General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Open this folder and view contents4. Other Issues and Considerations
View the documentReferences
Open this folder and view contentsAnnexes
Close this folderAnnex I. Guidelines for the Assessment of Herbal Medicinesa
View the documentIntroduction
View the documentAssessment of Quality
View the documentAssessment of Safety
View the documentAssessment of Efficacy
View the documentIntended Use
View the documentUtilization of these Guidelines
Open this folder and view contentsAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Open this folder and view contentsAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

Introduction

For the purpose of these guidelines, herbal medicines are defined as follows:

Finished, labelled medicinal products that contain as active ingredients aerial or underground parts of plants, or other plant material, or combinations thereof, whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this nature. Herbal medicines may contain excipients in addition to the active ingredients. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants, are not considered to be herbal medicines.

Exceptionally, in some countries herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin.

The past decade has seen a significant increase in the use of herbal medicines. As a result of WHO’s promotion of traditional medicine, countries have been seeking the assistance of the Organization in identifying safe and effective herbal medicines for use in national health care systems.

In 1991, the Director-General of WHO, in a report to the Forty-fourth World Health Assembly, emphasized the great importance of medicinal plants to the health of individuals and communities. Earlier, in 1978, the Thirty-first World Health Assembly had adopted a resolution (WHA31.33) that called on the Director-General to compile and periodically update a therapeutic classification of medicinal plants, related to the therapeutic classification of all drugs; subsequently, resolution WHA40.33, adopted in 1987, urged Member States to ensure quality control of drugs derived from traditional plant remedies by using modern techniques and applying suitable standards and good manufacturing practices; and resolution WHA42.43, of 1989, urged Member States to introduce measures for the regulation and control of medicinal plant products and for the establishment and maintenance of suitable standards. Moreover, the International Conference on Primary Health Care, held in Alma-Ata, USSR, in 1978, recommended, inter alia, the accommodation of proven traditional remedies in national drug policies and regulatory measures.

In developed countries, a resurgence of interest in herbal medicines has resulted from the preference of many consumers for products of natural origin. In addition, manufactured herbal medicines often follow in the wake of migrants from countries where traditional medicines play an important role.

In both developed and developing countries, consumers and health care providers need to be supplied with up-to-date and authoritative information on the beneficial properties, and possible harmful effects, of all herbal medicines.

The Fourth International Conference of Drug Regulatory Authorities, held in Tokyo in 1986, organized a workshop on the regulation of herbal medicines moving in international commerce. Another workshop on the same subject was held as part of the Fifth International Conference of Drug Regulatory Authorities, held in Paris in 1989. Both workshops confined their considerations to the commercial exploitation of traditional medicines through over-the-counter labelled products. The Paris meeting concluded that the World Health Organization should consider preparing model guidelines containing basic elements of legislation designed to assist those countries wishing to develop appropriate legislation and registration.

The objective of these guidelines is to define basic criteria for the evaluation of quality, safety and efficacy of herbal medicines and thereby to assist national regulatory authorities, scientific organizations and manufacturers to undertake an assessment of the documentation/submissions/dossiers in respect of such products. As a general rule in this assessment, traditional experience means that long-term use as well as the medical, historical and ethnological background of those products shall be taken into account. The definition of long-term use may vary according to the country but should be at least several decades. Therefore, the assessment should take into account a description in the medical/pharmaceutical literature or similar sources, or a documentation of knowledge on the application of a herbal medicine without a clearly defined time limitation. Marketing authorizations for similar products should be taken into account.

Prolonged and apparently uneventful use of a substance usually offers testimony of its safety. In a few instances, however, investigation of the potential toxicity of naturally occurring substances widely used as ingredients in these preparations has revealed previously unsuspected potential for systematic toxicity, carcinogenicity and teratogenicity. Regulatory authorities need to be quickly and reliably informed of these findings. They should also have the authority to respond promptly to such alerts, either by withdrawing or varying the licences of registered products containing suspect substances, or by rescheduling the substances to limit their use to medical prescription.

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