| Drug regulation is essential to guarantee the health and safety of the people. And Good Manufacturing Practices standard (GMP) is a link in the production chain of drug administration supervision and management of the whole process, which is the most important aspect in drug regulation.In 1988, China promulgated its first drug GMP, and in 1999 all drug manufacturers were forced to certify the 98 edition of GMP, in 2011 began to implement version 2010 GMP. Currently, it is the version 2010 GMP implementation occasion for the pharmaceutical manufacturers.Besides the policy formulation and implementation, GMP as a complete policy process, also needs scientific assessment for its policy and policy activities, in order to determine the value of the GMP policy itself, to decide its continuer, innovation.Currently, there are various ways of policy evaluation, through the study of foreign policy evaluation approaches, and learning of the advanced countries policy assessments, this study aim to use Beijing as the assessing object, by using quantitative and qualitative analysis policy evaluation method, using the current mainstream Western policy evaluation method, namely the cost-benefit analysis, To do the policy evaluation for the GMP(2010 edition) on this policy inputs, outputs and impaction, to test whether the development and implementation of the version 2010 GMP is successful or not. Understanding the issues and challenges faced during the process of implementation. This work can accumulate policy experience and support for the future policy establishing.[objective] This study was based on the content of the version 2010 GMP, which was promulgated in 2011, combined with the implementation of the Beijing drug manufacturer version 2010 GMP, using the cost-benefit analysis approach, to assess the relationship between the ruling cost and performance of the version 2010 GMP, in order to establish a relatively workable policy assessment model to better improve government management system, and increase the level of policy.[Methods] This study was based on literature analysis, field research, surveys, special interviews, expert evaluation and other methods. Through literature reserch, studying the GMP, using "cost-benefit" analysis, combined with practical work of Drug Administration, to form a preliminary questionnaire. Do pre-research and visiting drug manufacturers, according to the interview to revise and improve the question naire. Then issued to businesses, fill questionnaires, combining field visiting approach, collecting information from all around. After data processing, statistical analysis, we successfully complish this work.[Research] The difference study on content of the edition 98 GMP and version 2010 GMP, comparing the main changes content of the two version to discover, in what areas, the standards of new GMP improved than the version 98, and analyse these changes.Doing cost-benefit impact studies of the pharmaceutical manufacturing enterprises in Beijing, based on version 2010 GMP for. The main input cost is calculated in terms of hardware, software, personnel, etc., and the net profits was generated from the production output, sales, and profits, and so on.[Resutsl]Compare with the version 98 GMP, the new version of GMP has a substantial increase in the number of terms, and the requirements are more detailed, actionable. New GMP put forward higher requirements in terms of software, which is the main feature of version 2010 GMP.Investment costs:The version 2010 GMP renovation costs is significantly higher than the inputs of version 98 GMP certification cost. As in the allocation of funds, the vast majority of funds are spended on the transformation of the hardware facilities, followed is software and person. But the differences in terms of staff input of these two certified hardware investment is not obvious, major differences appears in the software transforming inputs.Benefits obtaining:the average production value and sales amount of enterprises were in a gradually increasing trend, while the rate of increase has expanded each year. The gross profit and net profit also increased year by year, but the rate of increase is relatively flat. Although the hardware investment costs produced a negative effect in 2012, but the reversed role of corporate profits in 2013 the hardware investment costs are decreased gradually, the reverse effect will decrease year by year, and then transferred to a positive effect. View from the parameters of software input costs and staff input cost, both of them have positive effect on corporate profits, and software investment costs changed from no significant effect, into a significant positive impact, positive impact on staff input costs significantly expanded, this shows that the initial investment in software and personnel of enterprises can have a positive effect on the development of enterprises in the latter time. In addition, the corporate upfront investment in infrastructure such as hardware configuration, although it will reduce corporate profits in a short term, but from long-term view it will still have an active effect.[Conclusion] To do the new GMP certification, business is needed to pay a certain cost, may reduce profitability in a short term, increase the cost burden, but in the long term, certification of the new GMP will have benefit for the company’s future on the basis of production capacity profitability, quality of personnel, quality of medicines and other aspects. It is very favorable to promot the long-term development of the pharmaceutical companies.
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