Furthermore in order to provide a specific framework for the registration of herbs and botanical preparations, a concept of review involving ‘Standardized Drug Monographs’ (SDM) has been proposed to facilitate registration of those drugs containing herbs that meet requirements of the monographs. Products making reference to such an SDM would require less individual premarket scrutiny on a product-by-product basis and would result in more rapid issuance of DIN, but would be balanced with additional post-market compliance monitoring and activity. Combinations of herbs outlined in such monographs would be accepted if justified on sound therapeutic principles. Claims in respect of prevention or treatment of serious diseases and those which are inappropriate for self-diagnosis and treatment are prohibited within this procedure. The review of DIN applications involving SDMs should enable a manufacturer to certify that products meet the conditions outlined in the SDM.

In October 1990, guidelines on ‘Traditional Herbal Medicines’ were published by the Health Protection Branch, by authority of the Minister of National Health and Welfare, to assist manufacturers in completing applications for DIN and in labelling products that fall within the category of Traditional Herbal Medicine (THM) as outlined in the information letter on 5 January 1990.

A site licence is required to manufacture, package, label and import for sale any natural health product. The manufacturing has to be done in conformity with GMP to ensure product safety and quality, including appropriate standards and practices regarding product manufacture, storage, handling and distribution. GMP covers specifications on premises and equipment, personnel, sanitation programme, operational procedures, quality assurance, stability studies, record keeping, lot or batch sampling and recall reporting. Adverse drug reaction reporting is statutory based on risk assessment and the corresponding management of risks so that advisories, where appropriate, to the public could be issued. The Natural Health Products regulations require that product licence holders monitor all adverse reactions and report serious adverse reactions to Health Canada.

In case of non-traditional products, clinical trials are required to establish the product’s clinical, pharmacological or pharmacodynamic effects to identify any adverse events related to its use, to study its absorption, distribution, metabolism and excretion and to determine its safety and efficacy.

Labelling requirements are very stringent to enable consumers to make informed choices. A label should include the product name, ingredients and composition, quantity of product in the bottle, recommended conditions of use, health claim, dosage form, dose, route of administration, any cautionary statements, contraindications, ADR and storage conditions.

Applications for traditional medicine manufacture must include a draft version of the label with a clear claim or indication for the use of the traditional herbal medicine. The claim should be supported by references. If an SDM is available for an herb, and if the proposed claims are within the scope of the monograph, a statement to this effect is an acceptable replacement for other references. Terms such as tonic, supplement, purifier, depurative, and similar wordings are not accepted. Some combinations of herbs that seem illogical, e.g., diuretics combined with laxatives and those with contradictory effects are regarded as questionable.

The assessment is primarily based on traditional references for efficacy and dosage. The claims are restricted to those that are acceptable for self-monitoring. If there are safety concerns, modern research will be taken into account instead of traditional references.