Traditional Chinese Medicine Ingredients (TCMI)

What is it used for?

Single ingredient products prepared as per a TCM referenced text listed in this reference OR products whose combination of ingredients and preparation is identical to a base formula in the TCM referenced text listed in this reference:

Remedy/Product/Preparation based on the theory of Traditional Chinese Medicine.

Products whose combination of ingredients and/or preparation is not identical to a base formula in the TCM referenced text listed in this reference:

Combination of Traditional Chinese Medicine Ingredients.

What this guide covers

• By submitting a web-based product documentation form referencing this reference to the source authority, the applicant is attesting that the product will fully comply with the recommended conditions of use outlined in this reference, including the conditions found in the Traditional Chinese Medicine (TCM) referenced texts (those provided in the reference section below) when more restrictive and/or not specified in this reference. The conditions of use include methods of preparations, source materials, doses, directions for use, durations of use, combinations of active ingredients, risk statements, and the theory of TCM.

• All ingredients on this reference are pharmacopoeial ingredients and all pharmacopoeial ingredients must be prepared in accordance with the most recent edition of an accepted pharmacopoeia (e.g., the Pharmacopoeia of the People's Republic of China). Ingredients not prepared according to pharmacopoeial standards are not supported by this reference.

• Any substitution of different species, subspecies or variety (i.e. proper names), despite the same common name and/or pharmacopoeial name, is considered fundamental change and not an amendment. Those products with different proper names will require a separate product authorization (source product registration). For example, for Gan cao, if a source product registration was obtained with the proper name Glycyrrhiza glabra, the proper name cannot be substituted with Glycyrrhiza inflata even if captured under the same pharmacopoeial name (Radix et Rhizoma Glycyrrhiza). Another source product registration should be obtained for Glycyrrhiza inflata - Gan cao.

Restrictions when this reference is combined with other references (source review category II and III):

• Stimulant laxative and/or diuretic ingredients from Table 2 (Appendix I) cannot be combined with any other laxative and/or diuretic ingredients at Class II since the dose information is not captured by this reference. These combinations may be submitted as a source review category III.

• Any combinations of TCM ingredients or TCM ingredients with non-TCM ingredients with potential additive glucose modifying effects and/or blood pressure-lowering effects and/or sedative effects should be submitted as a source review category III.

Who does this guide cover?

Adults 18 years and older

How is it taken?

• Oral

• Topical

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Acceptable dosage forms for oral or topical route of administration are indicated in the dosage form drop-down list of the web-based product documentation form.

Quantities

• The quantities of active ingredient(s) must not exceed the maximum daily dose specified by TCM referenced texts listed in this reference, taking into account potential additive effects between ingredients with similar actions or properties.

• Acute (high-dose) uses described in TCM reference texts are not permitted where such dose are associated with the treatment of serious conditions or an increased risk to health, in accordance with the Pathway for Licensing supplements used as Traditional Medicines.

• Products providing more than 1 g of Piper longum are excluded from this reference.

• For topical products:

  • The quantity of the active ingredient should be entered as a percentage (%) in the finished product. Where the active ingredient is an extract (e.g., extract dry, decoction, decoction concentrate), the extract ratio and quantity crude equivalent (QCE) should both be manually entered as the product documentation form cannot adequately calculate the extract ratio from the active ingredient quantity and QCE. The QCE should reflect the QCE that is present in 1 g (or mL) of the finished product.

  • On the product documentation form, quantities can be expressed as percentage weight by weight (% w/w), percentage weight by volume (% w/v) or percentage volume by volume (% v/v), depending on the product formulation. On the product label, quantities can also be expressed in other equivalent concentration units (e.g., mg/mL).

How is it used?

All products

Use/Take as directed by a healthcare professional.¹ And Any additional direction of use statement as specified by referenced texts.

¹ Note: If the directions of use and duration of use for the product are specified, the direction of use statement ‘Use/Take as directed by a healthcare professional’ can be replaced on the label to a specific statement followed by ‘or as directed by a health care practitioner’ (e.g. Take X scoop(s) of granules, X time(s) per day or as directed by a health care practitioner. Mix in warm water. Ask a health care practitioner for use beyond X weeks). If the direction for use and the duration of use are not specified, the general direction of use ‘Use/Take as directed by a health care practitioner’ is required.

How long is it used?

Oral products containing stimulants laxatives from Table 2

Ask a healthcare professional for use beyond 7 days.

Oral products containing Herba Ephedra

Ask a healthcare professional for use beyond 7 days (source authority Ephedra reference).

Oral products containing any Glycyrrhiza species

Ask a healthcare professional for use beyond 4 weeks (source authority Licorice reference).

Warnings and precautions

All products

• Stop use and ask a healthcare professional if symptoms persist or worsen, or if new symptoms develop.

• Ask a healthcare professional before use if you are taking prescription medications.

• Ask a healthcare professional before use if you have serious or major conditions, any type of acute infection, deficiency or excess.

And

Any additional risk statement not covered by the above statements as specified by referenced texts.

Products containing any Angelica species

When using this product avoid exposure to the sun.

All topical products

For external use only.

Mel (Apis mellifera) & Radix et Rhizoma Glycyrrhizae Praeparata cum Melle (Glycyrrhiza glabra, Glycyrrhiza inflata, Glycyrrhiza uralensis)

This product contains honey.

When should it be avoided?

All products

Do not use if you are pregnant or breastfeeding. And Any additional risk statement not covered by the above statement as specified by referenced texts.

Oral products containing two or more diuretics from Table 2 (total QCE (Quantity Crude Equivalent): > 100 mg/day for powdered and ethanolic extracts or > 300 mg/day for decoction and decoction concentrate)

Do not use if you have heart disease, high or low blood pressure, kidney or liver disorder, diabetes or edema (swelling of hands, face and feet) or are taking other products containing diuretics.

Possible side effects

All products

As specified by referenced texts.

Oral products containing any diuretic from Table 2 (total QCE: > 100 mg/day for powdered and ethanolic extracts or > 300 mg/day for decoction and decoction concentrate)

When using this product diuretic effect may occur.

Oral products containing two or more diuretics from Table 2 (total QCE: > 100 mg/day for powdered and ethanolic extracts or > 300 mg/day for decoction and decoction concentrate)

Stop use and ask a healthcare professional immediately if dizziness, confusion, muscle weakness or pain, abnormal heart beat and/or difficulty breathing occur.

In addition to the risk statements listed above, risk statements (caution & warning, contraindication, known adverse reaction) from the source authority single ingredient references listed below are required.

¹ The symbols used in the tables are defined as follows:

• ✓ = risk statements from the associated single reference are required.

• X = statements are already covered by the general risk statements listed above.

• N/A = no risk statement on the associated single reference.

In addition to the risk statements listed above, risk statements listed in source ingredient database for the active ingredients below are required.

Storage

• As specified by referenced texts.

• Must be established in accordance with the requirements described in the applicable product regulations (NHPR).

Conditions for combined preparations

(Combination of ingredients not supported by this reference may be submitted as a source review category III)

• Stimulant laxative ingredients from Table 2 (Appendix I) may not be combined together and/or with diuretics and/or with the active ingredient Gan cao or Zhi gan cao (Glycyrrhiza glabra, G. inflata, G. uralensis) due to potential of electrolyte imbalance.

• Not more than 1 diuretic from Table 2 (Appendix I) may be combined with the active ingredient Gan cao or Zhi gan cao due to potential of electrolyte imbalance.

• Not more than 3 diuretics from Table 2 (Appendix I) may be combined together.

• Ingredients indicated as mutually incompatible or antagonistic in the TCM referenced texts should not be combined.

Appendix 1

*The Pharmacopoeial name is the ingredient name found in the source ingredient database. **Products providing more than 1 g of Piper longum are excluded from this reference

*The Pharmacopoeial name is the ingredient name found in the source ingredient database.

*The Pharmacopoeial name is the ingredient name found in the source ingredient database.

*The Pharmacopoeial name is the ingredient name found in the source ingredient database.