• 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.


Strength of active  ingredient :

  • To enter the content of active ingredients (numerical) and then select the weights and measures from the given list.
  • The content of ingredients shall be expressed as appropriate in the following manner:                              a)  quantity per dose unit (e.g. for unit dose formulations - tablet, capsule, lozenge, etc.)  b)  percentage composition - %w/w, %w/v, %v/v, etc.       c)  weight per ml. (e.g. for solutions, suspension etc.)
  • Quantity (percentage or amount) per measured dose (e.g. oral liquids, drops, etc.)
  • Metric weights and measures shall be used.

  • 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:

 a) Product containing new single ingredient:                                   
  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. 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.

 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.

            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)

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  • Phone: +603-7883 5400




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