The Chinese government is working to resolve quality and efficacy issues surrounding raw and finished Traditional Chinese Medicine products with the help of partners in the United States. The government has drafted new quality initiatives designed to improve the reception of TCM products in the global marketplace and in the United States in particular.
The State Drug Administration, China's equivalent to the U.S. Food and Drug Administration, has been working with industry liaison Loretta Zapp since 1997 to not only bring quality programs in China to fruition but also to educate the American marketplace that such programs exist. In 1996, Zapp founded the Institute for Nutraceutical Advancement, which developed analytical standards for botanical raw materials in the United States. One of the programs currently in development is Beijing United Analytical Labs, a quasi-governmental Chinese laboratory certification program. It is envisioned that this program will work closely with laboratory testing programs in the United States. SDA also has mandated revised Good Manufacturing Practices and Good Agricultural Practices for all TCM products manufacturers in China.
China's programs are intended to provide authoritative scientific data to buttress the traditional cultural knowledge that has supported TCM for centuries, according to Zapp. "Advanced analytical methods, including chemical and DNA fingerprinting and optical biochip technology as well as clinical data from animal and human trials, will be utilized for proof of efficacy as well as safety," she said.
Professor Ren De Quan, SDA deputy director general, is the official liaison to the U.S. market for TCM products. He recently invited Zapp, industry consultant Rick Prill and Susan Haeger, New Hope Natural Media's director of global brand development, to China to visit GAP- and GMP-certified facilities, interact with TCM manufacturers in several cities and review the new regulations. Zapp and Haeger had the opportunity to relate some of the concerns and issues of the American market regarding sales and importation of TCM raw materials and products. The group also visited Tsinghua University in Beijing to witness ongoing clinical and scientific research programs related to TCM.
Natural Foods Merchandiser volume XXIII/number 10/p. 7