Two students are checking a bag of traditional Chinese medicine in a store. [Photo/IC]

An application to sell awell-known Chinese cold and flu remedy in the United Kingdom has sent a positive signal for manufacturers of traditional Chinese medicine, or TCM, looking to enter the lucrative European markets.

The UK Medicines and Healthcare Products Regulatory Agency received a request to approve Isatis Cold and Flu Relief, based on the Chinese product Ban Lan Gen, in June.

Phynova, a life sciences company based in Oxford, submitted the application in collaboration with Xiangxue Pharmaceuticals Co Ltd, a leader in the modernization of TCM.

"It is a safe and effective product for cold and flu, and we think it'll be welcomed in the UK when the product is approved," said Robert Miller, CEO of Phynova Group Ltd.

Ban Lan Gen, which is derived from the root of a flowering plant called woad, or Isatis tinctoria, has been a popular flu remedy in China for many years. In 2003, it made headlines when people began using it en masse during the SARS epidemic, and again several years later during outbreaks of swine flu and avian flu.

"For application, we've worked closely with Phynova to ensure the product satisfies the European Union's Good Manufacturing Practice requirements, and that the materials were in line with regulatory requirements," said Wang Yonghui, chairman of Xiangxue.

"Phynova is committed to the development and commercialization of herbal products and TCM. Xiangxue looks forward to further collaboration to introduce more safe and effective TCM into the EU market."

The MHRA, which could make its decision in 210 days, is responsible for ensuring the safety of medicines and medical devices on sale in the UK. The agency drafted the EU Traditional Herbal Medicinal Product Directive, released in 2004 to protect consumers and ensure treatments meet high standards. This led to many TCM products no longer being available over the counter in Europe.

However, the market is massive. In the UK alone, consumers each year spend almost 400 million pounds ($630 million) on cold and flu remedies, and industry insiders said the demand for natural remedies is stronger now than ever.

TCM, which has evolved over 4,000 years, relies largely on patented and herbal medications to prevent illness and help fight ailments, as well as relieve pain and restore balance－the ying and the yang－to the body.

Prior to its latest application, Phynova obtained the first MHRA approval for a TCM product to be sold over the counter in Britain.

"Since that product－Phynova Joint and Muscle Relief Tablets－was approved in February, we have increased in confidence toward the TCM product registration process," Miller said.