A proposal for Scheduling of Chinese Herbal Medicines in China

中囯中药分类管理的建议方案


by Dr George Li
CSC academic group: Traditional Chinese Medicines

Dr George Li is the Sesquicentenary Lecturer in Herbal Medicines Faculty of Pharmacy and China Studies Centre. He received his PhD from Sun Yat-sen University in 1988. He was the Coordinator of the Herbal Medicines Research and Education Centre and Master of Herbal Medicines during 1997 - 2011. His research focuses on the quality control, chemistry, pharmacology and toxicology of botanical medicines.

quote Although Chinese medicine is based on a long history of culture and clinical practice, the safety of Chinese herbal medicines in a Western context has been a major concern.

In July 2012, Australia became the first Western country to register Chinese medicine practitioners in the Register of Practitioners run by the Australian Health Practitioner Regulation Agency. Although Chinese medicine is based on a long history of culture and clinical practice, the safety of Chinese herbal medicines in a Western context has been a major concern. The China Studies Centre project aims to answer these concerns by evaluating the evidence of potentially toxic Chinese herbs. The international research team led by Dr George Li involves the Faculty of Pharmacy, Sydney Medical School, School of Information Technology of the University of Sydney, Sun Yat-sen University and the Beijing University of Chinese Medicine.

The team has identified issues in criteria and classification inconsistencies in the Australian and Chinese government regulations on potentially toxic Chinese herbs. A new toxicity ranking criteria has been proposed to include risk-benefit analysis, severity of toxic effects, clinical and preclinical data. A regulatory platform of potentially toxic herbs and a prototype online database has been developed. The proposal has been published in the Journal of Ethnopharmacology (Kim et al., 2013).

Some members of the international research team

Some members of the international research team

Regulations in China

Chinese medicine and pharmaceuticals are regulated in China by the Medicine Act of the People’s Republic of China (28 Feb, 2001). Article 37 specifies a national regulatory management system of prescription and non-prescription medicines. Specific regulations are issued by the State Council . It appears, however, that the actual implementation of the regulation of prescription and non-prescription medicines has not been fully completed.

A national regulation, Medicinal Toxic Drugs Control Regulations, has set procedures for the prescription of extremely toxic drugs and 16 raw herbs such as raw aconite (The State Council of the People's Republic of China, 1988). A similar list of toxic Chinese medicinal materials has been issued in the Hong Kong Chinese Medicine Ordinance Schedule 1 (The Hong Kong Government, 1999). The toxicity ranking of Chinese medicines is also set in the Chinese Pharmacopoeia. However, the toxicity ranking criteria are not well defined (Chinese Pharmacopoeia Commission, 2010).

The proposal for revision of scheduling of Chinese herbs

We have identified seventy-four Chinese herbal medicines which are potentially toxic. Many differences between Chinese and Australian regulations were found and five of them were selected for detailed study. The evaluation criteria were set as risk-benefit analysis, severity of toxic effects and clinical and preclinical data. We have proposed a platform of four regulatory classes:

1. Prohibited for medicinal usage, which are those with high toxicity and can lead to injury or death, e.g. aristolochia.
2. Restricted for medicinal usage, e.g. aconite, asarum and ephedra.
3. Required warning label, e.g. coltsfoot.
4. Available over-the-counter for those herbs with a safe toxicity profile.

quote We believe the new platform will ensure their safe use and satisfy the need for access to the herbs.

We believe the new platform will ensure their safe use and satisfy the need for access to the herbs. The current Chinese and Australian regulation of Chinese herbal medicines should be updated to restrict the access and use of some potentially toxic herbs to Chinese medicine practitioners whose qualifications are recognized through the qualification system.

Homepage of the Toxic Chinese Herbal Medicines Database, a prototype

Homepage of the Toxic Chinese Herbal Medicines Database, a prototype

The success of the CSC funding

The project has imparted solid research training to two honours students Ellie J Y Kim and Johnson Q Huang, through critical analysis, report writing and presentation at conferences. The project has provided Yuling Chen with a solid postdoctoral training in regulation of Chinese medicine and essential skills in project managements. The project has played a critical role in developing international collaboration of TCM for researchers from Guangzhou and Beijing.