2017
DOI: 10.1016/j.jep.2017.06.047
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Herbal medicinal products – Evidence and tradition from a historical perspective

Abstract: When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and above the formally stipulated regulatory provisions (30 years, product reference). To this end, the scientific methods (from among the natural, life or cultural sciences), which are recognized as authoritative in each case, must be applied.

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Cited by 49 publications
(35 citation statements)
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“…A number of other authors have recently explored the problems related to clinical efficacy of herbal medicinal products (Minuz, Velo, Violi, & Ferro, ), from the point of view of clinical research (Andrew & Izzo, ; Pferschy‐Wenzig & Bauer, ; Varoni, Lodi, & Iriti, ) and regulation (Jütte et al, ). Herbal medicinal products could bring a broad range of beneficial effects, but their efficacy and safety must be assured.…”
Section: Discussionmentioning
confidence: 99%
“…A number of other authors have recently explored the problems related to clinical efficacy of herbal medicinal products (Minuz, Velo, Violi, & Ferro, ), from the point of view of clinical research (Andrew & Izzo, ; Pferschy‐Wenzig & Bauer, ; Varoni, Lodi, & Iriti, ) and regulation (Jütte et al, ). Herbal medicinal products could bring a broad range of beneficial effects, but their efficacy and safety must be assured.…”
Section: Discussionmentioning
confidence: 99%
“…Nine countries, China, Korea, India, Indonesia, Malaysia, Myanmar, Sri Lanka, Thailand, and Vietnam, have documented their National Monographs for herbal drugs, while Pharmacopeia is found in Bangladesh, India, Indonesia, Sri Lanka, Thailand, and Vietnam [66,67]. In practice, TCM is more globalized and well-documented [67][68][69][70]. In general, there is increased interest by practitioners to implement good MP management practices-this suggests an urgent need for scientific investigations to inform such a process [71][72][73][74][75].…”
Section: Rules and Structuresmentioning
confidence: 99%
“…The regulation applies to herbal products with a longstanding tradition of use, that have been on the market for at least 30 years, including 15 years in an EU member state. No special assays or trials are required to prove the safety of herbal medicines, but proof that the product is not harmful is compulsory (European Commission, 2004;Jütte et al, 2017). Since 2004, the EU Directive 2004/24/EC has been incorporated into national legal systems to increase the safety of traditional herbal medicines and to facilitate their free movement by harmonising previous national regulatory frameworks (Vlietinck et al, 2009;Jütte et al, 2017).…”
Section: Regulatory Status Of Herbal Productsmentioning
confidence: 99%
“…No special assays or trials are required to prove the safety of herbal medicines, but proof that the product is not harmful is compulsory (European Commission, 2004;Jütte et al, 2017). Since 2004, the EU Directive 2004/24/EC has been incorporated into national legal systems to increase the safety of traditional herbal medicines and to facilitate their free movement by harmonising previous national regulatory frameworks (Vlietinck et al, 2009;Jütte et al, 2017). The Herbal Medicinal Products Committee (HMPC) is the European Medicines Agency's (EMA's) committee responsible for establishing monographs on the therapeutic uses and the safety of medicinal products, with the pharmacovigilance of the marketed herbal medicines being a regulatory requirement falling under the full responsibility of manufacturers and suppliers.…”
Section: Regulatory Status Of Herbal Productsmentioning
confidence: 99%