China to Reduce Regulations and Boost Pharmaceutical Shares of Traditional Medicine

The support for traditional medicine in China is extremely widespread, with even President Xi Jinping having called this type of medicine a “gem” of the country’s scientific heritage, and promising to give traditional therapies and Western medicine equal government support. Recently, the country began to take dramatic steps to promote these cures, even as researchers raise safety concerns about traditional treatments.

Starting in early 2018, 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 that traditional medicines can skip such costly and time-consuming trials, so 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 is set to compose a list of the approved methods.

The Chinese government has recently been strongly promoting traditional Chinese medicines as a cost-efficient alternative to pricey Western pharmaceuticals. Chinese medicine practitioners have expressed support for the new policy, with the general consensus being positive regarding the easier production process for companies who manufacture such medicines. Lixing Lao, director of Hong Kong University’s School of Chinese Medicine, has stated 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.

However, not everyone is pleased with these pending policy changes. Many Chinese scientists continue to say that safety concerns plague the industry, and that minimizing clinical-trial requirements is liable to put more patients at risk. On September 23rd, the CFDA recalled batches of two injectable TCMs after around ten people fell ill with flu-like symptoms.

On October 18th, researchers in Singapore and Taiwan published a study in Science Translational Medicine which links liver cancer to aristolochic acid, an ingredient widely used in traditional remedies. Lead author Steven Rozen, a cancer-genomics researcher at Duke-NUS Medical School in Singapore, is convinced that aristolochic acid is somehow tied in to the development of the cancer, but has said that it is difficult to determine to what extent it caused the tumors.

In addition to reducing regulations around Chinese traditional medicine, the Chinese government has made it easier than ever to become a doctor of traditional medicine and to open hospitals that use these alternative therapies. Since July 2017, students studying traditional medicine no longer need to pass the national medical exams based on Western medicine. Instead, traditional medicine students can attend apprenticeship training and pass a skills test. Practitioners who want to open a clinic also no longer need approval from the CFDA. They need only register with the local authority.

The ultimate goal of the Chinese government is to have all Chinese health-care institutions providing a basic level of traditional Chinese medicine by 2020. A statement released by the State Council, China’s highest administrative body, detailed plans to increase the number of traditional medicine-licensed doctors to 4 per 10,000 people, an increase from less than 3 practitioners per 10,000 people. The government also intends to boost the share of traditional medicine pharmaceutical sales from 26% to 30% by the end of the decade.