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

• Guidance on Registration of Similar Biological Products in Singapore

• Guideline for Renewal of Product Licence
• Guideline for Application to Transfer Product Licence
• Guideline on Submission of Notification to Import Medicinal Products for Re-exportation
• 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 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 Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
  • Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
  • Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilised Products

• ASEAN Guidelines for Validation of Analytical Procedures
• ASEAN Guideline on Stability Study of Drug Product
• ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies
• ASEAN Guideline on Process Validation Q&A