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