Guidelines on Minimum Requirements for the Registration of Herbal Medicinal Products in the Eastern Mediterranean Region
(2006; 30 pages)

Abstract

Use of herbal medicines has also increased steadily in countries of the WHO Eastern Mediterranean Region. In some countries, for example the Islamic Republic of Iran, herbal medicines are produced locally and a large population depends on them for primary health care. In other countries, such as the United Arab Emirates, the majority of herbal products are obtained from the United States, Europe or Asia. A major problem in the evaluation of imported herbal products is that they often contain more than 10 plants, and it is very difficult to conduct testing and quality control. Another problem is that classification categories for herbal products vary from country to country; some categories include functional foods, dietary supplements and traditional medicines.

Overall, there is a lack of cooperation and information sharing regarding market control between the ministries of health of different countries in the Region. Important data related to safety, efficacy and quality control are often either insufficient or not available. In most countries, either no safety monitoring system exists or the existing system excludes herbal medicines.

Governments need to establish their national regulations on the control of imported herbal medicines through sharing experiences and harmonizing standards on safety and quality control across national boundaries.

In order to develop regional guidelines on the regulation of herbal medicines, WHO organized two regional workshops for national drug authorities. The first workshop focused on controlling the safety, quality and efficacy of herbal products, and developed draft regional guidelines on regulation of herbal medicines.

The second regional workshop reviewed the draft guidelines developed in the first workshop. The guidelines are intended to be used for the assessment of crude botanical drugs and for industrially-prepared finished products. A list of traditional herbal substances and combinations of herbal substances would facilitate both tasks.

 
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