ABSTRACT
On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.
ABSTRACT
OBJECTIVE： To provide reference for pharmaceutical manufacturers improving the quality system of GMP and drug regulatory departments improving their supervision level. METHODS： Through analyzing and summarizing the problems existing in the 28 pharmaceutical enterprises which had been published on the website in the National Medical Products Administration from February 6th， 2018 to January 25th， 2019， the common problems were found and their causes were analyzed， then the regulatory countermeasures were put forward. RESULTS & CONCLUSIONS： Pharmaceutical enterprises have some problems of inadequate implementation of GMP， such as the inadequate performance of personnel in key positions and the unsatisfactory training effect of relevant personnel， the inconsistency between actual production technology and approved legal technology， the non-standard management of enterprise materials， the incomplete batch production records and the inability to effectively monitor the production cycle. However， there are also some problems in the supervision department， such as the large difference in the scale of inspectors’ on-site inspection， the need to strengthen the inspectors’ inspection ability and level， and the lack of innovation in the means of supervision. It is suggested that pharmaceutical manufacturers should improve the construction of GMP quality management system and strengthen the training of relevant personnel； the regulatory authorities should continue to promote the reform of “release， control and service”， strictly enforce the access conditions of inspectors， strengthen the training of inspectors and ideological construction of the inspector team，further strengthen the construction of supervision system and enhance the innovation of supervision means， so as to jointly maintain the safety， effectiveness and quality controllability of medicines.
ABSTRACT
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.
ABSTRACT
In this paper,the management process of Chinese-Western medicine compound preparation is briefly reviewed.the existing problems were analyzed from the perspective of registration supervision and quality control.It is pointed out that there are still some types of management in the registration of supervision,such as the weak basic research,approval number of multiple pecifications,not uniform name,and not standardized specification.In the area of quality control,correlation analysis between the lack of key items (such as related substances,uniformity of contents,and dissolution test items) and the hidden dangers in medical security of preparations was performed.To explore the need for reevaluation,and put forward some suggestions for improvement in order to provide a useful reference for the scientific supervision of Chinese-Western medicine compound preparation.
ABSTRACT
Food and drug supervision is a specialized job. However, the present supervisors coming from various departments have differences in supervision concepts, professional background, knowledge structure and work experience, which shows large gap with the requirements of supervision work. Therefore, it is urgent to strengthen the classified training for the improvement of quality construction and specialization. The article provided the curriculum system, teaching explanation and ideas about the classified training for all supervisors in the whole system, which may be beneficial to the training of food and drug supervisors.
ABSTRACT
Through searching literature and analyzing documents, the system of drug supervision in Germany and British was analyzed, and the conspicuous features in drug supervision were obtained. Experiences of drug supervision were summarized.Germany and Britain, as representatives of developed western countries, have established wholesome supervision system and mature supervision pattern, which are continuously developed and improved in practice. Drug administration experiences of Germany and Britain provide beneficial reference to drug supervision in China.
ABSTRACT
The sound implementation of a legal system depends on scientific ideas and an efficient supervision system. Presently, the drug supervision system is a period of transition, with the prospects of establishing a modern supervision system that incorporates the ideals of risk management. To this end, the responsibilities of the drug super-vision agency shall be adjusted horizontally and vertically so as to enhance the efficiency of supervision and to avoid an overlap of functions or supervision vacancy. We should enhance the capacity for governance and cultivate the self-discipline of the industry and associations. The implementation of administrative accountability is necessary to ensure that institutional responsibilities are fulfilled and thereby realize public health.
ABSTRACT
Objective:To understand the training needs of basic food and drug supervision personnel to provide guidance for the future textbook compiling and training. Methods:The work, training and learning needs of basic food and drug supervision personnel were investigated using the questionnaire survey in the director of the county bureau. Results:The difference in the professional back-ground among the supervision persons and the training were significant in different areas. Conclusion: By strengthening training and textbook construction, the ability of basic food and drug supervision personnel can be enhanced and the supervision and regulation level can be improved as well.
ABSTRACT
OBJECTIVE:To put forward suggestion for establishing public interest litigation system in drug supervision and administration field in China.METHODS:Literature research and comprehensive analysis were applied to analyze the relationship between the problems of drug supervision and administration field and defect of drug supervision and administration system.And then the necessity of public interest litigation system in drug supervision and administration field was also analyzed.RESULTS:There are some serious problems which impact on people's lives and health,such as weak drug quality control,fake drug advertisement continuing to exist after repeated prohibition and right abuse of drug supervision and administration,etc.These problems may be associated with the defect of drug supervision and administration system such as defective administration system,ineffective administration,ect.A new system should be established.The public interest litigation system has the advantage of dealing with these problems.CONCLUSION:It's necessary to establish the public interest litigation system to improve the unsatisfactory situation in the field of the drug supervision and administration.
