Drug safety is about people’s life, and implement of drug safety requires for the supervision throughout the whole supply chain. Today, the development of information technology makes management in time and beyond the control of space. Within an enterprise, the exchange of information from upstream and downstream for tracking product, which is named information flow management of supply chain is playing an enormous role. Similarly, government regulators could also use an electronic platform based on information technology to monitor drug distribution of products, thus achieve more strictly and effectively the safety of drugs. As the development of science and technology, regulatory policies on tracking of drug distribution in the supply chain have gradually promulgated in China in these years, which is referred to as’drug electronic supervision’in a document in2008.According to policy analytics thoughts on policy implementation, using the historical method, literature analysis, comparative research and theoretical research, this study analyzes the current situation of drug electronic supervision policy implementation in our country, aimed at pointing out the challenges and giving suggestions respectively.At first, based on the latest development of supply chain information flow management, and through field survey and expert interview, this study point out the difficulties of supply chain management in drug enterprises, from production, demand to logistics. Those difficulties as the direction of the follow-up study. At the same time, to our country electronic drug supervision policies, processes and the framework of exceed the time limit is studied also.Through literature analysis and case study, it concludes the current regulatory policies on supply chain of production, distribution and use of drugs. Results show that:the policy could improve pharmaceutical industry, large wholesale enterprises, chain pharmacies and medical organizations in their internal management level. However, small firms are difficult to face the reform, because of equipment cost and manpower cost. Thus, drug electronic regulatory policy execution bring about industry structure adjustment from multiple, small and scattered to the standard and scaled ones.According to current situation above, through the analysis of the dynamic resistance of the method of stakeholders (producing enterprises, trading enterprises and medical institutions and law enforcement), the influence factors of the drug electronic supervision policy has some problems to be implemented. Those are, the lack of relevant laws, regulations, supporting policies, new equipment investment costs, and low level of related personnel training and knowledge and so on.To solve these problems, learning from the mode of California and European’s, as well as the system of vehicle identification code in the enlightenment of anti-counterfeiting, multi-platform fusion, based on the existing problems, from the policies and regulations, regulatory concept, law enforcement inspection, finances and technology aspects put forward the following suggestions.1. Clarify all varieties of the whole process of drug electronic monitoring on the status of the pharmaceutical administration law, make the execution of each link has a foundation;2. In the new version of GMP and implement supply chain management concept, strengthen the drug electronic monitoring;3. Establish implementation of technical standards and standards of each link;4. Training for law enforcement supervision departments at various levels;5. Training of production enterprises, distribution enterprises and medical organizations when the clear benefits of electronic supervision;6. Clarify and carry out punishment according to the content and strength;7. Define responsibility and responsibility of the regulatory departments at all levels;8. Clarify pharmaceutical supervisory and administrative department of public health and responsibility of electronic supervision of medical institutions;9. Clarify the local drug regulatory departments of production enterprises, wholesale, retail enterprise of the investment of equipment support and solutions;10. Each link implementation system for nominating system integrators choice;11. Use the two-dimension code as the carrier label;12. Get the data ompatible with the system of administrative department for public health and drug electronic monitoring platform; and make pharmaceutical supervisory and administrative departments at all levels of the system compatible with the Chinese drug electronic monitoring network platform. |