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October 2021

Pharmacol Res. 1997 May; 35(5): 355-62.

Herbal medicines in European regulation.

Benzi G, Ceci A.

European Agency for the Evaluation of Medicinal Products (EMEA), London, UK.

Herbal medicines are assuming large use in the primary healthcare of individuals and communities consistently with the growing interest in traditional and alternative systems of medicine in many developed countries. Consumer surveys show a positive public attitude to complementary medicine. The regulation of herbal medicines is characterized by large differences depending on the ethnological, medical, and historical background of each country. The WHO Guidelines for the Assessment of Herbal Remedies, adopted by the International Conference of Drug Regulatory Authorities (Ottawa, October 1991), contain the basic elements of legislation designed to assist those countries wishing to develop an appropriate legislation and registration procedure for herbal medicines used. The WHO suggested that the different States should be urged: to give correct importance concerning the utilization of their traditional systems of medicine; to make a systematic inventory and assessment of the medical plants used by traditional practitioners and by the population; to intensify activities leading to cooperation between those providing traditional medicine and modern healthcare, respectively, especially as regards the use of scientifically proven, safe and effective traditional remedies. The goals of these suggestions are to facilitate the scientific evaluation and the eventual integration of traditional medicine into the national healthcare system, critically assisting an eventual rational use of traditional medicine through development of technical guidelines and international standards.


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