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OBJECTIVE：To pr ovide reference for improving extended clinical trial system in China. METHODS ：The implementation experience of the international extended clinical trial system was introduced from three aspects ： system development，application scope and principles ，application and approval ；the evolution and challenges of the system in China were further analyzed ，and relative suggestions were put forward. RESULTS & CONCLUSIONS ：The development of international extended clinical trial system in the United States ，the United Kingdom ，Australia and the European Union had been relatively mature. The specific system had not formally been established in China ，and the implementation of the system faced many challenges，such as the ethical problems caused by drug use risk ，the sponsor dilemma caused by the difficult balance between the resistance of initiating application and the benefits ，the difficulty of review caused by the unknown responsible party of risk assessment and the urgent time of approval. It can be dealt with by the following measures ：improving the existing laws and regulations，strengthen information disclosure and risk prevention work ，make clear the division of responsibilities in the process of system operation. Meanwhile ，based on the existing international model ，the management system of the expanded clinical trials in China is established. Corresponding application paths are set up for different application types such as “single patient emergency ”， “single patient non emergency ”and“two or more patients group ”，and all parties should be mobilized to supervise so as to promote the improvement and implementation of the extended clinical trial system.
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OBJECTIVE： To provide reference for the thought and operation of the law to protect the tacit technology secrets of traditional Chinese medicine （TCM）. METHODS： Through the analysis of the composition， categories and legal attributes of tacit technology secrets of TCM， legal protection methods were sought from the legal perspective. RESULTS & CONCLUSIONS： In the field of TCM， tacit knowledge， represented by the TCM processing， TCM diagnosis and treatment， is mostly inherited and studied in the form of technology secrets. The tacit technology secrets of TCM have the characteristics of personality dependence and inheritance， the protection of them by law can not be achieved directly through the field of intellectual property rights， but through the protection of the interests of the inheritors. Public law and private law are indispensable to the protection of tacit technology secrets of TCM. Public law should focus on improving the mechanism of technological inheritance and protecting the rights and interests of TCM inheritors. Private law should overcome the risk of infringement by signing contracts and transforming tacit knowledge of TCM.
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OBJECTIVE:To provide reference for improving legal protection system of proprietary technology in TCM time-honored enterprises. METHODS:By studying the relevant literatures and data,main type of proprietary technology,formula, legal characteristics of processing technology in TCM time-honored enterprises were analyzed;the protection forms and existing problems of proprietary technology were summarized to put forward countermeasures. RESULTS & CONCLUSIONS:The most important proprietary technology of TCM time-honored brand is formula and TCM processing technology,and legal characteristics of it include practicality,value,confidentiality and teachability. The proprietary technology protection of TCM time-honored brand included various methods such as business secret,patent protection and administrative protection. But,there still are problems such as the incompatibility of patent protection,the conflict between the secret protection and information disclosure,gradually weakened means of administrative protection,weak awareness of legal protection in time-honored brand of TCM. It is suggested to use comprehensive protection means of patent system and business secret,coordinate intellectual property protection and administrative protection,establish proprietary technology protection directories and databases and incentive and constraint mechanism of internal intellectual property rights in enterprises so as to seek effective way to protect proprietary technology of TCM time-honored brand.