New Regulations Allow for Imports

The National Medical Products Administration (NMPA) has released a draft announcement for public consultation regarding pilot zones using imported bezoar for the production of traditional Chinese medicine (TCM). This move aims to address the domestic shortage of bezoar, a key ingredient in many TCM products.

Bezoar, also known as gallstones, is a rare substance formed in the gallbladder of cattle. It is widely used in TCM clinical practice, particularly in Angong Niuhuang Wan, a popular medication for treating febrile diseases, convulsions, strokes, and other conditions.

However, the supply of natural bezoar has been unable to meet the increasing demand, leading to a significant price increase. This is due to the scarcity of natural bezoar, rising demand from an aging population, and the increasing incidence of stroke.

Historically, China relied on imports for bezoar. However, following the global mad cow disease outbreak around 2000, the NMPA banned the use of imported cattle-derived materials in TCM production. This resulted in a complete halt of bezoar imports.

To address the ongoing shortage, the NMPA and the General Administration of Customs have partnered with relevant departments to study the feasibility of policy adjustments. The study included reviewing scientific data, current mad cow disease conditions, WHO Codex regulations, and measures for quarantine and risk control of imported bezoar.

Based on these studies, the draft proposal allows for the importation of bezoar from countries and regions free from mad cow disease. The imported bezoar must pass Chinese customs quarantine and port drug inspections to be used in TCM production.

The announcement specifies the requirements for the source countries, importing companies, customs procedures, application processes, and inspection units. During the two-year pilot period, bezoar from compliant regions that meets Chinese customs and quality standards will be permitted for use in TCM production. After the pilot period, the results will be evaluated, and the program may be expanded nationwide.

Industry insiders believe that allowing imports could significantly alleviate the domestic supply shortage of bezoar and substantially reduce the price of Angong Niuhuang Wan, benefiting many patients. They also emphasize the importance of establishing comprehensive traceability systems to ensure strict control, quarantine, and traceability throughout the entire process.