The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Objective To systematically analyze the characteristics of the disease burden of hypertensive heart disease (HHD) in the elderly (≥60 years) globally and in China from 1990 to 2021, and to predict its future trends from 2022 to 2040, with the aim of providing data support for optimizing comprehensive prevention and control strategies for HHD. Methods Based on the Global Burden of Disease (GBD) 2021 database, the number of prevalent cases and disability-adjusted life years (DALYs) of HHD in the elderly were extracted for the world, China, and five regions categorized by sociodemographic index (SDI). Joinpoint regression was used to analyze the temporal trends of age-standardized prevalence rate and age-standardized DALYs rate of HHD in the elderly. A three-factor decomposition method was applied to evaluate the relative contributions of aging, population growth, and epidemiological changes to the variations in the elderly HHD burden. Additionally, a Bayesian age-period-cohort model was used to predict the elderly HHD burden from 2022 to 2040. Results In 2021, the number of prevalent elderly HHD cases reached 10 283 000 globally and 3 412 400 in China, representing increases of 179.20% and 159.20% respectively, compared with 1990. The DALYs of elderly HHD were 18 812 700 person-years globally and 4 731 400 person-years in China, rising by 76.08% and 29.45% respectively from 1990. Meanwhile, the growth rates of the number of prevalent cases and DALYs of elderly HHD varied across different SDI regions. From 1990 to 2021, the age-standardized prevalence rate of elderly HHD in China, as well as the age-standardized DALYs rate of elderly HHD both globally and in China, showed significant downward trends (all average annual percentage changes<0, all P<0.001). In 2021, the 70-74 years age group accounted for the highest proportion of prevalent cases and DALYs of elderly HHD, both globally and in China. Decomposition analysis revealed that population growth was the dominant factor driving the increase in the elderly HHD burden across all regions. The prediction model results indicated that the number of prevalent cases and DALYs of elderly HHD would continue to rise globally and in China from 2022 to 2040, with the growth rate of the elderly HHD burden in China between 2021 and 2040 expected to exceed the global average. Conclusion Over the past 32 years, although the age-standardized disease rates of elderly HHD have mainly shown a downward trend globally and in China, the absolute number of the disease burden has increased substantially. The projection model indicates a continued upward trajectory, with the growth rate in China higher than the global average. Therefore, there is an urgent need to implement precise prevention and control strategies to effectively mitigate the disease burden of elderly HHD.

The field of post-marketing benefit-risk assessment for traditional Chinese medicine（TCM） is still in its nascent stage， lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM， and explored the critical techniques and specific implementation steps involved in the assessment process. Initially， appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently， key technologies were outlined， including the establishment of a benefit-risk indicator system， the assignment of indicator weights， and the definition of criteria attributes. Furthermore， the implementation steps were elaborated， which involved defining decision-making issues， data collection， evaluation methodologies， variability factors， and sensitivity analysis. Finally， a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM.

Objective:Using primary care chronic disease management as a case,it aims to explore an economic incentive model for integrated primary healthcare services based on value pricing.Additionally,practical needs and implementation recommendations are proposed.Methods:With the help of the health technology assessment framework,it proposes that integrated health services can be priced through service effectiveness and service utility,and develops an economic incentive model with value pricing at its core based on the patient-centered incentive model for innovative healthcare services,including financing,payment,appraisal,and distribution,and puts forward feasible suggestions in the light of the needs and actuality of primary integrated services in China.Conclusion and Recommendation:The value-based pricing model for integrated health services serves as a theoretical foundation for the transformation of primary healthcare service functions and the enhancement of service dynamics,aligning with China's value-oriented service procurement strategy.This research contributes to the academic discourse by providing localized insights and a scholarly tone,contributing to the advancement of knowledge in the field.

Objective:To explore the difficulties and methods of value-based pricing of healthcare services,and to provide references for the price management of healthcare services in China.Methods:Based on the analysis of literature and policy,the operational methods of value-based pricing are clarified,and the international application experience of value-based pricing is reviewed.Comprehensive field research and interviews are conducted to analyze the difficulties in applying value-based pricing to healthcare services.Results:Currently,there are no mature theories and methods for value-based pricing of healthcare services,and there are also many practical difficulties in financing,payment,assessment and evaluation policies.Conclusion:In the future,it should consider incorporating service experience into the value framework independently of utility,and take"service utility"as the basis for pricing healthcare services,and select relevant indicators for measurement.At the same time,the price of healthcare services should take into account the willingness to pay of multiple parties,and stakeholders need to work closely together to form a consensus on value.

Objective:Compared to pricing based on input value,pricing based on output can better motivate service outcomes towards expectations and enhance input-output efficiency.The path of outcome value-oriented pricing for healthcare services is explored to provide a theoretical foundation for the value-based pricing of healthcare services.Methods:The concepts,methods and international experience of value pricing are sorted out.Results:Outcome-based pricing in healthcare services is divided into effect and utility,and is classified into four categories based on the different emphasis on the effect and utility of healthcare services.Conclusion:Services with a strong emphasis on effectiveness can draw inspiration from the Quantified Quality of Life(QALY)results in the medical technology field,while services with a strong emphasis on utility may require the development of new utility scales for service evaluation.

Objective:Using primary care chronic disease management as a case,it aims to explore an economic incentive model for integrated primary healthcare services based on value pricing.Additionally,practical needs and implementation recommendations are proposed.Methods:With the help of the health technology assessment framework,it proposes that integrated health services can be priced through service effectiveness and service utility,and develops an economic incentive model with value pricing at its core based on the patient-centered incentive model for innovative healthcare services,including financing,payment,appraisal,and distribution,and puts forward feasible suggestions in the light of the needs and actuality of primary integrated services in China.Conclusion and Recommendation:The value-based pricing model for integrated health services serves as a theoretical foundation for the transformation of primary healthcare service functions and the enhancement of service dynamics,aligning with China's value-oriented service procurement strategy.This research contributes to the academic discourse by providing localized insights and a scholarly tone,contributing to the advancement of knowledge in the field.

Objective:To explore the difficulties and methods of value-based pricing of healthcare services,and to provide references for the price management of healthcare services in China.Methods:Based on the analysis of literature and policy,the operational methods of value-based pricing are clarified,and the international application experience of value-based pricing is reviewed.Comprehensive field research and interviews are conducted to analyze the difficulties in applying value-based pricing to healthcare services.Results:Currently,there are no mature theories and methods for value-based pricing of healthcare services,and there are also many practical difficulties in financing,payment,assessment and evaluation policies.Conclusion:In the future,it should consider incorporating service experience into the value framework independently of utility,and take"service utility"as the basis for pricing healthcare services,and select relevant indicators for measurement.At the same time,the price of healthcare services should take into account the willingness to pay of multiple parties,and stakeholders need to work closely together to form a consensus on value.

Objective:Compared to pricing based on input value,pricing based on output can better motivate service outcomes towards expectations and enhance input-output efficiency.The path of outcome value-oriented pricing for healthcare services is explored to provide a theoretical foundation for the value-based pricing of healthcare services.Methods:The concepts,methods and international experience of value pricing are sorted out.Results:Outcome-based pricing in healthcare services is divided into effect and utility,and is classified into four categories based on the different emphasis on the effect and utility of healthcare services.Conclusion:Services with a strong emphasis on effectiveness can draw inspiration from the Quantified Quality of Life(QALY)results in the medical technology field,while services with a strong emphasis on utility may require the development of new utility scales for service evaluation.

Objective:Using primary care chronic disease management as a case,it aims to explore an economic incentive model for integrated primary healthcare services based on value pricing.Additionally,practical needs and implementation recommendations are proposed.Methods:With the help of the health technology assessment framework,it proposes that integrated health services can be priced through service effectiveness and service utility,and develops an economic incentive model with value pricing at its core based on the patient-centered incentive model for innovative healthcare services,including financing,payment,appraisal,and distribution,and puts forward feasible suggestions in the light of the needs and actuality of primary integrated services in China.Conclusion and Recommendation:The value-based pricing model for integrated health services serves as a theoretical foundation for the transformation of primary healthcare service functions and the enhancement of service dynamics,aligning with China's value-oriented service procurement strategy.This research contributes to the academic discourse by providing localized insights and a scholarly tone,contributing to the advancement of knowledge in the field.