With the construction of a pluralistic value system， the concept of patient autonomy has gradually been established. The paternalistic medical decision-making model has been widely questioned and criticized， gradually losing its dominant position. Due to the differences in positions and values， there are conceptual differences and decision-making conflicts between doctors and patients， and the doctor-patient game runs throughout the entire medical decision-making process. However， after analyzing the advantages and disadvantages of both the paternalistic medical decision-making model and the patient autonomous decision-making model， it can be found that blindly devaluing any medical decision-making model is not the optimal solution to maximize patients’ rights and interests. The medical side needs to fully respect patient autonomy， while the patient side should also clarify the concept of equal rights and responsibilities. Through the optimization of the policies and systems， both doctors and patients can cultivate independent decision-making personalities and rational thinking abilities， ultimately achieving doctor-patient consensus through equal dialogue and communication.

The use of off-label drugs， which accompanies the approval system for new drugs entering the market， is widespread in clinical practice in China， and the resulting medical damage liability is also controversial in theory and practice. Based on 129 judicial cases from 2014 to 2023， this paper conducted a quantitative analysis of medical damage liability caused by off-label drug use. Through sorting out， it was found that the cases of off-label drug use presented obvious characteristics in types and regional distribution， and their damage consequences and appeal rates were far higher than those of general medical damage cases， which need to attract more attention. Based on the liability reasons， this paper further categorized the cases into three types： no liability， single liability， and multiple liabilities. The number and liability ratio of off-label drug use under different liability types were analyzed， and the key factors affecting the establishment of medical damage liability for off-label drug use were sorted out and analyzed in depth. These key factors included the existence of off-label drug use and a clear causal relationship between off-label drug use and medical damage， inadequate informed consent， and lack of sufficient and solid evidence-based medical support. Additionally， it was confirmed that a medical ethics review is not a prerequisite for the legality of off-label drug use. Finally， recommendations for off-label drug use in clinical practice were proposed， such as ensuring timeliness， adequacy， and formality of informed consent， adhering to a clear causal relationship construction， as well as sorting out the scope and effectiveness level of evidence-based medicine to establish industry self-consistency.

Currently，there are still obstacles for patients’ right of self-determination in medical decision-making. By sorting out its historical origins，this paper found that the reasons for the current situation mainly include the influence of familial culture and medical paternalism，as well as the constraints of the behavioral capacity system and the guardianship systems. In this context，this paper criticized the view that “the key to enjoying decision-making power is rationality”，and called for a return to the concept of patient autonomy，so as to achieve a balance between agency decision-making power of others and the special intervention rights of doctors. The legal system for resolving conflicts can be constructed by replacing behavioral capacity with medical decision-making ability，requiring the evaluation of medical decision-making ability based on actual conditions，establishing a pre-medical instruction system，and clarifying the boundaries of medical special intervention rights.

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.

The legitimate rights of mental health workers don't get expected protection,which has caused negative influence on the development of mental health work.By introducing the Gantt v.Arnie Sethcase,we an-alyzed the law applicable disputes of doctors who are hurt by the patients with mental disorders,and made legal e-valuation on the views of relevant responsibility identification at home and abroad,and attempted to come up with some suggestions on construction of legitimate interest safeguard mechanism for mental-health workers from the as-pects of legislation and administrative policy.