Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)

Resumen

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.

Índice de contenido

	Foreword
	1. Introduction
		1.1 The role of herbal medicines
		1.2 WHO's policy on herbal medicines
		1.3 The need for the guidelines on appropriate use of herbal medicines
	2. Goals and objectives of the guidelines
		2.1 Goals
		2.2 Objectives
	3. Definitions
	4. National policy development
		4.1 Process for the development of a policy on herbal medicine
		4.2 Issues to be included in the policy
	5. Development of a national programme on herbal medicines
		5.1 National management body for the herbal medicine programme
		5.2 Use of herbal medicines in health care
		5.3 Research on herbal medicines
		5.4 Preparation of information on medicinal plants
		5.5 Conservation of medicinal plants
		5.6 Training and education
		5.7 Collection and exchange of information on herbal medicines
	6. Regulation of practitioners
		6.1 Options
		6.2 Examination
	7. Regulation of the manufacture and distribution of medicinal herbal products
		7.1 General considerations
		7.2 Good manufacturing practices (GMP)
		7.3 Training of regulatory staff
		7.4 WHO certification scheme on the quality of pharmaceutical products moving in international commerce
	8. Regulation of herbal medicines
		8.1 General considerations
		8.2 Requirements for raw plant materials
		8.3 Requirements for processed plant materials
		8.4 Requirements for medicinal herbal products
		8.5 Label requirements
		8.6 Responsible government agency for regulation
		8.7 Promotion and advertisement of herbal medicines
		8.8 Monitoring of adverse reactions to herbal medicines
	9. Use of the guidelines
	Annex 1: Report of the meeting of the working group on herbal medicines
	Annex 2: List of temporary advisers, consultants, observers and secretariat
	Annex 3: Agenda
	Annex 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
	Annex 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
	References

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.

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