Country's cold remedy enters the UK market
Updated: 2015-07-06 07:40
By ZHANG CHUNYAN(China Daily)
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The active ingredient in the tablets is a plant called Siegesbeckia orientalis, which is prepared by Purapharm Pharmaceutical Co in Nanning, capital of China's Guangxi Zhuang autonomous region, and shipped to Surapharm Services Ltd in the UK for manufacture.
Phynova, founded in 2002, specializes in developing new medicines and registering them with the authorities. The company employs 10 scientists in the UK and six in China.
Its operation in China grew after it invested in Botanic Century Co, a life sciences company in Beijing, in 2006.
Xiangxue specializes in the development and modernization of TCM products and is the first company to establish a TCM research and development center outside of China, opening a base in Cambridge. Thanks to its collaboration with Phynova, it is also the first Chinese pharmaceutical company to have access to Europe's lucrative over-the-counter market.
"As a Chinese company, it is really essential for us to have a European partner to in-crease our chance to succeed in what is a very demanding market," Wang said.
Miller added: "We've established good cooperative relations over the past several years, and we'll work together in the future to bring more safe and effective TCM products to Western markets."
The application of Isatis Cold and Flu Relief sends a healthy message for comp-anies making TCM products, yet industry expert Robert Verkerk warns that obstacles may stand in the way of similar applications in the future.
"It is a positive development that products related to TCM can be made more widely available to the EU market," said the executive director of the Alliance for Natural Health International, a UK-based international NGO that promotes natural and sustainable approaches to healthcare.
"However, this new application for Isatis is for a single herb, like its predecessor the Sigesbeckia-based product for joint and muscle relief," Verkerk added.
Single herb products are by and large considerably easier and cheaper to register and are not the typical multi-component formulas associated with TCM."
As Miller explains, there are technical difficulties involved with manufacturing TCM to the EU Good Manufacturing Practice standards as well as many other points to consider, such as passing the toxicological assessment.
"For a product to be approved, the applicant has to demonstrate evidence of use of the main ingredient over the past 30 years, including 15 in the EU," he said.
Unlike Western medicines, which normally contain a single chemical compound, TCM have on average 20 ingredients, and each ingredient may contain several compounds.
"(However,) from our experience, the MHRA has been helpful in guiding us through the application process," Miller added. "By working with the UK authority, we will continue to register more TCM products."
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