WHO has recognized the contribution and value of herbal medicines used by a large segment of the world’s population. Extensive usage of medicinal plants worldwide has raised concerns of safety, efficacy and quality control of herbal medicines and traditional procedure-based therapies. To enable legislation concerning procedures for registration of herbal medicines, governments need to draft national policies to develop regulatory and legal reforms to ensure good practice and to extend primary health care coverage, while ensuring the authenticity, safety and efficacy of these medicines. Such initiatives shall result in approval of safe and clinically effective drugs by endorsing and encouraging research on herbal medicines for improved utilization by the public.

Some of the significant events that led to the initiation of regulatory changes in herbal drug trade are the following:

The World Health Assembly (WHA) adopted a number of resolutions drawing attention to the fact that a large section of the population in many developing countries still relies on traditional medicine, and that the work force represented by traditional practitioners is a potentially important resource for primary health care. In 1978, the Declaration of Alma-Ata recommended, inter alia, the inclusion of proven traditional remedies into national drug policies and regulatory measures.

WHO’s policy on traditional medicine was presented in the Director General’s report on Traditional Medicine and Modern Health Care to the 44th World Health Assembly 1991. Based on the relevant WHA resolutions, the major objectives of the programme were facilitation of integration of traditional medicine into national health care systems, development of technical guidelines for promotion of rational use of traditional medicine and dissemination of information on various forms of traditional medicine.

The WHA 1989 resolutions urged member states to

• make a comprehensive evaluation of their traditional systems of medicine;
• make a systematic inventory and assessment (preclinical and clinical) of the medicinal plants used by traditional practitioners and by the population;
• introduce measures for the regulation and control of medicinal plant products and for the establishment and maintenance of suitable standards;
• identify those medicinal plants, or remedies derived from them, which have a satisfactory efficacy/side-effect ratio and which should be included in national formularies or pharmacopoeias.

Herbal medicines were included in the International Conference on Drug Regulatory Authorities (ICDRA) since the fourth conference in 1986.

The fourth and fifth ICDRA in 1986 and 1989, respectively, held workshops on the regulation of herbal medicines moving in international commerce and concluded with proposals for WHO to consider preparing model guidelines containing basic elements of legislation and registration for herbal medicines.

A WHO consultation in Munich, Germany, June 1991, drafted guidelines for the assessment of herbal medicines which were adopted for general use by the sixth ICDRA in Ottawa, October 1991. These guidelines define basic criteria for the evaluation of quality, safety and efficacy of herbal medicines to assist national regulatory authorities, scientific organizations and manufacturers to undertake an assessment of the documentation, of submissions and/or dossiers in respect of such products. The WHO guidelines are intended to facilitate the work of regulatory authorities, scientific bodies and industry in the development, assessment and registration of herbal medicines, reflecting scientific results which could be the basis for future classification of herbal medicines and would also accommodate cross-cultural transfer of traditional herbal medicinal knowledge between different parts of the world.

In 1994, the regional office for the Eastern Mediterranean published guidelines for Formulation of National Policy on Herbal Medicines recommending countries to establish a National Expert Committee to identify the steps and plans needed to formulate a national policy on herbal medicine and to develop, direct and monitor the various phases of its implementation.

WHO regional office for the Western Pacific, in 1992, organized a meeting of experts to develop guidelines for research on herbal medicines. Basic scientific principles and special requirements related to their use in traditional practice are incorporated in these guidelines, the main objectives of which are to ensure their safety and efficacy, to promote their rational use, and to provide research criteria for their evaluation. These guidelines provide a basis for member states to develop their own research guidelines, and for exchange of research-related information for generation of data for reliable validation of herbal medicines.

In 1997, with the support of the National Center of Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD, USA, a WHO informal discussion developed draft guidelines for methodology on research and evaluation of traditional medicine. Since then the draft has been revised four times. The guidelines finalized at a WHO consultation in April 2000, in Hong Kong focus on the current major debates on safety and efficacy of traditional medicine and are intended to raise and answer some challenging questions concerning the evidence base. They clarify certain commonly used but unclear definitions. The guidelines present some national regulations for the evaluation of herbal medicine, and also recommend new approaches for carrying out clinical research.

The summary and recommendations of the sixth ICDRA prompted WHO as part of its Traditional Medicine programme to prepare a technical document entitled ‘WHO Monographs on Selected Medicinal Plants’ on the basis of the Guidelines for the Assessment of Herbal Medicines. The purpose of this document was to provide scientific information on the safety, efficacy and quality control of widely used medicinal plants and to provide models for member states to develop their own monographs on these and additional herbal medicines.

After discussion and review at the WHO consultation in Munich, Germany in 1996, 28 monographs were adapted and presented at the eighth ICDRA meeting in Bahrain, November, 1996. Another 32 monographs are being prepared. The information in the monographs includes two parts: Part I consists of summaries of the botanical characteristics, major active chemical constituents and quality control of each plant; Part II consists of summaries of clinical applications, pharmacology, posology, possible contraindications and precautions and potential adverse reactions.

Based on national experiences in formulating policies on traditional medicinal products from 52 member states, the WHO has brought out a document reviewing the regulatory situation of herbal medicines in these countries in order to facilitate information exchange on these subjects among the member states and to assist introduction of measures for the registration and regulation of herbal medicines.