ABSTRACT
OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.
ABSTRACT
Objective:This paper aims to analyze the related effects of the low price medicine policy, and prob-lems in the implementation process. Methods:To retrieve an official website of the state food and medicine supervi-sion and administration, collect the package supplements of the low-price medicines and analyze their varieties according to their situations, and calculate he highest and lowest average daily use indicators for the medicine, etc. from January 2009 to August 2014. Results:(1) The low-price medicine list contains 533 kinds of standard medi-cines, and the coincidence rate with the essential medicines list is 51. 59%. Results also show that 96. 82% of the low-price medicines are incorporated into the national medical insurance directory. ( 2 ) The daily medicine cost difference of the maximum and minimum bidder price to the same medicine produced by different manufacturers ran-ges from 0. 01 to 30. 96 Yuan with 94. 76% of the western medicine dosage constituting the existing price rise space. (3) The daily medicine cost difference ranges from 0. 01 to 19. 35 Yuan with 92. 13% of the proprietary Chinese medicine varieties constituting the existing price rise space. Discussions:The low-price medicine varieties lack in the strict proof, the fact of low pricing the medicine has a two-way effect, and the connection between the low-price medi-cine administration policy and other policies is unclear.
ABSTRACT
This study was aimed to carry the post-marketing revaluation on classical Tibetan medicine of the Seven-ty-flavor Pearl Pill, which will help improve its scientificity, safety and standardization in order to promote its indus- trial development. Literature mining method was used to summarize research information of the Seventy-flavor Pearl Pill, such as the clinical pharmacy sorting. Meanwhile, the successful example of Padma-28 was referred in the analysis of deficiencies in the indications of Seventy-flavor Pearl Pill. The results showed the present situation of clinical combination therapy, pharmacology and toxicology study of Seventy-flavor Pearl Pill. It was concluded that the building of new model of post-marketing revaluation on the Seventy-flavor Pearl Pill can provide re-evaluation scientific basis for Tibetan medicine on its clinical effectiveness and safety.