A New Record of the New Chinese Medicine Approval with the Review & Approval Systems Reform of the Traditional Chinese Medicine

The Chinese civilization has been in existence for over five thousand years, and the traditional Chinese medicine is one of the most crucial treasure, which embodies the vast wisdom of the Chinese people and the Chinese nation. During the long historical years of the Chinese nation, the 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 the 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 the Chinese medicine. 

Summary of Approved Varieties of Traditional Chinese Medicine in 2021 

Recently, the National Medical Products Administration approved the application for 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. 

In accordance with the announcement of the National Medical Products Administration, up to now in 2021, NMPA has approved 6 new drugs of traditional Chinese medicine on the basis of the emergency approval of Qingfei Paidu Granules, Huashi Baidu Granules and Xuanfei Baidu Granules. The year of 2021 is proved to be the year in which the most new drugs of the traditional Chinese medicine were approved in the past 5 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, and also a strategic industry with strong development advantages and broad market prospects in China's national economy and social development. At present, traditional Chinese medicinal materials, traditional Chinese medicine decoction pieces and Chinese patent medicine are the three pillar industries of China's traditional Chinese medicine industry with the quick development of TCM equipment. And today we will mainly concentrate on the development of the last one. Recently, Chinese medicine has got more and more public awareness, and the status of Chinese patent medicine in the national economic development has been enhanced. Taking the national basic medical insurance drugs as an example, the newly announced 2021 national basic medical insurance drugs catalogue contains 2,860 kinds of drugs, including 1,486 pharmaceutical chemicals and 1,374 Chinese patent medicine. The proportions of pharmaceutical chemicals and traditional Chinese medicines are basically 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 the traditional Chinese medicine. However, we have to admit that there is a certain lack of momentum for Chinese patent medicine in some areas in China, and the homogenization of products is clear. In addition, the products of domestic Chinese patent medicine enterprises are with low degree of innovation, low level of technology and imbalanced product structure. 

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.