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Singapore Drug Registration Information and Guidelines

Guidance on Medicinal Product Registration in Singapore

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)
2B.   
Application Checklist for MAV (ICH CTD)
3A.   
Application Checklist for NDA & GDA (ACTD)
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)
2B.     Application Checklist for MAV (ICH CTD)
3A.     Application Checklist for NDA & GDA (ACTD)
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


Other Application / Submission Guidelines


ASEAN Registration of Pharmaceuticals for Human Use

ASEAN Common Technical Dossier (ACTD)


ASEAN Common Technical Requirements (ACTR)


Last updated on 04 Jan 2012 13:28:30
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