(1998; 88 pages)
7.1 General considerations
Medicinal herbal products are prepared from material of plant origin which may be subject to contamination and deterioration, and may vary in composition and properties. This is in contrast to conventional pharmaceutical products, which are usually prepared from synthetic materials by means of reproducible manufacturing techniques and procedures. Furthermore, in the manufacture and quality control of medicinal herbal products, procedures and techniques are often used which are substantially different from those employed for conventional pharmaceutical products and from traditional methods of preparation.
The control of the starting materials, storage and processing assumes particular importance because of the complexity, variability and perishable natures of any medicinal herbal products and the number of potentially active ingredients present in small quantities. It is advisable that medicinal herbal products that may be widely used in the marketplace are adequately regulated so as to ensure quality, efficacy and safety of the products.
In recognition of the various legislative, socioeconomic and cultural contexts, the degree and form of management or regulation should be consistent with the specific circumstances of that country, yet adequate to ensure safety and quality of herbal medicines. In some countries different regulatory requirements for herbal medicines have been applied.
A regulatory system should be developed for manufacturers and distributors of medicinal herbal products at all levels including importers, exporters, wholesalers or retailers by licensing, registration or other means. The system should allow for periodic review.