIREMENTS FOR SPP
• Self Assessment Form for Sales Promo Permit

Recall Notification (TEMPLATE A)

Recall Notification (TEMPLATE B)

Recall Notification (TEMPLATE C)

Annex-Standards on Data Capture