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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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OBJECTIVE：To provide reference for further standardizing and improving the selection of essential medicine in China. METHODS ：The selection mode of essential medicine in South Africa was introduced ，involving organizational structure and responsibilities ，selection criteria ，selection procedure ，dynamic adjustment mechanism and implementation effect. The suggestions were put forward for improving selection mode of essential medicine in China. RESULTS & CONCLUSIONS ： Pharmaceutical and Therapeutics Committees at all levels in South Africa were responsible for collecting applications for essential medicine and submitting them to the Rational Selection Group for preliminary screening ，which was finally decided by the National Essential Drugs List Committee ；the selection criteria was mainly based on WHO essential medicine selection criteria ；the selection basis of essential medicine in South Africa was based on standard treatment guidelines ；a bottom-up normalized user feedback mechanism was established to dynamically adjust the list ，and more attention was paid to drug evidence and evidence level in the review process ；the review points tended to focus on evidence and the level of evidence. In general ，the selection of essential medicines in South Africa had high recognition and good application. It is recommended that China appropriately refer to the practice of South Africa ，take clinical guideline as one of the selection criteria ，establish daily gradual feedback channels ， strengthen the review of evidence ，unify Chinese evidence grading system ，and combine Chinese national conditions to finally explore a selection model for essential medicine with Chinese characteristics.
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OBJECTIVE： To provide reference for the establishment and improvement of drug reevaluation system in China. METHODS： The design and relevant laws of drug reevaluation system in America， European Union and Japan were reviewed and summarized. The shortcomings of drug evaluation in China were analyzed and suggestions for improvement were put forward. RESULTS & CONCLUSIONS： America， European Union and Japan have formulated relevant laws and systems for post-marketing reappraisal of drugs， as well as specific implementation norms and technical support plans. The legal system of drug reevaluation in America can be divided into ADR monitoring and reporting system， post-marketing drug research system and active drug safety risk monitoring system. The European Union mainly has a monitoring and evaluation system for conventionally marketed drugs， drugs licensed under exceptional circumstances or conditions， and a re-registration system for drugs. Japan’s legal system of reevaluation mainly consists of reexamination system， reevaluation system and other systems. However， there are still some shortcomings in the drug reevaluation in our country， such as weak system， weak legislation， inadequate operability and deterrence， ineffective links between the implementation and application of drug evaluation results， and ineffective allocation of resources. It is suggested that we should integrate the existing reevaluation system to improve the legal system of drug reevaluation in China，starting from the systematic construction of the legal system of drug reevaluation， the construction and standardization of the legislative level， the connection of the legal system of drug reevaluation and the allocation of resources.
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OBJECTIVE： To provide reference for the establishment and improvement of the post-marketing re-evaluation of drugs （shorted for re-evaluation） legal system in China. METHODS： Through sorting out American re-evaluation system， this paper focused on the current situation and procedures of the implementation of American re-evaluation system and put forward the suggestions for improving drug re-evaluation system in China. RESULTS & CONCLUSIONS： American re-evaluation system takes enterprises as the main body of execution and the government as the main body of supervision. It has the characteristics of highly informatized and transparent process. The work includes the report of ADR implementation of monitoring systems， the periodic reporting system and the post-listing clinical trials and research systems. The implementation process is to find clues， FDA preliminary review and notification， enterprise further self-examination and review， corporate actions and accept FDA supervision. It is suggested that when establishing the legal system of re-evaluation system in China， the main role of patients should be highlighted， and risk communication should be guided by the public. For example， the Medwatch voluntary reporting system of FDA can be imitated. The unified data collection， storage system and scientific data processing methods can be established. Continuously strengthen the main responsibility consciousness of pharmaceutical enterprises in testing and reporting， and constantly reduce the risk of drug use of patients.
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OBJECTIVE： To provide reference for the improvement of OTC drug management system in mainland China. METHODS： By analyzing the classification， registration management， conversion procedures and supporting measures， instructions and packaging management of OTC drugs in Taiwan area of China， and considering the current situation and problems of OTC drug management in mainland China， suggestions for improving OTC drug management system in mainland China were put forward. RESULTS & CONCLUSIONS： OTC drugs of Taiwan area could be divided into drugs instructed by physicians and pharmacists （hereinafter referred to as “instructed drugs”） as well as patent drugs. The registration management of instructed drugs was implemented in accordance with the Criteria for the Review of Instructed Drugs. The criteria not only regulated the active ingredients， dosage forms， indications， usage and dosage， side effects， matters needing attention and warnings of instructed drugs， but also stipulated the requirements for labeling， instructions and outer-of-the-box printing of instructed drugs. Taiwan area had also established a mechanism for evaluating drug conversion to expand the variety range of prescription drugs converted to OTC drugs， and had equipped a series of supporting measures to reduce the safety risks arising from drug conversion. In 2016， Taiwan area also formulated the Format and Relevant Standards for Outer-of-the-Box of Generic Western OCT Drug， and revised the drug instructions and the outer-of-the-box. The format was more standardized and the terminology was easier to understand， which made it easier for the public to read. It is suggested that mainland China should refer to the experience of Taiwan area， set up special registration channels for OTC drugs and simplify the requirements for examination and approval， pay attention to and improve the matching measures for the conversion of prescription drugs to OTC drugs， encourage brand building and improve intelligibility of OTC drug instructions， so as to build an effective OTC drug management system.
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OBJECTIVE:To introduce high-value drug insurance access mechanism in Australia,and to provide suggestion for improving orphan drug medical insurance access in China. METHODS:By literature study and policy analysis,access principle, risk-sharing mechanism and restricted use principle of high-value drug insurance access in Australia were summarized and analyzed, so as to evaluate the effects of high-value drug insurance access mechanism. RESULTS & CONCLUSIONS:The inclusion of high-value drug in Australian National Formulary considers not only the cost-effectiveness ratio,but also the drug’s clinical effica-cy,irreplaceability and the social principles;risk-sharing mechanism and restricted use principle achieve a good balance between the accessibility of patient’s medication and the sustainability of health insurance fund;remarkable results are achieved in guarantee-ing patient’s medication and strengthening basic medical insurance. It is recommended to perfect orphan drugs medical insurance ac-cess standard,introduce risk-sharing mechanism and standardize the use of orphan drugs and reimbursement in China.
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@#This paper explores the relevance between data protection system and drug availability through the American lamotrigine(lamictal® )case. Results indicated that drug data protection system delays the marketing of genetics, hinders the pricing regulation of innovative drugs timely and effectively, and affects drug availability severely. With reference to America, it is urgent to design the scope of data protection system reasonably, and set the first generic drug regime and other supporting measures so as to reduce the negative effects of drug data protection system and improve the health benefits of the public.
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OBJECTIVE: To provide proposal for government on dealing with the relationship between commercial and social property of drugs.METHODS: Multi-stakeholders subjects and their interrelation in the listing decision of drugs were investigated using game model.RESULTS & CONCLUSIONS: Innovation level of pharmaceutical industry (P),profitability of drugs operator (E),other factors affecting the proceeds of drug operators (K),additional gold cost of drugs (C1),additional cost of gold drugs sale (C2) were confirmed to be the key factors which affected the listing decision of drugs by pharmaceutical manufacturers.Governments are suggested to ensure the rational and fair use of drugs in public by policy supports,encouraging drug innovation and make-up on difference of drugs in medical institutions,optimizing benefit components of medical institutions,creating evaluation criteria for "listing value" and "necessity in clinic" of drugs.