A New Record of the Innovative TCM Approval with the Reform of China’s Review and Approval Systems

The Chinese civilization has been in existence for over five thousand years, and traditional Chinese medicine is one of the most magnificent treasures, which embodies the vast wisdom of the Chinese people and the Chinese nation. During the long times of Chinese history, traditional Chinese medicine has played and has always played an irreplaceable historical role. From the Yellow Emperor's Inner Canon to the Compendium of Materia Medica, from Cow-bezoar Bolus for Resurrection to artemisinin, the traditional Chinese medicine has made indelible and outstanding contributions. Especially since the outbreak of the COVID-19, the participation breadth and depth of traditional Chinese medicine in the fight against the pandemic have been unprecedented, and the results achieved are remarkable, which also fully confirms the peculiar curative effect of Chinese medicine. 

Summary of Approved Varieties of Traditional Chinese Medicine in 2021

Recently, the National Medical Products Administration approved the application of the registration of three traditional Chinese medicine innovative drugs, namely Xuanqi Jiangu Tablets, Qizhi Yishen Capsules, and Kunxinning Granules. In addition, another innovative drug of traditional Chinese medicine, Yinqiao Qingre Tablets, was also approved for marketing in November.

According to the announcement of the Chinese National Medical Products Administration, up to now in 2021, NMPA has approved six new drugs of traditional Chinese medicine based on the emergency approval of Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules. The year 2021 is proved to be the year of the most TCM new drugs approved in the past five years. (See Table 1 for details)

Table 1 Innovative Drugs of the Traditional Chinese Medicine Approved by NMPA in 2021

The traditional Chinese medicine industry is an essential part of China's pharmaceutical industry, with strategic advantages and broad market prospects in China's national economy and social development. Currently, Raw Material For Traditional Chinese Medicine, traditional Chinese medicine decoction pieces, and Chinese patent medicine are the three pillar industries of China's traditional Chinese medicine industry. Recently, Chinese medicine has got more and more public awareness, and the status of Chinese patent medicine in the national economic development has enhanced. Taking the nation's basic medical insurance drugs as an example, the newly announced 2021 national basic medical insurance drugs catalog contains 2,860 kinds of drugs, including 1,486 chemicals and 1,374 Chinese patent medicine. The proportions of pharmaceutical chemicals and traditional Chinese medicines are the same.

In addition, the traditional Chinese medicine industry has made great progress driven by such factors as the encouragement of national policy, market demand, and modernization of traditional Chinese medicine. However, we have to admit that there is a certain lack of momentum for the development of Chinese patent medicine in some areas in China, and the homogenization of products is clear. In addition, the products from Chinese patent medicine enterprises are in a low degree of innovation, low level of technology, and imbalanced product structure.