Traditional medicine enters UK market

The first traditional Chinese medicine to obtain market approval from the United Kingdom's Medicines and Healthcare Products Regulatory Agency can now be sold over the counter in the country.

The medicine, Phynova Joint and Muscle Relief Tablets, was developed by Phynova Group, a life sciences company in Oxford, England. An announcement outlining the MHRA's approval was made on Monday at the GREAT Festival of Creativity in Shanghai.

The move marks a significant development in the MHRA policy. It is the first time that the European Union's Traditional Herbal Medicinal Product Directive, introduced in April 2004, has successfully been used to register a TCM product in the UK.

The EU directive, which was designed to protect consumers and guarantee that the treatment is safe and meets high standards, has resulted in many Chinese medicines that are popular in European countries no longer being available over the counter without a prescription.

Robert Miller, chief executive officer of Phynova, said that the approval process took around three years, but he expects the period to be shorter for other medicines the team will put forward for approval in the future.

The active ingredient in the tablets is a plant called siegesbeckia orientalis, which is prepared in Nanning, capital of the Guangxi Zhuang autonomous region, by a Chinese company called Purapharm Pharmaceutical Co, and the finished product is manufactured in the UK by a company called Surapharm Services Ltd.

Phynova, which was founded in 2002, now employs 10 scientists in the UK. Its China operation grew as a result of investing in a life sciences company in Beijing called Botanic Century Co since 2006, and its China team includes six scientists.

The company specializes in developing new medicines and registering them with the relevant authorities. Miller said since the MHRA granted approval for the tablets, a number of pharmaceutical companies have approached him to explore the opportunity of selling the treatment under their own brands.

Phynova is in the process of applying for regulatory approval for several other TCMs, including Isatis, a cold cure manufactured by a Chinese company called Xiangxue Pharmaceuticals Co.

Isatis traditionally comes as a brown powder that is mixed with water, and Phynova has been working to develop a Westernized form of the medicine by adding lemon and honey to the ingredients to suit the Western palate. An application for Isatis will be submitted in April.

Miller said the EU directive provides great protection for consumers, and that the HMRA approval process has been fair in its assessment of TCM. He foresees great opportunities for his team to help gain approval for a wide range of TCM because it has the expertise to translate TCM theory into terms Western scientists will understand.

For example, if a plant extract in TCM is known to dissipate heat for lower temperatures, it can be matched with scientific Western terms such as antiviral, antibacterial or anti-inflammatory.

"It's possible to prove that almost any traditional Chinese medicine can pass any tests conducted by Western science, and that's the only way that TCMs will ever be fully accepted in Western markets," he said.