To provide auxiliary decision-making support to improve incentive policies for pediatric drug development and approval, we systematically review the current status of research on and approval of anti-epileptic drugs (AEDs) for children at home and abroad, and comprehensively analyze the existing barriers in China’s pediatric AED development and market approval process. Findings reveal that China lags behind some countries and regions included in this comparative study (United State of America, European Union, Japan and Australia, etc.) in terms of research and development (R&D) capability and progress in pediatric AEDs, with significant disparity in the diversity of approved drugs, formulations, and dosage forms. It is recommended that China enhance its policy support for R&D, optimize the drug evaluation and approval system, strengthen the management of drug allocation and utilization, promote rational drug use, reinforce post-marketing incentive policies and help foster a more favorable policy environment for the development and approval of pediatric medications.

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 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.

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.

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 provide referen ce for improving commission management system of medical insurance in China. METHODS：By analyzing the problems of commission management system of medical insurance in China ，studying the specific types，responsibility division and its features of basic medical insurance contractors in the United States ，the suggestions were put forward for improving corresponding system in China. RESULTS & CONCLUSIONS ：There are some problems in the entrusted management of medical insurance in China ，including that the fair competition mechanism has not been established ；the operation and management of social security fund lacks of supervision mechanism ；the role of the government is unclear and inexperienced ； the imperfect supervision mechanism causes follow-up problems ；it is still uncertain whether the entrusted management system can improve the efficency of medical insurance management. In the United States ，the way of entrusted management of medical insurance was to introduce the third-party management. The contractors employed by the Centers for Medicare and Medicaid Services in the United States mainly included medical insurance contractor ，zone program integrity contractor ，comprehensive error rate test review contractor and statistical contractor ，supplemental medical review contractor ，qualified independent contractor and so on ，among which medical insurance contractor was in the core position. Each contractor had a clear division of labor in handling medical claims ，preventing medical fraud ，reviewing the correctness of payments ，evaluating medical records and handling appeals. This mode greatly reduced the work pressure of the government ，improved the efficiency of medical insurance management and operation，and promoted the continuous improvement of the whole system. It is suggested that China should expand the scope of social agency management ，clarify the responsibilities of government and social resources ，introduce various types of social economic organizations and establish a complete and effective performance supervision and management system in order to improve the modernization level of China ’s medical insurance governance.

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.