BEIJING, Jan. 12 -- Traditional Chinese medicine (TCM) has taken one step closer to becoming recognised in the United States and Europe, according to a top TCM researcher.

TCM manufacturers are conducting clinical trials in the US and have also established joint research facilities. Photo Gallery >>>

     "This is a result of mutual understanding and adaptation between Western pharmaceutical regulators and Chinese TCM manufacturers," said Ye Zuguang, director of the National Engineering Center for TCM Compounds.

    He was speaking at a seminar at the end of last month marking the completion of his research center, jointly established by the China Academy of TCM (CATCM) and a leading TCM manufacturer, the Tongrentang Group.

    Ye told China Daily that the easing of regulations on herbal medicine in the United States and the European Union (EU) has led Chinese TCM manufacturers to conduct several clinical trials of their drugs in the US and to prepare for registration in the European Agency for the Evaluation of Medicinal Products (EMEA).

    "If everything goes smoothly, TCM will become recognised drugs in the US and EU markets in about three years," Ye said.

    At present TCM can only be taken as a nutritional supplement if proved safe.

    In 2003, the US Food and Drug Administration agreed herbal medicines that have long been used, can be registered as drugs even without clear chemical compounds, as long as they can be backed by good clinical trial data and quality stability.

    In 2004, the EU passed a law stipulating that by 2011, herbal products sold in Europe can be registered as drugs based on their safe records over a 15-year period.

    With the easing of laws in the US at least two TCM manufacturers, Tianjin and Zhejiang producing drugs for heart diseases and cancer respectively have entered the second stage of clinical trails in the US.

    "Not requiring clear chemical compounds is a major concession by the Western drug regulators in their attitude towards TCM.

    "Chinese TCM manufacturers and researchers should now quicken their adoption of international rules, especially for quality control and clinical trails," Ye said.

    Liu Baoyan, vice-president of CATCM, agreed with Ye.

The UK has the biggest TCM presence in Europe. In London alone, there are about 700 stores. Photo Gallery >>>

    According to Liu, the advantages of TCM is that it can target a variety of diseases with a complexity of ingredients, instead of a single active molecule like that in Western modern medicine.

    "Making traditional Chinese medicine for worldwide use does not mean extracting single molecules for all TCM prescriptions, which is impossible and unnecessary.

    "But by manufacturing it for worldwide use, it takes a modern and scientific approach to stabilizing its quality and curative effects," Liu said.

    His academy has formed a strategic alliance with the National Center for Complementary and Alternative Medicine (NCCAM), a component of the US National Institutes of Health (NIH) to support joint TCM research.

    Man-Fang Mei, chairman of the UK-based Mei's Group and the AcuMedic Foundation, is confident his long struggle will lead to a specialized law regulating TCM in the United Kingdom in the near future.

    If passed, it would be the first law on TCM in the West.

    "Since the United Kingdom has the biggest TCM presence in Europe, this law will certainly improve its status in the West," Mei told China Daily.

    Mei believes the law is necessary, because TCM's popularity is rapidly growing in the United Kingdom. In London alone, there are at least 700 TCM stores.

    Because it does not have official status in the UK, TCM cannot be covered by medical insurance, and most importantly, it cannot be effectively regulated as a medical business. This has lead to some irregular or even illegal practices. Such practices are often destructive to TCM's reputation, which Mei and others have worked to improve for years.

    According to Mei, the legislative effort is also necessary because of the 2004 EU regulation requiring a period safety before registeration.

    "If we deal with it well, the EU rule could become a green light for TCM remedies to be recognized as medical drugs. If not, this could challenge the basic existence of TCM in Europe," Mei said.

    As one of the pioneers to introduce TCM to the UK, Mei has been actively advocating the official recognition of TCM. In the early 1990s, Mei and Beijing University of Chinese Medicines established the Chinese Medical Institute in London.

    He has been encouraging registered UK doctors and medical students to take the institute's courses.