China launches traditional medicine safety research
The Chinese government has launched a new programme to fund research into the safety of traditional Chinese medicines.
The government declined to specify the exact budget for the programme, which was announced last week (19 October) and will run for the next five to ten years.
The programme aims to address 8-10 urgent technical problems that relate to seven areas of safety control in medicine. These include upgrading drug safety standards, improving pre-clinical safety assessments, improving safe drug production, and strengthening the supervision and alarm systems for traditional Chinese medicine (TCM).
The programme is backed by the Ministry of Science and Technology, the State Food and Drug Administration and the State Administration of TCM.
"We will complete a set of medicine safety technology standards within five years, covering 10 to 20 treatments used in TCM," said Wang Hongguang, director general of the China National Centre for Biotechnology Development.
A key focus is the toxicity of TCM injections, because they are complicated — composed of dozens of or even hundreds of different herbs — making it difficult to identify the source of any adverse reaction.
Most TCM injections are used to treat cardiovascular disease and inflammation.
A decade-long survey by Ye Zuguang, a professor at the China Academy of Chinese Medical Sciences in Beijing shows that more than 70 per cent of the negative responses to TCM arise from injections. "About 80 per cent of these responses are allergic reactions," he said.
The new research programme aims to discover which substances cause negative responses — such as redness of the skin and shortness of breath — as a result of TCM injections.
One potential research topic will be to find an efficient methodology to help identify which substances caused the reactions.
Qian Zhongzhi of the China Pharmacopoeia Committee, part of the State Food and Drug Administration added that it could be easier to devise a quick method to identify whether someone will have an allergic response before they are given an injection, for example by testing the substance on a small area of skin.
In addition, the programme will help establish general drug quality control standards for laboratories for pre-clinical tests.
A spokesperson for the Ministry of Science and Technology said funding applications would open next month. Foreign researchers or institutes can participate as joint partners in the research, which is expected to begin by the end of the year.
The problem of drug safety has been highlighted by a number of deaths over the last two years.
In July, an antibiotic injection called Xinfu led to the deaths of six people in China. And in the same month, China revoked the licence of another drug company, Qiqihar No. 2 Pharmaceutical Co Ltd, which had produced a drug for gastric disorders that killed 11 people.Between 2000-2005 China spent one billion yuan (US$12.6 million) in creating new medicines and modernising traditional Chinese medicines.