Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products.
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
12. MIV online enquiry form
13. Guidance on MIV Applications for Chemical Therapeutic Products980 KB
14. Guidance on MIV Applications for Biological Therapeutic Products689 KB
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 (updated 31 Dec 2020)
18. Confirmation of Quality Dossiers with Reference Agency's Approval357 KB
Refer to our clinical trials section for the guidance documents.
Regulatory overview
Register your product
Apply for post-approval variation
Reclassify your product
Dealer's licensing and certification
Report adverse events
Report or recall defective products
Retail pharmacy licensing
Clinical trials
Product consultation
Advertisements and promotions
CPP and SLS
International collaboration
Guidance documents
Fees and turnaround time
PRISM (Therapeutic products)
Infosearch