Step 2 of 4 : Submission for New Biologic Product Registration
- Online application forms are available for different product categories in the QUEST system. This submission guide is arranged according to several parts in QUEST3+ online form.
- Applicant shall follow and comply with all requirements in the online application forms as well as any supplementary documentation requested by the Authority, whichever it may deems fit.
- Applicant shall ensure that you have clicked on the appropriate section of the display panel and fill the correct application form.
- Applicants are advised to read the explanatory notes in this appendix, as well as relevant ASEAN or ICH guidelines and checklists, for full information on requirement for product registration. In order to facilitate the evaluation process the Authority, applicants shall conform to these guidelines as well as the main guidance document.
- The Authority reserves the right to request for supplementary information in certain cases.
Product Validation
Product Name, Dosage Form, Active Ingredient, Excipient and Other Information
Submit Product Validation.
Part I
Section A - Product Particulars
Section B - Product Formula
Section C - Particulars of packing
Section D - Label , Proposed Package Insert & PIL/RiMUP
Section E - Supplementary Documentation
Submit Part I Information.
Part II
Section P - Product
Section S - Substances
Submit Part II Information.
Part III
Non-Clinical Documentation, Non-Clinical Overview, Non-Clinical Written & Tabulated Summaries, Non-Clinical Study Reports & List of Key Literature References
Submit Part III Information.
Part IV
Clinical Documentation, Clinical Overview, Clinical Summary, Tabular Listing of all Clinical Studies, Clinical Study Reports & Section F
Submit Part IV Information.