On October 21, Director General of General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) published No. 169 Z.G. Decree to disclose the Measures on Administration of Entry-Exit Inspection, Quarantine and Supervision on Traditional Chinese Medicine (hereinafter referred to as “Measure”), which will be applicable since 1 December 2015. As stipulated in the Measure for entry and exit of traditional Chinese medicine, companies should report their expected use while specifying its use as food or medicine.

The safety standard is quite different from the previous one. Warnings, returns and notifications are frequently met during export of traditional Chinese medicine due to quality issues, such as excessive heavy metals (mercury and lead), food additives (sulfur dioxide), residue of pesticides and biological toxicity.

However, the issuing of the Measure sets forth supervision requirements and principal responsibility for enterprises, especially the establishment of complete biological safety prevention system in countries or regions according to trading purposes. It is of vital importance to guarantee the sound development of the entry and exit of traditional Chinese medicine.

AQSIQ adopts reporting system for the use of traditional Chinese medicine intended for exit and entry as stipulated in the Measure. Companies should report their expected use to the Inspection and Quarantine Department specifying “food” or “medicine”. If specified with “food”, traditional Chinese medicine should be listed in medicine catalogue of Pharmacopeia of the People’s Republic of China; if specified with the latter, they are edible articles as per the stipulations of national laws, administrative regulations, rules and documents in China.

In light of principal responsibility of entry-exit companies, the Measure requires companies should conduct production, processing and operation in line with laws, administrative regulations and standards, shouldering the principal responsibility of epidemic prevention for the society and the public so as to guarantee the quality safety.

As we know, traditional Chinese medicine always requires no further processing, which leads to higher risk of the presence of hazardous creatures. The rapid development of trading volume for import and export of traditional Chinese medicine gives rise to the safety issues. The fact shows a rising detection level of traditional Chinese medicine carrying soil, weeds and pests in recent two years. So the Measure strengthens and standardizes the inspection and supervision on its entry and exit.