Guidance on Medicinal Product Registration in Singapore

Singapore Drug Registration Information and Guidelines

Guidance on Medicinal Product Registration in Singapore

Announcement - Revision to Guidance on Medicinal Product Registration in Singapore (Mar 2012)

Guidance on Medicinal Product Registration in Singapore (Effective 1 April 2011)

• Complete Guidance Document (includes all appendices) 
• Main Guidance Document only (without appendices)

Appendices

1.      Target Processing Timelines
2A.    Application Checklist for NDA & GDA (ICH CTD) (Feb 2012)
2B.    Application Checklist for MAV (ICH CTD)
3A.    Application Checklist for NDA & GDA (ACTD) (Feb 2012)
3B.    Application Checklist for MAV (ACTD)
4.      Flowchart on Translation of Non-English Documents
5.      Guideline on Submission for Non-Prescription Medicinal Products
6.      Points to Consider for Singapore Labelling
7.      Patent Declaration Form
8.      Singapore Quality Overall Summary for Chemical Drugs
9.      Singapore Quality Overall Summary for Biologics
10.    Guideline on the Registration of Human Plasma-derived Medicinal Products
11.    Guideline on the Registration of Human Medicinal Products Containing Materials of Animal Origin
12.    Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications
12A. Quick Reference for Acceptability of Bioequivalence Study
13.    Guideline on Submission under CECA Scheme
14.    MIV Filing and Submission Inquiry Form
15.    Guideline on MIV Applications for Chemical Drugs
16.    Guideline on MIV Applications for Biologics
17.    Guidance on Registration of Similar Biological Products in Singapore

Template Downloads (MS Word format)

Appendices

 

2A.     Application Checklist for NDA & GDA (ICH CTD) (Feb 2012)2B.     Application Checklist for MAV (ICH CTD)
3A.     Application Checklist for NDA & GDA (ACTD) (Feb 2012)3B.     Application Checklist for MAV (ACTD)
7.       Patent Declaration Form
8.       Singapore Quality Overall Summary for Chemical Drugs
9.       Singapore Quality Overall Summary for Biologics
10.     Checklist for Registration of Human Plasma-derived Medicinal Products
11.     Checklist for Registration of Human Medicinal Products Containing Materials of Animal Origin
12A.  Quick Reference for Acceptability of Bioequivalence Study
14.     MIV Filing and Submission Inquiry Form
15.     Part B Checklist for MIV-1 Applicaitons for Chemical Drugs 
           Part C Checklist for MIV-2 Applications for Chemical Drugs
16.     Part B Checklist for MIV-1 Applications for Biologics
           Part C Checklist for MIV-2 Applications for Biologics
           Part D Checklist for Plasma MAster File Variations for Biologics

Guidance on Registration of Similar Biological Products in Singapore

• Guidance on Registration of Similar Biological Products in Singapore

Other Application / Submission Guidelines

• Guideline for Renewal of Product Licence
• Guideline for Application to Transfer Product Licence
• Guideline on Submission of Notification to Import Medicinal Products for Re-Export
• Guideline on Submission of Application for a Licence to Import a Medicinal Product on Consignment Basis
• Guideline to Apply for Approval to Import an Unregistered Medicinal Product for Use on Named-Patient Basis

ASEAN Registration of Pharmaceuticals for Human Use

ASEAN Common Technical Dossier (ACTD)

• Organisation of the Dossier
• Glossary used for the ACTD and ACTR
• Part II: Quality
• Part III: Nonclinical Document
• Part IV: Clinical Document
• ACTD Clinical Check List for Product Classification

ASEAN Common Technical Requirements (ACTR)

• ASEAN Variation Guidelines (draft) [NEW]
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (includes all annexes)
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (Main Guide; without all annexes)
  • 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 Sterilised Products
  • Annex B Table of Content of Process Validation Documentation
  • Annex C Guidance for Quality By Design as an Alternative Approach to Process Validation (DRAFT)
  • Annex D Glossary
• ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies
• ASEAN Guideline on Stability Study of Drug Product 
• ASEAN Guideline for Validation of Analytical Procedures
• ASEAN Guideline on Process Validation Q&A
• ASEAN Guideline on Analytical Validation Q&A

Industry consultations

Please click here for a list of public consultations