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Licensing traditional Chinese medicines

For a long time, traditional herbal medicines were available throughout Europe without any proper quality control and regulation. Concerns about patient safety lead to the publication of the Traditional Herbal Medicinal and Herbal Products directive in 2004 which came into force in 2011. This means that no herbal remedy medicine can be legally sold throughout the EU unless it has a licence which means that the product has passed stringent safety quality checks and has been used safely for at least 30 years, 15 of which must have been in the EU for at least 15 years.

At Phynova, we welcome the new legislation and we were delighted when our own Chinese medical product Phynova Joint and Muscle Relief Tablets containing the active ingredient Sigesbeckia, was granted a Chinese traditional medicine licence by the Medicines and Healthcare Products Regulation Agency in 2015. It had been a long difficult process, not least because it was the first time that the MHRA had considered a Chinese traditional herbal medicine and they were understandably cautious. Fortunately, the founder of our company Phynova  Robert Miller has been importing many different Chinese herbal medicines for over 30 years into Europe so we were able to show evidence that this remedy had been used safely for an extended period of time.

It is the UK’s only licensed Chinese traditional herbal medicine to date and it is now being sold in high street retailers including Boots. The only other Chinese herbal remedies that can legally be sold in the UK are those made by practitioners with special licences who are making individual prescriptions but these are not sold over the counter.

Sigesbeckia grows wild in many parts of China but is not found here. Clinical trials show that it has an anti-inflammatory and pain-relieving effect for joint pain without causing any known side effects. The active ingredient in the plant acts on several aspects of the inflammatory response in the human body which inhibits the production of prostaglandins which are important parts of inflammatory response. We are now doing field trials in Cambridgeshire in the hope that we can grow our own Sigesbeckia from reliable feed stock so that the active ingredients can be precisely calibrated tightly controlled.

We are in the process of getting a licence for another traditional Chinese herbal remedy for colds and flu in collaboration with a Chinese company and we expect that there will be many more traditional Chinese herbal medicines that become available to UK consumers in the next few years.

Andrew Gallagher
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