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China Journal of Chinese Materia Medica ; (24): 2845-2849, 2018.
Artigo em Chinês | WPRIM | ID: wpr-687376

RESUMO

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.

2.
China Journal of Chinese Materia Medica ; (24): 3223-3227, 2018.
Artigo em Chinês | WPRIM | ID: wpr-690392

RESUMO

At the end of 2017, the former China Food and Drug Administration promulgated " the Guiding Principles for the Assessment of Chinese Medicine Resources" whose purpose is establishing the concept of " the production of Chinese traditional medicines, herbal pieces and etc. should be based on the premise of ensuring the production and quality of Chinese medicine resources" for a licensed holder of a drug listing or a production enterprise of Chinese Medicine by assessing this work through the resources of Chinese Medicine which finally achieves the strategic significance of promoting the sustainable utilization of Chinese medicine resources. Under the guidance of the overall idea of "the total amount is not reduced and the supply is guaranteed", this paper focuses on the following two methods of assessment: ①"family property assessment" of Chinese medicine resources based on "fixed total amount". ② "Supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee". In this paper, we discuss the difference and relationship between the national survey of Chinese medicine resources and the assessment of Chinese medicine resources. Finally, we put forward a basic strategy called" supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee" that will guide the Industrial production of traditional Chinese medicine.

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