Relationship of Ecosystems and Resolution of New Drug Research and Development
TAO Xiu-mei1, DONG Jiang-ping2, HUANG Lei 3, JIANG De-yuan1*
1.China Food and Drug Administration Institute of Executive Development, Beijing 100073, China; 2.Department of Drug Registration, China Food and Drug Adminstraion, Beijing 100053,China; 3.Beijing Nuokangda Pharmaceutical Technology Co., Ltd., Beijing 100176, China
Abstract��OBJECTIVE Relationship of ecosystems and resolution of new drug research and development is analyzed through a comparison of the clinical needs, industry development policy, enterprise-self factor, listing application mechanism, number and characteristics of new drug in America and China, especially, the market conditions of the me-only, me-better and me-too between America and China is analyzed importantly. The idea that the new drug is studied and developed in China is presented. METHODS The important influencing factors that affected the ecosystems of new drug research and development were analyzed by comparison METHODS and data studies. RESULTS The clinical availability of new drug in America is significant increased recently and over 90% applied new drugs can be finished in a limited time based on the evolution of the innovative ecological environment of new drug research and development from 1993 to 2014, new drugs are approval listing in America and China respectively. CONCLUSION The availability of new drug is very important to a state security. The ecosystem of new drug research and development is very complicated. The relative field in America is more advanced than in China and it is used for reference to the new drug research and development in China.
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TAO Xiu-mei, DONG Jiang-ping, HUANG Lei , JIANG De-yuan. Relationship of Ecosystems and Resolution of New Drug Research and Development. Chinese Pharmaceutical Journal, 2016, 51(7): 592-597.
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