Guidance on Medicinal Product Registration in Singapore
Drug Registration Guide - Complete Document (Effective from 1 January 2009)
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Drug Registration Guide - Individual Sections (Effective from 1 January 2009)
- DR Guide - Main guidance documents only (without appendices)
- Appendices
1. Target Processing Timelines
2. Application Checklist (ICH CTD)
3. Application Checklist (ACTD)
4. Guideline on Submission for Non-Prescription Medicinal Products
5. Flowchart for Translation of Non-English Documents
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
10A.Checklist for the Registration of Human Plasma-Derived Medicinal Products
11. Guideline on the Registration of Human Medicinal Products Containing Materials of Animal Origin
11A.Checklist for 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 on Acceptability of Bioequivalence Study
13. MIV Filing and Submission Inquiry Form
14. Guideline on Minor Variation Applications (MIV-1 & MIV-2) for Chemical Drugs
14A.Checklist for Minor Variation Application (MIV-1) for Chemical Drugs
14B.Checklist for Minor Variation Application (MIV-2) for Chemical Drugs
15. Guideline on Minor Variation Applications (MIV-1 & MIV-2) for Biologic
15A.Checklist for Minor Variation Application (MIV-1) for Biologics
15B.Checklist for Minor Variation Applications (MIV-2) for Biologics
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Guidance on Registration of Similar Biological Products in Singapore
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Other Application / Submission Guidelines
- Guideline for Renewal of Product Licence
- Guideline for Application to Transfer Product Licences
- 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
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Sample Documents
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ASEAN Registration of Pharmaceuticals for Human Use
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ASEAN Common Technical Dossier (ACTD)
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ASEAN Common Technical Requirements (ACTR)
- ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
- 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
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Workshop on Medicinal Products Registration 2008 - Updates & New Initiatives - Grand Copthorne Waterfront Hotel, 7 November 2008
- Topic 1: Priorty Review and Verification Route
- Topic 2: Basic of Application Filing
- Topic 3: Quality-Related Topics
- Topic 4: GMP Conformity Assessment of Overseas Manufacturing Site
- Breakout Session: Basic Understanding of Medicinal Product
- Breakout Session: Stability Study
- Breakout Session: Generic Dugs
- Breakout Session: Emerging Issues
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