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

"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 recognized 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. According to Liu, the advantage 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 registration.

"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.

The increasing number of TCM doctors who are practicing and recommending TCM treatments has increased its reputation in British society, Mei said.

"The effectiveness of TCM is now gradually becoming accepted by officials, health authorities and some members of parliament," he said.

Over the past five years, Mei and other representatives of TCM practitioners in the UK have been lobbying health authorities to adopt regulations acknowledging TCM as a bona fide treatment even if it is not given the same status as mainstream modern medicine.

"So far, it has been listed on the legislative agenda of the GMC (General Medical Council) of the United Kingdom, and it could be possible that in two years, there will be a draft law submitted to parliament," Mei said.

When Brian Tai-shen Wang opened his first TCM store in a shopping area in central London in 1984, he was embarrassed to find drug users among his customers.

"Ours was the first TCM store outside the Chinese community in London, and local residents were wondering what kind of herbs we were selling," said Wang, president of UK-based Herbal Inn, a TCM chain store. "Consequentially, some drug users would come in and ask for marijuana," Wang said.

After almost 20 years of struggle, Wang's chain has now grown to 40 stores, spanning the United Kingdom. "All of them are outside the Chinese communities," Wang said at his store in Oxford Street, London's shopping center.

Wang is not alone. Now TCM stores have mushroomed all over the UK, totaling about 3,000, according to the Embassy of China in London.

Wang is not trained as a TCM doctor, but learned about it as a hobby. He came to the United Kingdom from Taiwan Province in the early 1970s, and worked as a government adviser of ethnical issues. In his spare time, Wang taught his foreign colleagues Tai Chi Chuan, or shadowboxing.

"I found that their interest in Tai Chi was very strong and I should introduce more Chinese culture to them, which could also become a business opportunity for me," Wang said.

At the time, TCM stores existed, but Western people were unfamiliar with the practice. "Some of them even looked upon TCM as witchcraft," Wang said.

After US President Richard Nixon's first visit to China in 1972, however, the public's interest in acupuncture, a part of TCM, began to escalate in the West.

Traveling with Nixon was a New York Times reporter James Reston, who received acupuncture in China after undergoing an emergency appendectomy. He was so impressed with the procedure's ability to relieve his post-operative pain that he wrote about his experience on returning to the US.

With Reston's introduction, acupuncture entered Western medicine as a supplement, but most people did not know it derived from TCM.

Wang sensed an opportunity. In the early 1980s, he left his position as a government adviser and opened an acupuncture store in London, linking acupuncture to TCM.

"I could have operated such a store in the Chinese communities, but it would never have entered mainstream society and would certainly have had a limited impact," Wang said.

Susanna Shu Jiang joined Wang's business in the mid-1980s and this quickened the development of Wang's store. Now Jiang is Wang's partner.

Jiang was trained as an acupuncturist in Shanghai. In the early 1980s, she came to London to study English. Jiang helped Wang enroll more professional TCM doctors and import high-quality herbal drugs from the Chinese mainland. The store quickly gained a good reputation among patients, especially those suffering from chronic diseases.

"We are not allowed to advertise but this does not impede our business development. Rather, we always stress our TCM is a diet supplement and has low safety concerns," Wang said.

This idea was easier for Westerners to accept, especially with more people becoming vegetarians in the West.

Wang and Jiang adapted their stores to the vegetarian market and purged their shelves of any TCM items that contained animal products.

"In original TCM, animal elements are an important part, but here, only pure herbal products are more attractive to local residents. In addition, animal products are more likely to be subject to strict government control," Wang said.

But even with the abandonment of animal products, regulatory challenges still exist. In many cases, UK medical authorities often find excessive lead content in heshouwu (Ploygoni Multiflori), and most recently, high mercury in aloe.

"Although we have repeatedly explained to them that in the long history of TCM, the toxicity could be balanced by adding other materials, they do not accept it easily," Wang said.

Wang and Jiang abide by the UK rules, and have actively sought alternatives. They also explain disease symptoms in a language that Western patients understand.

"We do not talk about yin and yang (negative and positive energies in the human body), or the five internal organs in the TCM tradition, which is quite different from modern medicine," said Jiang.

(China Daily January 12, 2007)