Study On Raising Value Chain Of Middle And Small Pharmaceutical Manufacturing Enterprises Under New CFDA Policies

During the period of "12th Five-Year Plan",China's pharmaceutical industry had achieved good results,but there are still some outstanding problems such as low innovation,low product quality,homogeneous products,multiple and small and scattered enterprises.During the period of"13th Five-Year Plan",There are five good opportunities for development about growing of market demand and accelerating of technology progress and a favorable industrial policy and strengthening of industry supervision and improving of health reform policy in China's pharmaceutical industry.But there are various constraints,especially a series of regulatory CFDA policies have had profound impacts on the threshold of pharmaceutical R&D and registration,innovation ability,product quality level,industrial organization structure and international development level about pharmaceutical manufacturing enterprises.Facing new CFDA policies,China's pharmaceutical manufacturing enterprises,especially middle and small enterprises have a problem of raising value chain.Therefore,it is urgent to study this aspect.This paper is based on the research results of raising value chain theory,it is studying to raising value chain of middle and small enterprises by literature research method and theoretical analysis method and case study method.First of all,it analyzes the status of value chain of China's middle and small pharmaceutical manufacturing enterprises,they are main problems of value chain of "R&D and registration of pharmaceutical" and "consistency evaluation of generic drug quality and efficacy" etc.,proposes that it raises the value chain by adjusting or strengthening "R&D and registration of pharmaceutical",developing "consistency evaluation of generic drug quality and efficacy",actualizing "MAH",developing foreign quality certification,expanding industrial chain etc.main activities.Secondly,it analyzes the macro and micro environment of C company by PEST and SWOT method,builds and analyzes the value chain of C company,points main activities for raising the value chain of C company,rebuilds and analyzes the value chain of C company.Thirdly,it proposes that the strategies of raising value chain of C company are building "research resources of pharmaceutical" and "MAH resources" and "production and quality resources of pharmaceutical" and "sale resources of pharmaceutical" and "intangible assets resources",carries on the investment estimate to the production of drugs,points that each technical and economic index is better than the industry benchmark.Finally,proposes that the safeguard measures are fund guarantee and organization guarantee and talent guarantee and system guarantee and enterprise culture guarantee.By the study,it thinks that research results of this paper are feasible to raise the value chain of C company,the core strategies and safeguard measures of raising value chain are generally applicable to various pharmaceutical manufacturing enterprises,therefore,the research of this paper should provide reference for other enterprises.