China’s State FDA Enforces New Rules For Traditional Chinese Medicine Registration

SHANGHAI - China's State FDA introduced new supplementary requirements for registering traditional Chinese medicine Jan. 8, to separate the process from western drug registration.

Under the new requirements, manufacturers will need to clearly indicate original ingredients, manufacturing sites and process parameters of TCM products.

"The provisions for drug registration do not fully reflect the characteristics of traditional Chinese medicine," Zhang Wei, director of SFDA's Drug Registration Division, told reporters at a monthly press conference in Beijing Jan. 10. "The Chinese medicine industry has also appealed repeatedly to establish a regulation embodying the characteristics of TCM."

The new requirements will also accommodate two new categories: "compound preparation from ancient classic TCM prescription" and "compound preparation for treatment of diseases indicated by TCM syndrome," according to Zhang.

Under the new requirements, a TCM product under the first category, which has demonstrated efficacy over long-term clinical application, will no longer require animal and clinical studies to prove its effectiveness.

Drugs under the latter category will require pharmacodynamic evaluation.

"The manufacturers will have to specify the source of prescription and the main functions of the product's specifications," said Zhang. "A specific catalog of TCM compounds, which can be defined under these two categories, will be developed and issued by SFDA and other relevant departments."

The new supplementary requirements will set forth higher standards for Chinese medicine formulations used in generic varieties.

According to Zhang, the new requirements will encourage enterprises to pursue new chemical entities research and development, while also supporting the development of TCM and the medicine of Chinese minority communities, including the Tibetan, Uigur and Mongolian communities.

"Many TCMs are time-tested, safe and effective," Paul Li, a San Francisco-based lawyer at Squire, Sanders & Dempsey LLP, told PharmAsia News. "While they may not be defined as drugs under the regulatory schemes of Western medicine, TCMs do meet the ultimate test of safety and effectiveness."

"The new rules provide an avenue for TCM products to be registered as drugs," added Li.

Li noted that TCM research and development is mostly conducted in Japan, Korea, Taiwan, China, Singapore and Hong Kong. However, Japan and Korea are ahead of China in terms of TCM R&D and modernization, according to Li.

"A major agenda in these new rules is to re-establish China as the rule-setting authority in TCM and retake the leading role in TCM R&D," said Li. "China certainly has the ability to do so, given its rich history of TCM research and application."

In the future, the TCM industry in China will be "more or less" regulated, Li predicted.

"The industry in China as a whole will gain a new momentum," said Li.

- Ying Huang ([email protected])