RESUMEN
OBJECTIVE: To provide reference for China to comprehensively promote and perfect the "two-vote system" for drug purchase. METHODS: The effects of "two-vote system" on interested parties, the existing problems of drug purchase and its financial reasons were analyzed; the finance strategies were put forward to deal with the existing problems of drug purchase. RESULTS & CONCLUSIONS: "Two-vote system" has certain impact on drug production enterprises, drug circulation enterprises, public medical institutions and government drug supervision departments. At present, the existing problems of drug purchase mainly include that the mechanism of "drug to support hospital" has promoted the virtual-high price of drugs; drug enterprises pull drug sales by the way of rebate; hidden rules disrupt the circulation of drugs as "be subordinate to" "amateur performance". Financial reasons mainly include that the mode of "drug to support hospital" pursuit the maximization of its own interests unilaterally and ignore the drug cost burden of patients; some enterprises have poor investment, lack of R&D investment, have weak internal financial control measures, lack of social responsibility consciousness, rely on "be subordinate to" "amateur performance" profit, underestimate financial risk, etc. The drug production enterprises should adjust marketing model and reduce cost; drug circulation enterprises should predict positioning scientifically and expand profit space; public medical institutions should reform financial supply and reduce drug cost; government drug supervision departments should reduce the supervision cost and improve the comprehensive efficiency. Only by deepening the reform of the medical and health care system, improving the supporting measures for the "two-vote system" in drug purchase can the problems existing in the circulation of drugs be solved gradually.
RESUMEN
Processing technology of Chinese herbal medicine is the unique pharmaceutical technology in China.Chinese herbal pieces production enterprises are the main carrier of processing technology.Reasonable and normative master and use of the processing technology by production enterprises can directly affect the quality of Chinese herbal pieces and the clinical efficacy.Therefore,it is necessary to carry out investigation on the processing technology of Chinese herbal pieces production enterprises.In order to better inherit and develop processing technology,to promote the development of Chinese herbal pieces production enterprises and to ensure the quality of pieces,the general situation and existing problems of Chinese herbal pieces production enterprises were identified,concluded,summarized.Relevant countermeasures were put forward by carrying out investigation in Chinese herbal pieces production enterprises.
RESUMEN
OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.