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Strengthening the regulation of herbal medicines in Europe

Although widely used, the efficacy of many herbal drugs is unproven. Moreover, many consumers misinterpret the natural origin of herbal medicines as a sign of safety, without appreciating that herbal ingredients can cause serious adverse effects. One of the worst cases of herbal misuse in Europe occurred in 1998, when over 100 Belgian women developed kidney failure after taking slimming pills containing the herb Aristolochic fangchi. 18 of them went on to develop urothelial carcinoma. Each year in the UK, the Medicines and Healthcare Products Regulatory Agency receives about 70 suspected adverse drug reaction reports relating to herbal medicines.
To protect consumers, the European Parliament and Council adopted the Traditional Herbal Medicinal Products Directive, 2004/24/EC on March 31, 2004. The Directive requires all herbal medicinal products to meet standards of quality, safety, and efficacy before they can be registered and marketed in the European Union (EU). For those products marketed before the legislation, the Directive gave a 7-year transitional period to register them before April 30, 2011. Up to March 23, 2011, the MHRA had received 211 applications, 101 of which have been granted a Traditional Herbal Medicinal Registration licence.
The herbal medicines industry will be seriously affected by the Directive, especially in China, from where no manufacturer has successfully registered their herbal medicinal products in the EU. Hence, all herbal medicinal products from China will be banned in the EU from May 1, 2011. The Directive will also affect patients and herbal practitioners. Patients who use herbal remedies will not have access to treatments if the products have not been authorised, which might encourage them to purchase the products from alternative, less well-regulated sources. Herbal practitioners will find their legitimate pharmacopoeia limited. Nevertheless, the Directive is a vital step to safeguard public health in the EU. The public has a right to expect that licensed medicinal products, whether herbal or not, are safe and effective. Other countries, where herbal regimens are popular, have a similar obligation to implement standards of quality, consistency, and evidence for their own citizens.



Source:  The Lancet



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