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OBJECTIVE To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues. METHODS Based on literature research， practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed， and the problems existing in the application of the system were compared to propose corresponding solutions. RESULTS & CONCLUSIONS China has issued two batches of encouraged generic drug catalogues， and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues， there were some problems in legislation， incentive system for the first generic drug， post-marketing re-evaluation system， and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation， improve the “first generic market exclusivity period” system， perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety， effectiveness and accessibility of generic drugs in China.
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OBJECTIVE To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China. METHODS With text analysis， empirical research and other methods， the competitive generic drug incentive system in the United States was combed， its implementation effect and successful experience were analyzed， and the reference was provided for the implementation of relevant systems in China. RESULTS The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects： encouraging generic drug applications， accelerating the listing of generic drugs， and promoting drug price reduction， which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent，Off-Exclusivity Drugs without an Approved Generic， while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods. CONCLUSIONS China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore， we can refer to it， improve the system of releasing the catalog of encouraged generic drugs to be imitated， optimize the approval process for them， and authorize the exclusive period incentive to them.
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The right to informed consent is the basic right of subjects in drug clinical trials. International treaties and domestic laws have successively formed a basic right protection framework, while there are still some problems such as imperfect legal norms and incomplete practical operations. To meet future challenges, it is necessary to further improve legislation, standardize notification procedures, improve notification content, expand dynamic notification methods, and strengthen ethical review, so as to build a standardized and modern system for protecting the right to informed consent of subjects.
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Legal clinic education originating in the United States, aims at educating students on legal practical skills, and plays an positive role in cultivating students' ability of integrating theory with practice and training their various practical vocational skills. The present Chinese training mode of health law specialty does not perform very well in training students' practical ability, while legal clinic education can better make up for some deficiencies. Therefore, this paper learns from the experience of American universities in their legal clinic education, such as the particular division of specialties, the development of outside-school clinics, taking pre-training seriously, and the unique evaluation mechanism. Correspondingly, we explore to construct a set of reasonable legal clinic education system in health law specialty, including the orientation of legal clinics, the double training system inside and outside school, the construction of teaching staff and the establishment of evaluation mechanism.
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OBJECTIVE：To provide reference for perfecting regional cooperation supervision mechanism under the marketing authorization holder （MAH） system in China. METHODS ：Based on the analysis of legal responsibilities of the MAH and entrusted manufacturing enterprise ，the problems were studied and suggestions for improving the regional cooperative supervision mechanism were put forward. RESULTS & CONCLUSIONS ：Sub-contract production is the main target of cross-regional collaborative supervision of drug regulatory agencies. The MAH is responsible for the entire life cycle of the drug ，and the entrusted manufacturing enterprise assumes supplementary responsibility. At present ， the problems of regional cooperation supervision are lacking of targeted legal enforcement basis ，insufficient supervision power ，difficulty in obtaining evidence ， untimely supervision and inadequate department cooperation supervision mechanism. It is necessary to improve the regional cooperative supervision mechanism continuously in perspectives of perfecting legislation ，establishing professional inspector system，improving departmental linkage mechanism ，and strenghtening the database construction.
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Objective To evaluate the therapeutic effect of thymosin alpha -1 with glucocorticoid in treat-ment of HBV -related hepatic failure.Methods 130 cases were randomly divided into two groups,they were all giv-en antiviral therapy,protect liver,anti -inflammatory,yellow suit the back support,etc.comprehensive treatment;and patients in treatment group were given thymosin alpha -1 with methyl -prednisone intravenously at the early stage of treating process,and then observed the clinic situation and cure rate of those sufferers,The biochemiccal indicator, PTA and blood serum HBV DNA capacity ending with the period of 4 weeks were tested.Results In both groups,the TBil,TC in serum had apparently improved compared with the baseline after the medication,the difference was signifi-cant (t =3.12,P <0.05 and t =3.05,P <0.05).The time of gastrointestinal symptoms improvement and bilirubin subsided time in treatment group were significantly shorter than those of the control group(t =3.34,P <0.01 and t =4.52,P <0.01 ).During the treatment,there was no significant adverse reaction,and there were no differences between two groups in Alt,PTA,HBV DNA,infection,gastrointestinal bleeding,hepatic encephalopathy and hepatore-nal syndrome.The effective rate of treatment group was 75.2%,which was higher than 50.3% of the control group (χ2 =11.02,P <0.01).Conclusion Patients with HBV -related hepatic failure of short -term application of thy-mosin alpha -1 with glucocorticoid treatment,can quickly improve symptoms,greatly improve the efficiency of survival rate,shortem hospitalization period,reduce side effects and enhance security.
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There are three systems to protect the geographical indications of genuine medical materials in present China, which easily leads to the right-conflicts among several geographical indications rights. The situation is not reasonable, but is legitimate in the current legal system. So we should start from the present legislation and learn from foreign experience to resolve it step by step. To be specific, in the short term, we should strengthen propaganda and alter the existing logos to reduce the possibility of consumer confusion. Meanwhile, we should annul or revoke the registration of the improperly registered geographical indications. In the medium term, we should make some amendments to the legislation, that is, to give priorities to geographical indication products. At last, we should change the three systems into a single protection mode on the basis of the geographical indication products system.
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Moot Court practice teaching is an important part of the teaching of medical and health law. Based on several years of university students' participating in moot court competition, and combined with the personal experience of the instructors and the participating students, we summed up our inexperience of medical law moot court practice teaching, and put forward feasible suggestions to professional Moot Court simulation practice teaching reform of Health Law in order to effectively improve the medical and health professional moot court practice teaching, thus implementing the law to strengthen the students practical skills trainingteaching objectives.
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Health law teaching exists deficiencies in training students' practical ability while moot court has obvious advantages in this area and it is feasible. Specific program can be established from the following four aspects:curriculum mode,selection of cases,teaching methods and evalua-tion system.