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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE

Updates for Guidance on Medicinal Product Registration in Singapore [Updated 8 Jan 2014]

Related information:


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

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 (valid to 31 Mar 2014)
16.    Guideline on MIV Applications for Biologics (valid to 31 Mar 2014)
17.    Guidance on Registration of Similar Biological Products in Singapore 
18.    DMF Submission Form (effective 1 April 2014) [Updated 8 Jan 2014]

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 Applications for Chemical Drugs (valid to 31 Mar 2014)
          
Part C Checklist for MIV-2 Applications for Chemical Drugs (valid to 31 Mar 2014)
16.     Part B Checklist for MIV-1 Applications for Biologics  (valid to 31 Mar 2014)
          Part C Checklist for MIV-2 Applications for Biologics (valid to 31 Mar 2014) 
          Part D Checklist for Plasma Master File Variations for Biologics (valid to 31 Mar 2014)
 
Revised MIV-1/MIV-2 checklists (effective 1 April 2014)[Updated 8 Jan 2014]


 


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)


Industry consultations

27 Sept 2013: Industry Consultation on Drug Product Stability Data Requirements and ASEAN Variation Guideline Implementation (closing date 18 October 2013)

The consultation period for this paper is closed

The consultation period for this paper is closed

 

Please click here for a list of HPRG public consultations


Last updated on 23 Apr 2014 09:35:23
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