A traditional herbal medicinal product manufactured in China has for the first time been given the go-ahead for sale in Europe, under the continent’s strict new laws to ensure the safety and quality of herbal products.
Around 350 herbal medicines so far are licensed for sale in Europe under the Traditional Herbal Medicinal Products Directive (THMPD), which came into force in April 2011, but they are all manufactured in Europe. (Nature explained the herbal-medicine rules in a recent outlook.)
Advocates of alternative medicines worried that the new rules, which cover manufacturing practices and biochemical analysis, would deter Asian manufactures from the European market and so limit the range of herbal medicines available to patients. The stricter rules aim to ensure a better understanding of the products’ active ingredients and weed out those containing potentially harmful or undesirable substances. (Nature reported last week on recent studies showing that many products contain ingredients derived from endangered animals and toxic plants.)
But the Chinese product now licensed for sale in the Netherlands, and used for the relief of headaches, pains and cramps, signals a step in the right direction.
“About time,” says the UK Alliance for Natural Health International, a campaign group promoting alternative approaches to health care, in response to the news. But in a statement on its website, the alliance says that manufacturers of Chinese herbal products and products from other Asian traditions still face an “up-hill struggle” to win THMPD licences.
The directive is “particularly unsuitable for multi-herb products of the type that make up the overwhelming majority of the non-western products,” the alliance says. Identifying active ingredients in products containing several herbs is difficult, time-consuming and expensive, and does not make good business sense for Asian manufactures.
It is “no surprise” that the newly approved Chinese product is a single-herb extract of rhizomes of Japanese yam, the alliance says.
The Dutch Medicines Evaluation Board (MEB) says that assessing the product, known as Diao Xin Xue Kang, was “not an easy task”. The board travelled to China to ensure that the manufacturing processes of Diao Chengdu Pharmaceuticals, which makes the product, are up to scratch.
The next big leap will be for an herbal medicinal product to reach the lofty status of a medical drug approved for use in the treatment and prevention of disease. This is probably still some way off.