Natural Products

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•  Traditional medicine (as defined under the Control of Drugs and Cosmetics Regulations 1984):

Any product used in the practice of indigenous medicine, in which the drug consist solely of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and a homeopathic medicine. It shall not include any sterile preparation, vaccines, any substance derived human parts, any isolated and characterized chemical substances.  

•  Finished Herbal Product

Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb is used, the term “mixture herbal product” can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture herbal products to which chemically defined active substance have been added, including synthetic compounds and/ isolated constituents from herbal materials, are not considered to be herbal.

•  Herbal Remedy

Any drug consisting of a substance or a mixture of substances produced by drying, crushing or comminuting, but without subjecting to any other process, a natural substance or substances of plant, animal or mineral origin, or any part of such substance or substances.

•  Homeopathic Medicine

Any pharmaceutical dosage form used in the homeopathic therapeutic system in which diseases are treated by the use of minute amounts as of such substances which are capable of producing in healthy persons symptoms similar to those of the disease being treated.

For details, please refer to  Appendix 5: Guidelines for Registration of Natural Products Drug Registration Guidance Documents (DRGD) E-Book

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  • Last Modified: Isnin 06 Disember 2021, 15:06:23.
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