Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)
Table of Contents
View the documentForeword
Open this folder and view contents1. Introduction
Open this folder and view contents2. Goals and objectives of the guidelines
View the document3. Definitions
Open this folder and view contents4. National policy development
Open this folder and view contents5. Development of a national programme on herbal medicines
Open this folder and view contents6. Regulation of practitioners
Close this folder7. Regulation of the manufacture and distribution of medicinal herbal products
View the document7.1 General considerations
View the document7.2 Good manufacturing practices (GMP)
View the document7.3 Training of regulatory staff
View the document7.4 WHO certification scheme on the quality of pharmaceutical products moving in international commerce
Open this folder and view contents8. Regulation of herbal medicines
View the document9. Use of the guidelines
View the documentAnnex 1: Report of the meeting of the working group on herbal medicines
View the documentAnnex 2: List of temporary advisers, consultants, observers and secretariat
View the documentAnnex 3: Agenda
View the documentAnnex 4: Opening Speech of Dr S.T. Han, WHO Regional Director for the Western Pacific Region Working Group on Herbal Medicines, 8 December 1997, Manila, Philippines
View the documentAnnex 5: Closing Remarks of Dr S.T. Han, WHO Regional Director for the Western Pacific Working Group on Herbal Medicines, 12 December 1997, Manila, Philippines
View the documentReferences
 

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.

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