In order to ensure the safety and efficacy of generic drugs for the substitution of narrow therapeutic index(NTI)drugs,and to improve and optimize China's generic drug substitution policy,we searched foreign literature databases and government websites to collect and sort out the typical measures taken by some foreign countries to ensure the safety and efficacy of generic drugs for the substitution of NTI drugs,including R&D registration,generic drug substitution and post-market surveillance.On the basis of comparative analysis,this paper summarizes the practices China can learn from.It can be seen that there are problems and challenges in China's generic drug substitution for NTI drugs,such as unclear targets for bioequivalence studies of NTI drugs,insufficient rational decision-making basis for generic substitution of NTI drugs,and imperfect post-market surveillance system,etc.It is recommended that we should formulate a list of NTI drugs,play the roles of physicians and pharmacists in generic drug substitution,adjust the generic drug substitution for NTI drugs according to the level of risk of drug use,and improve the reporting system for adverse reactions due to generic drug substitution.

OBJECTIVE To provide reference for the application of patient preference information in China by studying the application of patient preference information in the premarketing decision-making of medical products in the United States. METHODS The literature research method was used to explore the general situation， legal basis， and participants of the collection and application of patient preference information in the United States， analyze the application of patient preference information in premarketing decision-making of medical products in detail， and analyze the application status and challenges of patient preference information in China， so as to put forward suggestions. RESULTS & CONCLUSIONS United States has promoted the collection and application of patient preference information through several patient participation projects and legislation. The patient preference information is used to support premarketing decision-making of medical products： providing information for medical product development and design， and assisting clinical trial design in the research and development process； helping to support FDA’s marketing approval decisions， identifying patient groups whose benefits outweigh risks， and included in medical product descriptions in the marketing approval process. The application of patient preference information in China lacks the guidance of higher-level legal documents， and there are no targeted guidance documents. It is suggested that China should learn from the experience of the United States and clearly encourage the research and application of patient preference in higher-level legal documents； develop specific guidance documents for the collection and application of patient preference information； determine the weight and form of patient preference information to be considered in regulatory decision-making according to national conditions.

OBJECTIVE To provide reference for the construction of remote inspection mode of pharmaceutical production in China. METHODS By combing the guidance documents of remote inspection and related pilots issued abroad， the experience of constructing remote inspection mode of pharmaceutical production was summarized. RESULTS & CONCLUSIONS Typical foreign countries and regions have carried out remote inspection pilots all over the world， and clearly defined the application situation， implementation process， inspection techniques and related points for attention of remote inspection of pharmaceutical production. In terms of application， the European Union pointed out four specific applicable situations， including travel restrictions， while the United States stipulated that remote inspection was applicable to pre-approved inspection and so on. In terms of the implementation process， the United States developed a four-step method of remote inspection， while the European Union has defined the specific implementation process of remote inspection in more detail. In comparison， Japan paid more attention to the remote inspection process of production documents. In terms of inspection techniques， the European Union used 360° cameras， Matterport 3D technology and document review software to realize the remote inspection of production sites and production documents. In terms of attention points for remote inspection， the United States required that access rights should be set for information sharing to avoid information disclosure. Both the European Union and the United States required inspectors to be trained and equipment inspected before remote inspection. It is suggested that China should formulate unified guidelines for remote inspection of pharmaceutical production， clarify the applicable situations， and formulate the implementation process of remote inspection of pharmaceutical production with reference to the opinions of drug manufacturers. In addition， intelligent remote inspection technology can be used in combination with the information construction level of drug manufacturers， and remote inspection training program can be formulated to cultivate professional remote inspection team.

OBJECTIVE To sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML. METHODS The latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONS The common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.

OBJECTIVE To provide a reference for strengthening the post-admission management of drugs on the medicare formulary in China. METHODS The basic situation， implementation process and effect of post-market reviews （PMR） were introduced after marketing approval of the Australian pharmaceutical benefits scheme （PBS） subsidized medicines. The suggestions were put forward for post-admission management of medicare formulary drugs in China. RESULTS & CONCLUSIONS PMR system exemplified Australia’s concept of life-cycle management of medicines on the PBS catalogue； as a mechanism for managing the admission and adjustment of PBS medicines， it provided a continuous evaluation of medicines in the PBS catalogue； the process mainly included two types： the pre-initiation process of PBS drug review and the PBS drug review process， involving steps such as drug selection， determination of review scope， and implementation management. Through PMR， Australia had completed the review of multiple medicines in nine treatment areas including diabetes， childhood asthma and Alzheimer’s disease in the PBS catalogue. The author suggests that China can improve the post-admission review of medicines at the institutional level （clarifying the selection criteria and methods of the review object， main procedures and responsible parties， and ensuring the transparency of the review process）； specify the National Healthcare Security Administration or the third-party organization until a special technical organization is established to take charge of this work； at the same time， further improve the construction of data collection and monitoring systems.

In order to further consolidate the national essential medicine system and establish and improve the selection and adjustment mechanism of the national essential medicine list ，the Department of Drug Policy and Essential Medicine of the National Health Commission of the People ’s Republic of China recently has issued the Measures for the Administration of the National Essential Medicine List （Revised Draft ）. Under the background that China is in a critical period of improving the management procedures for the adjustment of the essential medicines list ，how to better design the adjustment procedure ，clarify the operation process and material requirements of each link ，ensure social participation and improve work transparency are important problems to be solved. By consulting the official websites of World Health Organization （WHO）and some typical countries with essential medicine system as well as related foreign literature ，the advanced practices of WHO and some typical countries in the adjustment procedures of the essential medicine list were summarized from 6 stages，such as start-up stage ，the material collection and summary stage ，the evaluation stage ，result publicity stage ，relief stage and application and promotion stage. It is suggested that China can learn from the relevant successful international experience ，scientifically set the adjustment cycle ，establish a normalized feedback mechanism with multi-agent participation ，design a standardized material collection process and a scientific and efficient evaluation process ，and improve the transparency and social identity of the publicity of the selection results of essential medicines ， so as to build a more scientific and perfect adjustment procedure of essential medicine list.

OBJECTIVE To explore the implementation strategy of China ’s drug patent linkage system from the perspective of the system design ，in order to encourage drug innovation and improve the development level of high -quality generic drugs . METHODS The current progress and challenges were summarized from the current situation of the implementation of China ’s drug patent linkage system by sorting out the relevant policy documents of the system . On this basis ，the successful experience and lessons of foreign countries were summarized to provide strategic suggestions for the implementation of China ’s drug patent linkage system in combination with China ’s basic national conditions . RESULTS& CONCLUSIONS With the introduction of the revised Patent Law of the People ’s Republic of China in 2020，China had basically completed the top -level design of the system ，but some rules and regulations had not been improved . There were still some problems ，such as the lack of a “fake infringement ”system in China，the lack of review and correction mechanisms for patent information registration ，poor links between judicial and administrative channels ，the dispute over the length of waiting period ，and the lack of clarity of relevant rules for the exclusivity period system of the first generic drug market . It is recommended that China establish a “fake infringement ”system and a judicial decision procedure for patent invalidation ，adjust the length of the waiting period or the basis for market approval ，further clarify the definition of the first generic drug ，the circumstances of jointly challenging patents and the reasons for the elimination of the market exclusivity period ，and strengthen the functional link procedures of relevant departments and implement the responsibility mechanism.

OBJECTIVE：To pro vide reference f or resolving structural imbalance of “supply and demand dislocation ”in each stage of new drug R&D funds in China. METHODS ：Through analyzing the fund demand in each stage of new drug R&D and the problem of “supply and demand dislocation ”in detail ，a financing scheme matching the fund demand of each stage was designed ， and analyzed with the financing process of “Wanke”. RESULTS & CONCLUSIONS ：In the basic stage of new drug R&D ，there was a large demand for funds ，but there were great technical risks ，transformation risks and investment risks ，little attention and support from investors ，resulting in the lack of R&D funds in this stage. It is suggested to increase the investment of R&D enterprises themselves. In the stage of new drug discovery ，the risks of R&D and investment were still high ，more funds were needed and funds were in short supply. It is suggested to attract more venture capital into this stage. From preclinical stage to clinical stage Ⅱ，there was a greater demand for funds. It is suggested that this stage should mainly rely on venture capital and pledge financing with patents. From the clinical stage Ⅲ to pre-marketing ，R&D had entered the mature stage with less investment risk. Therefore ，more venture capital could be obtained in this stage ，and there was a situation of excess capital. At this time ，in addition to venture capital ，R&D enterprises can also choose listing financing. In the post-marketing stage ，the sales right of a certain region in the product sales link could be transferred to provide new reserve funds for the next round of new drug R&D ，so as to achieve a virtuous circle of R&D activities. One of the reasons for the success of “Wanke”R&D financing lied in the combination of various financing methods in the financing process. It is suggested that China should improve the financial financing system and patent value evaluation system at the national level ，so as to promote the drug patent pledge financing in China as soon as possible. Finally ，new drug R&D institute must establish the concept of independent innovation ，speed up the output of technological innovation results ，so as to achieve the improvement of China ’s independent R&D capability.

OBJECTIVE：To analyze the application of health technology as sessment（HTA）for the selection of essential medicine in Thailand ，and to provide reference for optimizing the selection system of essential medicine in China. METHODS ：By retrieving related literatures and official websites ，the situation （selection mode ，institution and HTA institution ），process（main selection process of selection for essential medcine ，HTA process ） and supporting measures （HTA guideline ，HTA research database，standard cost list ）in the selection of essential medicine in Thailand were analyzed comprehensively. Suggestions to essential medicine selection in China were put forward. RESULTS & CONCLUSIONS ：The current selection model of essential medicines in Thailand is based on the application of stakeholders （pharmaceutical manufacturers ，healthcare providers ，patients or patient organizations ，etc.）through expert selection combined with HTA ，which is charged by essential medicine list subcommittee. The Health Intervention and Technology Assessment Program Center of its health economics working group is responsible for the specific work of essential medicine HTA. Its main process include the submission of applications by pharmaceutical manufacturers ， screening by essential medicine list committee ，expert selection ，and the coordination working group of essential medicine list to form the proposed list ，which is then examined and approved by the subcommittee ，minister of Health and National Drug System Development Committee ；finally the list was released. The high-price but necessary drugs are selected by the subcommittee and then the priority is assessed by the health economics working group. Non-profit organization or other interested organizations conduct HTA ；health economics working group and external audit experts evaluate the research quality ，and the health economics working group forms policy recommendations ； NLEMcommittee will carry out list access or price negotiation which then were considered by the subcommittee. In HTA supporting measures of Thailand ， HTA guidelines include HTA methodology guidelines （ensuring high quality economic evaluation and prom oting standardization of research fr amework）and HTA process guidelines （HTA is strictly regulated from transparency，accountability，inclusiveness，timeliness，quality，consistency，competitiveness）. HTA database include 4 kinds of economic evaluation researches （cost minimization analysis ，cost-benefit analysis ，cost-effectiveness analysis and cost-utility analysis），result evaluation ，quantitative research of life quality ，which supplied reference for research staff. The standard cost list makes the economical evaluation process more accurate and convenient. The selection of essential medicine in China can refer to the relevant experience of Thailand ，gradually establish health technology assessment system ，strengthen international cooperation and personnel training ；introduce the concept of priority ，and reasonably allocate evaluation resources ；formulate HTA guidelines ， improve supporting measures ；emphasize the participation of stakeholders to ensure the standard and transparent selection process ， so as to continuously improve corresponding selection system in China from aspects of the system construction ，resource allocation，supporting measures ，program optimization ，etc.

OBJECTIVE：To provide reference for deepening the reform of medical insurance payment mode in China. METHODS：By analyzing the specific reform process and driving factors of American Medicare ，and considering the background of current payment reform in China ，then some suggestions were put forward to promote the reform of medical insurance payment mode in China. RESULTS & CONCLUSIONS ：The payment mode of Medicare in the United States had undergone three stages ， which were post-payment system ，pre-payment system and value-based payment system. The payment modes included payment by service items ，payment by disease diagnosis related groups （DRGs）and payment by service value. The change was the result of the comprehensive effect of the three systems of technology ，politics and social culture in the United States. The demand for reasonable treatment and control fees drove the change from post-payment system to pre-payment system ，while the crisis of service quality ， the rise of service cost and the contradiction between doctors and patients drove the change to value-based payment. Payment mode reform had a positive impact on Medicare in the United States ，reducing medical expenditure and improving the quality of service. It is suggested that China should draw lessons from the experience of the United States in reforming the prepayment system nationwide on the basis of the current DRGs pilot projects. Meanwhile ，in order to avoid the medical quality crisis in the later period of the United States ，it is necessary to introduce the concept of value-based payment ，establish incentive and restraint mechanisms and strengthen the construction of the regulatory supporting system for the whole process.