Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.

Objective:The impact and mechanism system of the National Centralized Volume-Based Procurement(NCVBP)on innovation investment in pharmaceutical companies.Methods:Based on listed company data from 2015 to 2023,it uses the first eight rounds of NCVBP as a quasi-natural experiment and applies a staggered difference-in-differences model to control the industries and year fixed effects,test the impact of NCVBP on innovation investment in pharmaceutical companies,conduct the parallel trend and placebo test,and verify the robustness of the results.Results:The innovation investment of the winning enterprises was significantly increased by NCVBP.The ratio of Research&Development expenses to operating revenues of winning firms in the next quarter increases by 1.4%.The centralized procurement promotes innovation investment by enhancing the cost efficiency of enterprises and strengthening market competition in the industry.Conclusion:Collective purchasing significantly increases the innovation investment of winning enterprises,the improvement of cost efficiency is an important influence path to improve the innovation investment of enterprises.The industry market competition has a significant moderating effect on the collective purchasing and the innovation investment of enterprises;the national drug collective purchasing system can be improved from the aspects of innovation incentives,communication system,market competition,and so on.

Pharmaceutical patents,as a critical mechanism to incentivize medical innovation,carry complex ethical considerations due to their close association with humans'basic rights to life and health.The conflicts between rights to life and health and patent rights,the imbalance in drug accessibility caused by patent protection,the abuse of the patent system in practice,and the ethical risks of patent information asymmetry together constitute the primary obstacles to the healthy development of pharmaceutical patent ethics.Responsible innovation,as a comprehensive governance strategy,provides theoretical support for the ethical governance of pharmaceutical patents through its framework of anticipation,reflection,deliberation,and responsiveness.Drawing on the practical cases of the Supplementary Protection Certificate system in the European Union and the drug patent linkage system in the United States,this paper explored the methodology for implementing ethical balance under the framework of responsible innovation.Based on these,recommendations were proposed to improve China's pharmaceutical patent ethical governance system,including improving the pharmaceutical patent linkage system and presetting a new patent licensing framework to enhance the orderliness and predictability of pharmaceutical market access;establishing a social impact assessment system and an ethics review committee to continuously reflect on the effects of the pharmaceutical patent system on price,accessibility,and ethics;creating a multi-party consultation platform to promote information sharing and technical cooperation and ensure a balance of interests among all parties;and establishing an emergency response team and optimizing the compulsory licensing procedures to flexibly respond to changes in public health needs.

Objective:The impact and mechanism system of the National Centralized Volume-Based Procurement(NCVBP)on innovation investment in pharmaceutical companies.Methods:Based on listed company data from 2015 to 2023,it uses the first eight rounds of NCVBP as a quasi-natural experiment and applies a staggered difference-in-differences model to control the industries and year fixed effects,test the impact of NCVBP on innovation investment in pharmaceutical companies,conduct the parallel trend and placebo test,and verify the robustness of the results.Results:The innovation investment of the winning enterprises was significantly increased by NCVBP.The ratio of Research&Development expenses to operating revenues of winning firms in the next quarter increases by 1.4%.The centralized procurement promotes innovation investment by enhancing the cost efficiency of enterprises and strengthening market competition in the industry.Conclusion:Collective purchasing significantly increases the innovation investment of winning enterprises,the improvement of cost efficiency is an important influence path to improve the innovation investment of enterprises.The industry market competition has a significant moderating effect on the collective purchasing and the innovation investment of enterprises;the national drug collective purchasing system can be improved from the aspects of innovation incentives,communication system,market competition,and so on.

Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.

Pharmaceutical patents,as a critical mechanism to incentivize medical innovation,carry complex ethical considerations due to their close association with humans'basic rights to life and health.The conflicts between rights to life and health and patent rights,the imbalance in drug accessibility caused by patent protection,the abuse of the patent system in practice,and the ethical risks of patent information asymmetry together constitute the primary obstacles to the healthy development of pharmaceutical patent ethics.Responsible innovation,as a comprehensive governance strategy,provides theoretical support for the ethical governance of pharmaceutical patents through its framework of anticipation,reflection,deliberation,and responsiveness.Drawing on the practical cases of the Supplementary Protection Certificate system in the European Union and the drug patent linkage system in the United States,this paper explored the methodology for implementing ethical balance under the framework of responsible innovation.Based on these,recommendations were proposed to improve China's pharmaceutical patent ethical governance system,including improving the pharmaceutical patent linkage system and presetting a new patent licensing framework to enhance the orderliness and predictability of pharmaceutical market access;establishing a social impact assessment system and an ethics review committee to continuously reflect on the effects of the pharmaceutical patent system on price,accessibility,and ethics;creating a multi-party consultation platform to promote information sharing and technical cooperation and ensure a balance of interests among all parties;and establishing an emergency response team and optimizing the compulsory licensing procedures to flexibly respond to changes in public health needs.

As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the quality of Chinese herbal medicines is related to the development prospect of Chinese medicine industry in China. With the rapid development of new technologies such as traceability methods and monitoring instruments， it is imperative to integrate and innovate traditional Chinese herbal medicines with new-generation information technology in view of the quality problems existing in the current production and circulation of Chinese herbal medicines， and it is of great significance for the construction of traceability system to ensure the quality and safety of Chinese herbal medicines and to promote the industry of Chinese herbal medicines to move towards high-quality development. This paper reviews the development history of the traceability system of Chinese herbal medicines in China， takes the influencing factors of the quality of Chinese herbal medicines as the entry point， and proposes that the construction of the traceability system should satisfy the traceability requirements of the characteristics of Chinese herbal medicines and their traditional medication experience. By analyzing the influencing factors of the quality of Chinese herbal medicines， it is pointed out that focusing on the influencing factors to build a traceability system is of great significance for targeting the problematic links at a later stage and exploring the interrelationship between environmental factors and the quality of Chinese herbal medicines. Based on the previous explorations， the author summarizes the system framework， functional modules and practical applications of the traceability system of Chinese herbal medicines， and looks forward to the development of a traceability system with risk early warning function and expert decision-making function in its functional development. Finally， based on the factors affecting the quality of Chinese herbal medicines， the author puts forward several thoughts on construction of the traceability system， and makes an in-depth analysis and puts forward a solution for the current situation that a unified， standardized and universal traceability system has not yet been built， with a view to providing ideas and references for the construction of traceability system of Chinese herbal medicines.

The revised revision of the Shenzhen Special Economic Zone Medical Regulations passed in 2022 is an important institutional innovation in China, while many problems still need to be solved in the specific practice and application. This paper compared the practical development characteristics of the living will system between China and Japan, and analyzed the relationship between doctor-patients relationship under the intervention of the living will system and the symbolic representation mechanism of living will by using the semiotics theory. According to the links of "addresser-symbolic text" and "symbolic text-addressee", the six types of problems faced by current living will system in China were discussed, and the relevant experience and enlightenment were summarized to provided reference for the development of the living will system in China.

OBJECTIVE：To stu dy the effects of R&D expense additional deduction policy on R&D investment and profitability of pharmaceutical manufacturing industry ， and to provide reference for improving R&D investment and profitability of pharmaceutical manufacturing industry. METHODS ：Based on the data of Chinese pharmaceutical listed enterprises during 2012-2019，regression discontinuity design and descriptive method were adopted to analyze the effect of R&D expenses additional deduction policy on R&D investment and profitability of pharmaceutical manufacturing industry. RESULTS ：Both R&D investment and the main business profit margin had significant “jump”at the policy cutoff point ，and the policy effect coefficient of the R&D expenses additional deduction policy on R&D investment and profitability of the pharmaceutical manufacturing industry were 0.310 and －1.197 respectively（P＜0.001）. The policy effect coefficient of the policy on R&D investment in the eastern region was 0.413（P＜0.001），while the effect on central and western regions were not significant ；the policy effect coefficient of the policy on R&D investment of large-scale and small- and medium-scale pharmaceutical manufacturing industry were 0.502 and 0.264 respectively（P＜0.001）. CONCLUSIONS ：On the whole ，R&D expenses additional deduction policy has a positive incentive impact on R&D investment of pharmaceutical manufacturing industry ，but does not have a positive incentive impact on the profitability which is greatly affected by other factors. The policy has regional differences in the incentive impact on R&D investment of pharmaceutical manufacturing industry ；the incentive impact of the policy on the R&D investment of large-scale pharmaceutical manufacturing industry is better than that of small-and medium-scale one. It is recommended to improve the R&D expenses additional deduction policy ，reasonably increase the profit margin of the pharmaceutical manufacturing industry ，adjust the policy for different regions and focus on guiding policies to favor small- and medium-scale pharmaceutical manufacturing industry，so as to improve the R&D investment and profitability of pharmaceutical manufacturing industry.

OBJECTIVE：To evaluate the efficiency of drug safety supervision in Guangdong priovince and provide optimization suggestion for improving the construction of drug safety supervision system. METHODS ：Taking 21 cities in Guangdong province as samples ， the supervision input （supervision funds investment ， supervision and inspection of enterprises）-output（the rate of administrative penalty and qualified rate of sampling inspection ）data were collected from 2017 to 2018. Super-efficiency data envelopment analysis （DEA）model and Malmqusit index were used to analyze the efficiency of drug safety supervision from both static and dynamic point of view. RESULTS & CONCLUSIONS ：In static efficiency evaluation ， average drug safety supervision super-efficiency DEA in Guangdong province was 0.810，and the overall efficiency of drug safety supervision was in the low level ；among different cities ，there were obvious differences in supervision efficiency ；DEA values of only 5 cities（Shenzhen，Zhanjiang，Shaoguan，Qingyuan，Yangjiang）were higher than 1 and had achieved relatively effective results，while those of remaining cities were all invalid. In dynamic efficiency evaluation ，average Malmqusit index of drug safety supervision in Guangdong province was 0.787，which was decreased by 21.30％ in 2018 than 2017；the level of drug safety supervision in the whole province was declining ，and the main reason for the decline in the efficiency of drug safety supervision was technical backwardness ；technical efficiency played a promoter role in supervision efficiency to a certain extent. It is suggested that the efficiency improvement of drug safety supervision should further optimize resource allocation ，strengthen the level of supervision technical innovation ，expand the supervision scale ，and coordinate regional regulatory balance according to local conditions，so as to improve the construction of drug safety supervision system in Guangdong province.