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Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(94 pages)


Sets out detailed guidelines for conducting scientific research on the safety and efficacy of herbal medicines. The guidelines, which reflect the consensus reached by 17 experts in pharmacology, biochemistry, and traditional medicine, respond to the need to assure the safety of widely used herbal medicines while also facilitating the search for new pharmaceutical products. Specific research criteria are covered together with general principles of investigation, including ethical concerns.
The book has three parts. The first discusses the special properties of herbal medicines that need to be considered when designing research protocols. The second part provides detailed guidance on the objectives of research, the contents of a research protocol, and the methods of investigation for non-clinical studies and for Phase I to Phase IV clinical trials.
The third part, which forms the core of the book, presents three sets of research guidelines: for quality specifications of plant materials and preparations, for pharmacodynamic and general pharmacological studies of herbal medicines, and for toxicity investigation of herbal medicines. Topics covered range from the information required to establish the identity and quality of plant materials or preparations, through the selection of appropriate test systems for pharmacodynamic studies, to detailed advice on the many different tests, examinations, observations, and experimental procedures required, in experimental animals and controls, to establish the safety of herbal medicines.
The guidelines are intended to facilitate the work of research scientists and clinicians while also furnishing some reference points for the governmental, industrial, and non-profit organizations providing financial support.

Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents3. RESEARCH STUDIES
Open this folder and view contents4. USING THE GUIDELINES
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY

Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

World Health Organization
Regional Office for the Western Pacific

The World Health Organization is a specialized agency of the United Nations with primary responsibility for international health matters and public health. Through this organization, which was created in 1948, the health professions of some 180 countries exchange their knowledge and experience with the aim of making possible the attainment by all citizens of the world by the year 2000 of a level of health that will permit them to lead a socially and economically productive life.

By means of direct technical cooperation with its Member States, and by stimulating such cooperation among them, WHO promotes the development of comprehensive health services, the prevention and control of diseases, the improvement of environmental conditions, the development of human resources for health, the coordination and development of biomedical and health services research, and the planning and implementation of health programmes.

These broad fields of endeavour encompass a wide variety of activities, such as developing systems of primary health care that reach the whole population of Member countries; promoting the health of mothers and children; combating malnutrition; controlling malaria and other communicable diseases including tuberculosis and leprosy; coordinating the global strategy for the prevention and control of AIDS; having achieved the eradication of smallpox, promoting mass immunization against a number of other preventable diseases; improving mental health; providing safe water supplies; and training health personnel of all categories.

Progress towards better health throughout the world also demands international cooperation in such matters as establishing standards for biological substances, pesticides and pharmaceuticals; formulating environmental health criteria; recommending international nonproprietary names for drugs; administering the International Health Regulations; revising the International Statistical Classification of Diseases and Related Health Problems; and collecting and disseminating health statistical information.

Reflecting the concerns and priorities of the Organization and its Member States, WHO publications provide authoritative information and guidance aimed at promoting and protecting health and preventing and controlling disease.

WHO Library Cataloguing in Publication Data

Research guidelines for evaluating the safety and efficacy of herbal medicines

1. Evaluation studies

2. Medicine, Research

3. Plants, Medicinal

4. Research


ISBN 92 9061 110 3

(NLM Classification: WB 925)

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 1993

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