China to roll back regulations for traditional medicine despite safety concerns

Scientists fear plans to abandon clinical trials of centuries-old remedies will put people at risk.

• David Cyranoski

29 November 2017

Support for traditional medicine in China goes right to the top. President Xi Jinping has called this type of medicine a “gem” of the country’s scientific heritage and promised to give alternative therapies and Western drugs equal government support. Now the country is taking dramatic steps to promote these cures even as researchers raise concerns about such treatments.

From early next year, traditional Chinese medicines may no longer be required to pass safety and efficacy trials in humans in China. Draft regulations announced in October by the China Food and Drug Administration (CFDA) mean traditional medicines can skip such costly and time-consuming trials as long as manufacturers prepare ingredients using essentially the same method as in classic Chinese formulations. The State Administration of Traditional Chinese Medicine and the CFDA will compose a list of the approved methods.

The Chinese government has been forcefully promoting traditional Chinese medicines (TCMs) as an alternative to expensive Western drugs. Doctors of Chinese medicine have welcomed the new policy, saying that it will make it easier for companies who produce such medicines to get drugs approved and make them available to patients. Lixing Lao, director of Hong Kong University’s School of Chinese Medicine, says that although traditional medicines will no longer need to go through clinical trials, the CFDA will still require remedies to undergo preclinical pharmacological testing and drug-toxicity studies in animals or cells to gain approval.

Source: https://www.nature.com/news/china-to-roll-back-regulations-for-traditional-medicine-despite-safety-concerns-1.23038

China to roll back regulations for traditional medicine despite safety concerns