| Since 2016,China began to pilot Marketing Authorization Holder(MAH)system,this is a system reform of the pharmaceutical industry,which will promote the development and use of external resources,promote the industrial chain division of refinement,and bring opportunities to the development of the pharmaceutical production by CMO in China.To understand the development trend of drug consigned production under MAH system has become the urgent need of pharmaceutical enterprises.Japan,which is not only a neighbor of China,but also has similar development experience in drug review and supervision system,has been implementing MAH system since 2005.Accordingly,study the history of Japanese policy and major changes of the pharmaceutical industry after MAH implementation in Japan has certain reference value as "Stones from other hills may serve to polish the jade of this one.".After MAH's implementation,the production volume of the CMO business will be spurt,and the development of drug industry will present a new trend.On the side of the owner,whether the production is done by itself or the production is commissioned,how to choose the production system will become an important business subject of the enterprise.On the side of the contract manufacturer,there will be a variety of companies involved in contract production,and specializing in CMO business.As the competition in the CMO market intensifies,if a pharmaceutical CMO enterprise wants to expand production capacity and business volume,the way to acquire the factories owned by well-known pharmaceutical companies is favored.The transformation from CMO to higher value-added CDMO will be the new strategic direction.The research results of this paper have some guiding significance on the business adjustment and strategic planning of China's pharmaceutical enterprises and can give reference to the enterprises in the planning of CMO business. |
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