This should cover all important aspects of efficacy assessment. A review of the relevant literature should be carried out and copies provided of the original articles or proper references made to them. Research studies, if they exist, should be taken into account.
The pharmacological and clinical effects of the active ingredients and, if known, their constituents with therapeutic activity should be specified or described.
Evidence required to support indications
The indication(s) for the use of the medicine should be specified. In the case of traditional medicines, the requirements for proof of efficacy should depend on the kind of indication. For treatment of minor disorders and for non-specific indications, some relaxation in requirements for proof of efficacy may be justified, taking into account the extent of traditional use. The same considerations may apply to prophylactic use. Individual experiences recorded in reports from physicians, traditional health practitioners or treated patients should be taken into account.
Where traditional use has not been established, appropriate clinical evidence should be required.
As many herbal remedies consist of a combination of several active ingredients, and as experience of the use of traditional remedies is often based on combination products, assessment should differentiate between old and new combination products. Identical requirements for the assessment of old and new combinations would result in inappropriate assessment of certain traditional medicines.
In the case of traditionally used combination products, the documentation of traditional use (such as classical texts of Ayurveda, traditional Chinese medicine, Unani, Siddha) and experience may serve as evidence of efficacy.
An explanation of a new combination of well-known substances, including effective dose ranges and compatibility, should be required in addition to the documentation of traditional knowledge of each single ingredient. Each active ingredient must contribute to the efficacy of the medicine.
Clinical studies may be required to justify the efficacy of a new ingredient and its positive effect on the total combination.