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Guidance documents for therapeutic products

Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products.

Product registration and post approval variation

Main guidance

Appendices

  1. Patent Declaration Forms 431 KB
  2. ICH CTD checklists
  3. ACTD checklists
  4. Sample Verification Document for Translator7 KB
  5. Target Processing Timelines171 KB
  6. Guideline on Submission for Non-Prescription Therapeutic Products165 KB
  7. Points to Consider for Singapore Labelling152 KB 

  8. Guideline on the Registration of Human Plasma-derived Therapeutic Products79 KB

 9. Guideline on the Registration of Human Therapeutic Products Containing Materials of Animal Origin219 KB

10. Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications95 KB

11. Guidance on Drug Master File180 KB (updated 20 Aug 21)

12. MIV self-guided tool for post-approval Variation Selection (updated 20 Aug 21)

13. Guidance on MIV Applications for Chemical Therapeutic Products980 KB (updated 20 Aug 21)

14. Guidance on MIV Applications for Biological Therapeutic Products689 KB (updated 20 Aug 21)

15. Guidance on Registration of Biosimilar Products254 KB

16. Guideline on Submission Requirements for Risk Management Plan Documents166 KB

17. Guideline on PRISM Submission2144 KB 

18. Confirmation of Quality Dossiers with Reference Agency's Approval357 KB (updated 20 Aug 21)

Retention on Therapeutic Product Register

Change of registrant

ASEAN Common Technical Dossier (ACTD)

ASEAN Registration of Pharmaceuticals for Human Use

ASEAN Common Technical Requirements (ACTR)

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for Therapeutic Products

Reporting of Therapeutic Product Defects and Recall of Therapeutic Products

Clinical trials of therapeutic products

Refer to our clinical trials section for the guidance documents.

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