WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
(2003; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Close this folder1. General introduction
View the document1.1. Background
View the document1.2. Objectives
View the document1.3. Structure
Open this folder and view contents1.4. Glossary
Open this folder and view contents2. Good agricultural practices for medicinal plants
Open this folder and view contents3. Good collection practices for medicinal plants
Open this folder and view contents4. Common technical aspects of good agricultural practices for medicinal plants and good collection practices for medicinal plants
Open this folder and view contents5. Other relevant issues
View the documentBibliography
View the documentAnnex 1. Good Agricultural Practice for Traditional Chinese Medicinal Materials, People's Republic of China
Open this folder and view contentsAnnex 2. Points to Consider on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin
View the documentAnnex 3. Good Agricultural and Collection Practices for Medicinal Plants (GACP), Japan
View the documentAnnex 4. A model structure for monographs on good agricultural practices for specific medicinal plants
View the documentAnnex 5. Sample record for cultivated medicinal plants
View the documentAnnex 6. Participants in the WHO Consultation on Good Agricultural and Field Collection Practices for Medicinal Plants
 

1.1. Background

Interest in traditional systems of medicine and, in particular, herbal medicines, has increased substantially in both developed and developing countries over the past two decades. Global and national markets for medicinal herbs have been growing rapidly, and significant economic gains are being realized. According to the Secretariat of the Convention on Biological Diversity, global sales of herbal products totalled an estimated US$ 60 000 million in 2000. As a consequence, the safety and quality of herbal medicines have become increasingly important concerns for health authorities and the public alike (1).

Some reported adverse events following the use of certain herbal medicines have been associated with a variety of possible explanations, including the inadvertent use of the wrong plant species, adulteration with undeclared other medicines and/or potent substances, contamination with undeclared toxic and/or hazardous substances, overdosage, inappropriate use by health-care providers or consumers, and interaction with other medicines, resulting in an adverse drug interaction. Among those attributable to the poor quality of finished products, some clearly result from the use of raw medicinal plant materials that are not of a sufficiently high quality standard.

The safety and quality of raw medicinal plant materials and finished products depend on factors that may be classified as intrinsic (genetic) or extrinsic (environment, collection methods, cultivation, harvest, post-harvest processing, transport and storage practices). Inadvertent contamination by microbial or chemical agents during any of the production stages can also lead to deterioration in safety and quality. Medicinal plants collected from the wild population may be contaminated by other species or plant parts through misidentification, accidental contamination or intentional adulteration, all of which may have unsafe consequences.

The collection of medicinal plants from wild populations can give rise to additional concerns related to global, regional and/or local over-harvesting, and protection of endangered species. The impact of cultivation and collection on the environment and ecological processes, and the welfare of local communities should be considered. All intellectual property rights with regard to source materials must be respected. WHO has cooperated with other United Nations specialized agencies and international organizations in dealing with the above-mentioned issues. Such cooperation will be further strengthened through the development and the updating of relevant technical guidelines in these areas.

Safety and quality assurance measures are needed to overcome these problems and to ensure a steady, affordable and sustainable supply of medicinal plant materials of good quality. In recent years, good agricultural practices have been recognized as an important tool for ensuring the safety and quality of a variety of food commodities, and many Member States have established national good agricultural practice guidelines for a range of foods. However, quality control for the cultivation and collection of medicinal plants as the raw materials for herbal medicines may be more demanding than that for food production; possibly for this reason, only China, the European Union, and Japan have recently developed guidelines on good agricultural practices for medicinal plants (Annexes 1, 2 and 3, respectively). Since their guidelines were established to meet the requirements of specific regions or countries, they may not be universally applicable or acceptable.

At a WHO Informal Meeting on Methodologies for Quality Control of Finished Herbal Products, held in Ottawa, Canada from 20 to 21 July 2001, the entire process of production of herbal medicines, from raw materials to finished herbal products, was reviewed. It was recommended that WHO should give high priority to the development of globally applicable guidelines to promote the safety and quality of medicinal plant materials through the formulation of codes for good agricultural practices and good collection practices for medicinal plants. It was envisaged that such guidelines would help to ensure safety and quality at the first and most important stage of the production of herbal medicines.

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