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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.)