Warning of toxic medicinal materials in traditional Chinese medicine decoction pieces

China Food and Drug Administration issued the Notice on Revising the Quality Standard of Chinese Patent Medicines Containing Toxic Chinese Herbal Pieces (hereinafter referred to as the Notice). According to this document, before the end of 20 13, Chinese herbal medicine companies whose products contain toxic medicinal materials must specify the toxic components in the instructions and add warnings.

The notice requires that where the prescription contains Chinese patent medicines (including toxic processed products) made of 28 toxic medicinal materials recorded in the Measures for the Administration of Toxic Drugs for Medical Use (the State Council Order No.23), the relevant pharmaceutical manufacturers should indicate the names of toxic Chinese herbal pieces under the components in their instructions, and add the warning words "This product contains ××" in the corresponding position.

The Notice clearly states that the prescription contains other varieties of Chinese patent medicines that have been proved to be toxic and easy to cause serious adverse reactions, and relevant pharmaceutical manufacturers should also revise the instructions according to the above requirements. It is worth noting that this new regulation also applies to varieties of Chinese patent medicines involving state secret technology.