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Research on the Method of Secondary Development and System Building of Chinese Patent Medicine

Author: ZhangJingZuo
Tutor: SongMinXian
School: Chengdu University of Traditional Chinese Medicine
Course: Of Pharmacy
Keywords: Proprietary Chinese medicines Secondary development Defect Laws and regulations
CLC: R288
Type: Master's thesis
Year: 2010
Downloads: 97
Quote: 0
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Abstract


Since 2007 , after the promulgation of the \The new drug registration regulations to encourage change formulations significantly improve drug quality , safety and efficacy of the application , containment simple change formulations , and to some extent reduce the number listed for a simple change dosage form drugs , posed a great challenge to the pharmaceutical industry also avoid homogeneous competition intensifies . Companies wishing to maintain their own advantages to this policy , it is necessary to develop new drugs or a solid market position of the original drugs . Need to marketed drugs for secondary development. The purpose of this project : secondary development through the production of proprietary Chinese medicines , for approval , the use of the status quo to summarize the analysis of defects explore the proprietary Chinese medicines and precautions . And the lack of proprietary Chinese medicines secondary development of laws and regulations , management system . Proposed to improve the system and drug re-evaluation of the adverse drug reaction reporting system to norms the drug secondary development of behavior , to ensure the safety of the drug in patients , to reduce the risk of responsibility . : The use of proprietary Chinese medicines , starting from the existing lack of finishing secondary development of proprietary Chinese medicines mode , clear imperfections in secondary development of laws and regulations and management system . Results: no sound legal system and management system to regulate the secondary development of proprietary Chinese medicines . Conclusion: The lack of proprietary Chinese medicines , Chinese medicine theory foundation guidance production and use will bring huge liability risks . Re- evaluation of the system by the sound of adverse drug reactions reporting system as well as the drugs , and drug use to a comprehensive and accurate understanding for the enterprise . Companies as a basis for secondary development of medicines more scientific and reliable .

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CLC: > Medicine, health > Chinese Medicine > Of Pharmacy > Chinese medicine pharmacy organizations
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