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Guidelines for the Appropriate use of Herbal Medicines
(88 pages)


Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use of herbal medicines in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade.
The report has two parts. The guidelines are presented in the first, which opens with background information about the objectives of national policies aimed at the promotion, development, and regulation of herbal medicines. The need to define the place of traditional care within modern health systems is discussed together with the importance of conserving plant species. Against this background, the guidelines are presented in five chapters. General guidelines for the development of a national policy are followed by advice on the process by which national policies are developed and implemented. Ten specific issues that need to be addressed are identified and discussed.
Subsequent chapters outline legal and other options available for the regulation of practitioners, manufacturers and the distribution system. The guidelines conclude with a description of the different regulatory procedures that can be applied to raw plant materials, processed plant materials, and medicinal herbal products. The regulation of medicinal herbal products is discussed in terms of detailed requirements for the registration of both traditionally used products and new products. The chapter also includes advice on labelling requirements, the responsible government agency, and establishment of a system for monitoring adverse reactions.
The second part includes a summary of the working group's deliberations and conclusions, followed by brief reports from 14 Western Pacific countries, which document the importance of herbal medicines and summarize existing systems for their regulation and control.

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
Open this folder and view contents7. Regulation of the manufacture and distribution of medicinal herbal products
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

Guidelines for the Appropriate use of Herbal Medicines

WHO Regional Publications, Western Pacific Series No. 23

World Health Organization
Regional Office for the Western Pacific
Manila, 1998

WHO Library Cataloguing in Publication Data

Guidelines for the appropriate use of herbal medicines (WHO regional publications. Western Pacific series; no. 23)

1. Medicine, Herbal - standard
2. Drug monitoring
3. Guidelines
I. Series

ISBN 92 9061 124 3

The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization, Geneva, Switzerland or to the Regional Office for the Western Pacific, Manila, Philippines, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available.

© World Health Organization 1998

Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved.

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.


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Last updated: May 4, 2012