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This study aims to summarize the research hotspots of Hedysari Radix and predict the research trend with bibliometric methods, which is expected to serve as a reference for future research. CiteSpace V 5.8.R2 was employed for visualization of the number, authors, author affiliations, journals, funds, and keywords of the Chinese and English articles on Hedysari Radix in China National Knowledge Infrastructure(CNKI) and Web of Science(WOS) from 2001 to 2021. A total of 693 Chinese articles and 167 English articles were finally included. According to the knowledge map, most of the articles were from China and the authors from China had a close cooperation with the related institutions in the United States and Australia. Gansu University of Chinese Medicine(288) and Lanzhou University(151) respectively came out on top of the author affiliations in the number of Chinese and English articles. The journals were mainly about Chinese medicine, mainly including Chinese Journal of Information on Traditional Chinese Medicine and Evidence-based Complementary and Alternative Medicine. Papers(191 in Chinese and 60 in English) funded by National Natural Science Foundation of China were the most. Keyword analysis suggested that the main research directions were pharmacological action and mechanism, component analysis, content determination, and industrialization of medicinal materials of Hedysari Radix and that the research hotspots were the prevention and treatment of diabetes and its complications, tumors, myocardial injury, liver fibrosis and other diseases with active components such as polysaccharides, ultrafiltrate, formononetin, and calycosin. The targets, signaling pathways, and genes related to the anti-tumor, heart protection, prevention and treatment of diabetes and its complications, and regulation of immunity should be further studied.

To analyze the development of coronavirus disease 2019(COVID-19), this study systematically retrieved relevant Chinese and English literatures from both CNKI and Web of Science database platforms by bibliometric research method and CiteSpace 5.5.R2 software to obtain information and visualize relevant literatures. A total of 695 Chinese and 446 English literatures were included in this paper. Statistics showed that China had published most of the literatures and established close cooperation with the United States and the United Kingdom. Through the analysis, Tongji Medical College of Huazhong University of Science and Technology and its affiliated hospitals published the largest number of the publications. Moreover, the highly productive journals including Journal of Traditional Chinese Medicine and The Lancet covered eight major fields, such as medicine, medical virology, radiation medicine, infectious disease, and traditional Chinese medicine. Besides, a total of 35 special COVID-19 funds were recently established to subsidize these studies. The key words and themes analysis indicated that protein structure of COVID-19, receptor targets and mechanisms of action, integration of traditional Chinese and Western medicine, screening and development of antiviral drugs from traditional Chinese medicine and Western medicine, vaccine research as well as epidemiological characteristics and prediction are current study hotspots. This study provides a reference for researchers to rapidly master main study directions of COVID-19 and screen out relevant literatures.

This paper comprehensively analyses the background and meaning of The Technological Guiding Principle for Assessment of Chinese Medicine Resources enacted by the former CFDA ( China Food and Drug Administration), moreover, it also points out that the Chinese medicine resources assessment with the purpose of guaranteeing the sustainable supplying capacity of Chinese medicine resources is the premise of new drug development; the Chinese medicine resources assessment which takes quality guarantee as the core is a significant action to promote the fixing of place of origin and quality-management antedisplacement for the traditional Chinese medicine industry; in this regard, the Chinese medicine resources assessment which aims at realizing the whole-process traceability is the key to building the high-quality modern traditional Chinese medicine brand. The Chinese medicine resources assessment which takes the classical prescription as the entry point is the embodiment of the protection of traditional Chinese medicine resources and international vision of regulation, which aims at clarifying the thinking for the relevant enterprises to carry out the Chinese medicine resources assessment. Base on the general thinking of ensuring that the "total amount of Chinese medicine resources is fixed and the supply is guaranteed", this paper clarifies two methods of Chinese medicine resources assessment: "family property assessment" of Chinese medicine resources based on "fixed total amount", "supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee". In this regard, the basic strategy of "supply and demand balance assessment" of Chinese medicine resources based on "guaranteed supply" is put forward and it is believed that the resources assessment will lead to the significant adjustment of traditional Chinese medicinal materials production. It becomes the only way for the development of various Chinese medicine production enterprises to realize the comprehensive improvement of Chinese medicine quality, brand construction, the establishment of preferential price mechanism., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

The United States Patent and Trademark Office(USPTO) issued Interim Guidance on Patent Subject Matter Eligibility on December 16， 2014， bringing certain effects to the review rules on patent application of Chinese medicine compositions. Based on the Interim Guidance， cases analysis was used in this paper to analyze the patent subject matter issues of traditional Chinese medicine compositions in the United States. The researches have shown that the application documents should be properly written in the United States when the patent for Chinese medicine compositions is applied， which can improve the probability of authorization., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.