Research On Quality Of Pharmaceutical Production Enterprise Authorized Person System Construction

The quality of medicines is closely related with people’s health and safety. Supervision and management on the quality management system of pharmaceutical manufacturer is not only a management model for the starting point of the industry chain of the pharmaceutical industry, but also the most fundamental form of regulation. After a series of injury events, the qualified person system was introduced from the EU, hoping guide enterprises to improve their quality management system. However, problems still exist in the designing and implementing of the qualified person system. For this reason, it has a very clear practical significance that using a higher perspective, a wider range of reference to analyze the qualified person system and then providing a valuable reference and operable proposal.On the basis of defining the scope, the study was conducted in three dimensions:a longitudinal study (study on the history of system), depth study (empirical research on the designing and details of implementation), horizontal study (comparative analysis of international experience and related fields).In the longitudinal expansion, based on the development of pharmaceutical supervision and management system, the study analyzed the progressiveness and limitations of qualified person system, and compared the existing system in domestic provinces at the design level. It was found that the qualified person system was designed to meet the progressive trend from discontinuous sent-style regulation to the long-term spontaneous one. But meanwhile, there are also some problems, e.g. the imperfection of institutional system, the unclearly positioning of functions, unreasonable eligibility requirements, lacking of administrative restriction etc.In the depth expansion, the study conducted investigations in the implementation of the system in Guangdong and Shanghai and found that the current system is insufficient to implement, and the positioning of qualified person is not clear, the initial experience of the pilot provinces can hardly be copied by others.In the horizontal expansion, through the study of qualified person system of EU, it was found that the purpose of the system in China (improve the quality management system of pharmaceutical manufacturer) is different from that in EU (unify the different quality standards of the member states). Our current model is more similar to that in France (different from the EU’s general situation). In addition, referring to the stock market, the relevant experience in supervision and management system gave some innovative inspiration in system designing, such as the exemption system, salary changes, and record of integrity.On the basis of the research in3dimensions, the study also analyzed the problems in design and implementation of qualified person system from the view of economics and management theory, models and research results (such as asymmetric information theory, bounded rationality, opportunism theory, game theory, etc.). Eventually the following recommendations were made:improving the construction of qualified person system, clarifying the legal status, legal responsibilities and positioning of the qualified person through strengthening legislation, promoting the formalized and professional development of the qualified person through improving the institutional framework of the system, setting the access system for vocational qualifications; strengthening the administrative intervention during the introduction of the system, guiding enterprises to build the authorized management team, integrating the qualified person system with other existing regulatory system; changing the incentives and accountability of qualified person, rationalizing the implicit conflict of duties.