A : Table of Contents

A table of contents for the filed application should be provided.

B : Pre-Clinical Documentation
B1 : Pharmacology
B2 : Target Species Tolerance
B3 : Resistance
C: Clinical Documentation
C1: Summary of the Results and Critical Evaluation of Dose Determination and Dose Confirmation Studies and Clinical Trials
C2: Tabular Presentation of All Clinical Trials and Studies
C3: Individual Summary of the Most Important and Significant Studies
C4: Summary of Clinical Safety

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email:
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Jumaat 15 Oktober 2021, 15:58:04.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Choose Your Language

Menu Utama