A Study On Current Situation And Regulation Countermeasure Of Medical Preparations

Medical institutional preparations have irreplaceable advantages over the marketing Pharmaceuticals. First, these preparations are designed for specific diseases and specific groups of people, and which is also easy to integrate into clinical practice. Second, medical preparations (especially traditional Chinese medicines) have shown more effective than the marketing pharceutical counterparts for the treatment of a number of clinical chronic diseases. Third, the low cost of many medical preparations can alleviate the emerged "high cost of medical treatment" issues during the current health care reform process. Moreover, medical preparations have play important roles in preventing and curing sudden group diseases such as "hand, foot and mouth" disease and H1N1 influenza. The great beneficial effect of medical preparations in clinical practice has been manifested for hundreds of years, however, the production of medical preparations has been shrinked for various reasons in recent years. Therefore, it is important to study the current situation and regulation countermeasure of medical preparation.Data and MethodsThe data set of this study is generated from published or unpublished literature, policy analysis, medical preparation database and institutional survey. To better understand the current situation and regulation countermeasure of medical preparations in Shandong Province, the institution survey was conducted which covered 119 reprentative medical institutions.Main resultsIn the first part, the policy evolution of medical preparations in China and Shandong Province and the problems faced by the development of medical preparation in Shandong province was reviewed. In the second part, the number, formulations and region distribution of "Preparation Certificate for Medical Institutions" and "Medical preparations Approval Number" were analyzed based on the medical preparations database. The information of medical preparations revenue, infrastructure, human resources and other aspects of sample medical institutions were also investigated in this part. In the last part, the history and current situation of medical preparations employed SWOT-PEST were studied. Finally, this study summarized the problems and provides relevant suggestions for the further development of medical preparations from the point of medical institution, social surveillance and regulation agency.Conclusions and policy suggestionThis study indicates that the integrated regulation from self-discipline of medical institution, social supervision and regulation of Food and Drug Administration agency is essential for the development of medical preparations, and this cooperative management from all of these three sides is the key to reach the optimal effectiveness of medical preparations.