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The Draft Guidelines on Safety Requirements for TMHS determine whether or not safety data is required. Under the draft, safety data is required for TMHS products particularly those containing:

  • New ingredients
  • Ingredients derived from new methods of purification or extraction or manufacturing
  • Existing ingredients /products with new applications such as new combination new dosage, new delivery system and special target population that may affect the safety of product
  • Existing ingredients with safety concern

Safety substantiation might not be required for TMHS products that do not fall under the enumeration above, or those containing ingredients with documented well established safety profile, such as traditional medicines with a long history of safe use, or health supplements which have been consumed as food or food constituent within the usage limit.
 

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