Active Ingredient(s)

3.1 Active Ingredient Name

3.2 Salt Form

3.3 Strength of Active Ingredient (Quantity unit/ dose)

3.4 Strength Salt-Free

3.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)

3.6 Form of Substance

3.7 Remarks (if any)

3.8 Status

• Listed active ingredients can be checked through http://npra.moh.gov.my/ of product search. Ingredients not listed will require safety and/or efficacy data evaluation prior to addition to this list.

• Substances that are included in the formulation as active ingredients must make a contribution to the proposed indications for the product.

• Please specify the source such as animal, plant, synthetic or others.

• Please check whether the product contains active ingredients listed in the PROTECTED/ ENDANGERED WILDLIFE OR BOTANICAL SPECIES as in the DRGD. The applicant shall contact the appointed department as listed in DRGD to obtain the necessary permit / license.

Traditional Medicines:

  • Effective from 1 December 2007, premixed ingredient(s) shall not be used in a traditional product formulation, as directed in circular Bil (71) dlm BPFK/02/5/1.3.
  • Please ensure that only active substances that are permitted and no substance are prohibited. Please refer to Appendix 5 under 2.1.3 'Prohibited / Banned ingredients' in DRGD.
  • Please ensure the Aristolochic Acid test from governmental doping center is submitted in F12 for products containing active ingredients listed in List A - Botanicals Known or Suspected to contain Aristolochic Acid and List B - Botanicals which may be adulterated with Aristolochic Acid.
  • Please take note this specific ingredients not allowed to be registered under Traditional Medicine:

       a) Crinis Carbonisatus (Carbonised human hair)       b) Human Placenta

  • For new active ingredients or new combination products, the following information shall be required:

 

  1. a) Product containing new single ingredient:
  2. i) Extract form

- Information on the taxonomy of the ingredient;

                              - Techniques and methods in preparing/ processing the extract and subsequently the product;

                              -  Information on the use and safety of the ingredient and the product quality standard.

  1. ii) Powder/ Granules

                 -  Information on the taxonomy of the ingredient;

                 -  Techniques and methods in preparing/ processing the extract and subsequently the product;

                 -  Information on the use and safety of the ingredient and the product.

  1. b) Product containing multiple ingredients (contains ingredients which are known to be used traditionally):

            -  The source of the product formulation; e.g. Chinese Pharmacopoeia

            -  Proof or evidence of the use, traditionally.

           

  1. c) Product containing multiple ingredients (contains ingredients which are not known to be used traditionally):

            -  Information on the use and safety of every new ingredient;

            -  Safety data on the new formulation;

            -  Regulatory status in other countries.

 

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

Drug Registration Guidance Document (DRGD) - Appendix 8.1 List of Prohibited and Restricted Active Ingredients and Combinations.

 


How to Access Active Ingredient in QUEST3+ System ? 

Product Registration >> New Application Form >> Product Validation >> Active Ingredients

 

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

DISCLAIMER

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 :

Newsletter Subsription

Site Last Modified

  • Last Modified: Jumaat 19 Julai 2019, 16:49:18.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Menu Utama

Choose Your Language