Step 2 of 4 : Submission for New Product Registration

  1. 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.
  2. 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. 
  3. Applicant shall ensure that you have clicked on the appropriate section of the display panel and fill the correct application form. 
  4. 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. 
  5. 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.

Submission Guide

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.

Submission Guide

Part II

Section P - Product

Section S - Substances

Submit Part II Information.

Submission Guide

Part III

Non-Clinical Documentation, Non-Clinical Overview, Non-Clinical Written & Tabulated Summaries, Non-Clinical Study Reports & List of Key Literature References

Not Applicable for Generic Medicine

Not Applicable for
Natural Products

Part IV

Clinical Documentation, Clinical Overview, Clinical Summary, Tabular Listing of all Clinical Studies, Clinical Study Reports & Section F

Not Applicable for Generic Medicine

Not Applicable for
Natural Products

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Tuesday 15 October 2019, 16:40:54.
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