亚洲社会药学

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1. Strategic Planning for Drug Regulatory Science in the United States and Its Enlightenments to China

Chang Yingnan, Gong Jingran, Chang Senhao, Chen Yuwen

亚洲社会药学 2023, 18 (2): 91-97.

摘要（487）

PDF（pc）（805KB）（241）

Objective To study the strategic planning of drug regulatory science, the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strategic planning of drug regulatory science in China. Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States. Results and Conclusion Drawing on the US experience, China should set goals based on mission and vision and identify problems, knowledge gaps, and key areas, then concrete measures can be taken to advance regulatory science.

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2. Research on the Regulatory Framework of Advanced Therapies in the European Union and the United States

Wulan Qiqige, Yang Yue, Huang Zhe

亚洲社会药学 2023, 18 (2): 98-106.

摘要（434）

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Objective To study the regulatory framework of advanced therapies in the European Union and the United States, and to provide reference for the regulation of cell- and gene-based therapeutic products in China. Methods The legal and regulatory documents, annual reports, work information and related literature published on the websites of the FDA and European Medicines Agency (EMA) were reviewed to analyze the regulatory models of advanced therapies in the European Union and the United States. Results and Conclusion the United States and the European Union have carried out a lot of work in the classification standards of advanced therapies, policy formulation and accelerated listing procedures. Therefore, they have established a relatively mature regulatory system. China can learn from their experience and continuously improve the regulatory system to help the sustainable development of gene and cell therapy industry.

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3. Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces

Cui Yihang, Chen Binbin, Sun Lihua

亚洲社会药学 2023, 18 (2): 107-115.

摘要（433）

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Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces. Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021, combined with the current provisions and implementation of drug spot check management in China. Results and Conclusion At present, there are some problems in the drug spot check of Chinese herbal pieces, such as fewer varieties of Chinese herbal pieces in the national drug spot check, the unreasonable sampling links, the insufficient territorial management in some areas, and error-prone sample extraction. It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan. Besides, the variety coverage of drug spot check of traditional Chinese medicine should be strengthened. In the planning, the sampling links shall be made as a whole, and the credit rating and distribution of drug production, operation and use units within the jurisdiction shall be fully combined. While strengthening the sampling management at the production end in areas with concentrated industries, regional special drug spot check should be carried out or the administrative forces at the provincial, municipal and county levels should be fully mobilized to avoid local protection. In the assigned tasks, the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods.

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4. Study on the Management of Chronic Diseases in American and British Community Pharmacy

Chen Qianqian, Tian Lijuan

亚洲社会药学 2023, 18 (2): 157-164.

摘要（408）

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Objective To provide a reference for promoting the construction of chronic disease management in community pharmacies in China. Methods Literature research and comparative research methods were used to analyze the management of chronic disease carried out by community pharmacies in the United States and the United Kingdom. Results and Conclusion The management of chronic diseases in American and British community pharmacies has formed retail health clinic and online chronic disease mode. It is recommended that Chinese government should issue measures and supporting guidelines for the management of chronic diseases in community pharmacies as soon as possible. Community pharmacies should be encouraged to carry out chronic disease management with the concept of prudent inclusion and gradual progression. Meanwhile, the concentration of drug retail industry should be improved to carry out the systematic construction of chronic disease management and build a standardized chronic disease service process. Besides, community pharmacies should make full use of new technologies such as the Internet, cloud computing and big data, smart wearable devices, and chronic disease management Apps to explore and carry out online professional chronic disease management mode.

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5. Present Situation and Thinking of the Evaluation and Management of Biomedical Projects in Shenzhen Industrial Park of Shenzhen-Hong Kong Cooperation Zone

Zhao Xuanhe, Wang Shuling

亚洲社会药学 2023, 18 (2): 116-127.

摘要（360）

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Objective To put forward some suggestions for the improvement of the evaluation system of Shenzhen Industrial Park of Shenzhen-Hong Kong Innovation Cooperation Zone by studying the scientific research project evaluation and management system of Japan Agency for Medical Research and Development (AMED). Methods Through literature review, lessons were drawn from the review and management policies and methods of biomedical projects implemented by Japan AMED. Then some reference was provided to the review and management of the projects in Shenzhen Industrial Park. Results and Conclusion A basic review framework has been set up in Shenzhen Industrial Park, which consists of scientific research management institution of Shenzhen Industrial Park, Third-Party Review Institution and Science Committee. However, there are three problems in this system: unclear selection criteria of review experts, insufficient supervision and lack of project evaluation standards. These problems can be solved by establishing an expert think tank, setting up graded project supervisors to have the dynamic monitoring, and developing a general evaluation scale for evaluating scientific research projects in Shenzhen Industrial Park.

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6. Enlightenment of COVID-19 Treated by Botanical Drugs on the Development of Drugs for Rare Diseases in China

Li Qiao, Wang Su, Wang Aili, Wu Di, Chen Yuwen

亚洲社会药学 2023, 18 (2): 137-148.

摘要（357）

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Objective To study the feasibility of developing botanical drugs to treat intractable diseases and play an important role in dealing with major public health crises. Methods From January 1990 to May 2021, a bibliographic search was carried out on the use of botanical drugs, rare disease drugs, related registration management policies and regulations in PubMed and CNKI. The following keywords were searched in the database: Rare disease policies and regulations, orphan drugs, botanical drugs for intractable diseases, botanical drugs for the treatment of new coronary pneumonia, traditional Chinese medicine, and emergency guidelines for major public health crisis. Other data were obtained from “Chinese Pharmacopoeia” and relevant Chinese government websites for sorting and analysis. Results and Conclusion Based on 39 Chinese corresponding policies and regulations, challenges and opportunities of developing and researching drugs for treating rare diseases were found out after the analysis and comparison. Based on the study of national policies on drugs for rare diseases, the priority review and approval procedures in the drug registration, as well as China’s emergency guidelines and policies for major public health events, some problems in the use of drugs for rare diseases are found out. Therefore, it is recommended to actively adopt the property rights protection system, explore the folk prescriptions of traditional Chinese medicine and the potential of hospital preparations, and the registration review strategy of giving priority to the use of botanical drugs for rare diseases. Thus, the international status of botanical drugs for rare disease and the influence of responding to major public health events can be enhanced.

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7. Investigation on the Current Situation of China’s DTP Pharmacy and Suggestions for Its Development

Wen Dong, Dou Lele, Sun Yuyuan, Wang Shuling

亚洲社会药学 2023, 18 (2): 165-176.

摘要（347）

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Objective To summarize the main characteristics and development approaches of direct-to-patient (DTP) pharmacies, and to explore its future development trend. Methods Firstly, relevant policies of DTP pharmacies were sorted out based on some documents on the government website, and related articles were studied. Secondly, 499 DTP pharmacies were investigated. Finally, the current status of the industry was summarized and analyzed. Results and Conclusion Policies on China’s DTP pharmacy have been constantly improved. According to industry standards, the current compliance rate of DTP pharmacies is about 46.09%. In terms of varieties, the market share concentration rate of biological products is higher than that of chemical drugs. The regional distribution of these drugs is mainly concentrated in the central and eastern provinces. However, 63.45% of DTP pharmacies have less than 50 product specifications. DTP pharmacies have an average of 7.3 pharmacy technicians and 2.3 licensed pharmacists, which is higher than that of ordinary pharmacies. Due to the policy promotion, DTP pharmacies will be paid more attention by the public and the government, and the market share will become larger than before. Patients shifting from hospitals to drug-to-pharmacies can make them better layout. Besides, pharmaceutical services will become more specialized, and disease division will be more detailed. With the deepening of medical reform and the continuous improvement of national medical security as well as drug procurement and medical insurance payment methods, DTP pharmacies can play an important role in the national basic medical security system.

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8. Research on Liposomal Irinotecan in Combination with 5-FU/LV for Metastatic Pancreatic Ductal Adenocarcinoma

Wang Wenjun, Wang Yaoling, Huang Zhe

亚洲社会药学 2023, 18 (2): 128-136.

摘要（346）

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Objective To systematically review the published clinical and economic research on liposomal irinotecan in combination with 5-FU/LV for metastatic pancreatic ductal adenocarcinoma (mPDAC) at home and abroad. Methods PubMed, Cochrane Library, Embase, CBM, CNKI, Wan Fang data, CRD database and health technology assessment official websites were searched to collect clinical and economic studies on liposomal irinotecan for mPDAC. Results and Conclusion Nine clinical studies and four economic studies were included. The result of clinical studies showed that liposomal irinotecan in combination with 5-FU/LV could extend survival with good drug compliance in patients with mPDAC who progressed on prior gemcitabine-based therapy. This agent represented a new treatment option for second-line chemotherapy in these patients. The results of the economic evaluations failed to reach a consistent conclusion due to different economic levels in various countries.

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9. Influence and Suggestions on Trial Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes

Li Wanying, Zhang Weiwei, Jia Siyao, Dong Li

亚洲社会药学 2023, 18 (2): 149-156.

摘要（340）

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Objective To study the core contents of the “Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (Trial)” in China, and to clarify the concerns for enterprises in future work. Methods A comprehensive review of the literature was used to find out the key regulations for detailed decomposition and analysis. Results and Conclusion By analyzing the key clauses of China’s “Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (Trial)”, some practical countermeasures and suggestions are put forward for related research and development (R&D) innovation and drug declaration of enterprises.

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10. Enlightenment and Suggestions on the Construction of Information Platform and Processing Mechanism of Drug Shortages in Developed Countries to China

Cui Li, Xing Hua

亚洲社会药学 2023, 18 (2): 177-186.

摘要（255）

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Objective To study how to improve and perfect the information platform and processing mechanism of drug shortages in China. Methods By searching the relevant policies from official websites of FDA, European Medicines Agency (EMA), Health Canada (HC) and National Health Commission, the good experience of the United States, the European Union and Canada in the construction of information platform and processing mechanism of drug shortages was summarized for reference in China. Results and Conclusion China has initially established the processing mechanism of drug shortages, but the platform construction should be improved, and the information disclosure of drug shortages varies from province to province. We should improve the information platform of drug shortages, strengthen the disclosure and communication of information, enrich the processing tools and measures after the drug shortages occurs, and strengthen the cooperation with relevant associations and other non-governmental departments.

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11.

Research Progress in FDA’s Focus Areas of Regulatory Science for Drugs and Suggestions for China

Gong Jingran, Chang Senhao, Chang Yingnan, Chen Yuwen

亚洲社会药学 2023, 18 (3): 191-197.

摘要（84）

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Objective To sort out the focus areas of FDA’s scientific supervision and to achieve corresponding results, so as to provide some suggestions for the scientific research and innovation of drug supervision in China. Methods In-depth research was carried out in the fields of safety evaluation tools, clinical trial innovation, new methods ofproduct quality evaluation, information science and so on. Results and Conclusion The research foundation of drug supervision related technology in China is weak, and a systematic supervision system has not been formed. Learning from the scientific experience of drug supervision in the United States, we can promote the development of the focus areas of drug supervision in China. Besides, we should improve the standard management ability while perfecting the regulations and standards system. Lastly, we should establish a system for government and industry-university-research to realize the full-cycle supervision of drugs.

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12.

Effect of the Policies to Prevent Drug Shortage and Stabilize Drug Prices in Medical Institutions

Li Xiaoqi, Fan Jianing, Huang Jiaxin, Liu Xinying, Raela·Abduhilil, Sun Lihua

亚洲社会药学 2023, 18 (3): 247-251.

摘要（68）

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Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices, and to provide reference for improving relevant policies. Methods With a combination of random stratified sampling and quota sampling, 532 medical institutions in 20 provinces were selected to carry out questionnaire surveys. Then, a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices. Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions, but it did not curb the growth of drugs on non-shortage list. Besides, the drugs on non-shortage list showed an overall fluctuation and upward trend. Meanwhile, from the perspective of drug prices, the price stability problem of drugs on the shortage list and on the non-shortage list became more serious, and the average price increase was 256% and 239%, respectively. The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions, which has been recognized by most medical institutions. However, there is an increasing trend in the number of drugs on non-shortage list. In addition, the price increase of drugs on both the shortage list and non-shortage list is severe. Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification, grading and the alternative use of drug shortages. It is recommended to strengthen the management of price stabilization of drugs on the shortage list. Further attention should be paid to the supply and price stabilization of drugs on non-shortage list. At the same time, trainings in the classification and substitution of drug shortage and information reporting system should be actively organized, thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage.

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13.

Cost-effectiveness Analysis of Insulin Degludec and Liraglutide Injection in the Treatment of Type 2 Diabetes

Sun Quan, Zhang Fang, Dong Li

亚洲社会药学 2023, 18 (3): 281-295.

摘要（62）

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Objective To analyze the cost-effectiveness of insulin degludec and liraglutide injection (IDegLira) compared with insulin glargine plus insulin aspart (IGar plus IAsp) in the treatment of type 2 diabetes mellitus (T2DM) based on the price of IDegLira before and after it was successfully admitted to the National Reimbursable Drug List (NRDL). Methods Cost and effectiveness parameters were obtained through systematic retrieval from PubMed, ScienceDirect, CNKI, and Wanfang database. A cost-effectiveness analysis (CEA) model was established to analyze the economics using IDegLira for T2DM patients with 1 to 5 years of medication. Results and Conclusion Before IDegLira was admitted to NRDL, its economic advantages over the IGlar plus Iasp regimen became more significant as patients’ medication time prolonged. After being admitted to NRDL, with 1 year of medication, the medical cost of IDegLira decreased by 2 853.91 yuan and the quality adjusted life years (QALY) increased by 0.120 55 than IGar plus IAsp. The sensitivity analysis was highly consistent with the results of the baseline result. After being admitted to NRDL, for patients with T2DM who have poor blood glucose control, IDegLira is absolutely an economic advantage scheme compared with IGar plus IAsp.

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14.

Hypersensitivity Reaction Caused by Intravenous Gadolinium-based MRI Contrast Agents

Lai Jing, Qin Liangyi, Qin Yane, Lan Xiaobu, Zhang Qi

亚洲社会药学 2023, 18 (3): 296-298.

摘要（60）

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Objective To present a rare case of skin allergic reaction to gadobutrol, a magnetic resonance imaging (MRI) contrast agent, in a 37-year-old man. Methods The adverse reactions of gadobutrol were analyzed combined with the instructions and related literatures. Results and Conclusion The presence of this patient is consistent with the adverse reactions in the instructions of gadobutrol. The incidence of ADR in gadobutrol is considered to be low, although sometimes patients report a hypersensitivity reaction when undergoing MRI. There are only a few cases of immediate adverse reactions to gadobutrol. However, we should improve the ability of medical staff to use drugs safely and take preventive measures.

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15.

Suggestions for Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme - PIC/S

Hu Shigao, Wu Zhiang

亚洲社会药学 2023, 18 (3): 206-212.

摘要（58）

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Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme (PIC/S) audit checklist, find out the key improvement items, and revise them pertinently, which will promote the process of China joining PIC/S. Methods The general situation of PIC/S organization and audit checklist were introduced first, and then the accession of several countries that joined the organization was analyzed. Meanwhile, the process of China’s participation in PIC/S was sorted out. After referring to the contents of PIC/S audit checklist, the problems of GMP inspection system in China were studied. Results and Conclusion There are still many problems in GMP inspection in China. Some suggestions are put forward for improvement and change, which can provide reference for the development of drug inspection agencies at all levels in China.

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16.

A Systematic Review of Patient-Reported Outcome Measurement for Psoriasis in Chinese Population

Li Kexin, Zhang Fang, Huang Zhe

亚洲社会药学 2023, 18 (3): 261-280.

摘要（57）

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Objective To review the development of patient-reported outcome measurement (PROM) for patients with psoriasis in China, and to analyze the main results and methodology. Methods The systematic review method of COSMIN (consensus-based standards for the selection of health measurement instruments) was adopted, and the domestic and foreign databases were searched to find the patient-reported outcome scales based on Chinese psoriasis patients. Then, the included studies were evaluated by using COSMIN risk of bias checklist. Results and Conclusion A total of 3 studies were included, involving 3 scales. We found that the quality evaluation of the development process of the 3 scales was not high, and there were large methodological loopholes in the whole cycle of scale development and verification. The included studies have many problems such as low extrapolation, poor quality, and lack of validation, which can provide more insights for the quality control requirements of the whole cycle of scale development in the future.

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17. Investigation and Countermeasures of the Development of Chinese Pharmaceutical E-commerce in the B2C Model Based on PEST-SWOT Analysis

Xiu Yu, Wang Shuling

亚洲社会药学 2023, 18 (4): 398-405.

摘要（57）

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Objective To analyze the problems of pharmaceutical e-commerce and provide strategies for its development in the future B2C mode since drug network management has great potential in China. Methods By collecting, identifying, and conducting literature research, PEST-SWOT identification and positioning of pharmaceutical e-commerce in the B2C mode were carried out. Results and Conclusion A PEST-SWOT analysis matrix was established to analyze the status of B2C pharmaceutical e-commerce, and to summarize its advantages, disadvantages, opportunities and threats from four perspectives of politics, economy, society and technology. Suggestions on cultivating compound talents proficient in medicine and e-commerce, exploring online payment methods for medical insurance, integration of upstream and downstream of the industrial chain and data sharing are put forward to promote the healthy and long-term development of pharmaceutical e-commerce under the background of big data.

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18. Research on Incentive Policies for Chinese Innovative Drug R&D - Taking Innovative Anti-tumor Drugs as an Example

Wang Yuejun, Yang Yue, Huang Zhe

亚洲社会药学 2023, 18 (4): 303-314.

摘要（56）

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Objective To provide reference for improving Chinese innovative drug research and development incentive policies. Methods Based on investigating the incentive policies for innovative drug research and development in clinical research, evaluation and approval in China, anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis. Results and Conclusion Driven by a series of incentive policies for innovative drug R&D, great achievements have been made on anti-tumor drugs. However, there are problems such as concentration of drug targets, homogenization of clinical trials, and gaps in some drugs with large clinical needs. To improve incentive policies for innovative drug R&D, China should adhere to the orientation of clinical value, focusing on basic research and translational research, improving evaluation and approval capabilities, and establishing a sound ecosystem for innovative drugs.

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19.

Exploration and Research on the Integrated Development of “Internet Plus Medical Treatment”

Guo Jialin, Wang Shuling

亚洲社会药学 2023, 18 (3): 252-260.

摘要（56）

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Objective To analyze the development of “internet plus medical treatment” and to explore advantages. Methods The literature of “internet plus medical treatment” was systematically combed and analyzed. Results and Conclusion After exploring the status quo of “internet plus hospitals”, smart pharmacy and web-assisted health management in China, we find that there are some problems in the medical service at present, such as the imperfect laws and regulations, the hidden dangers of information security and the obstacles of medical insurance payment. Therefore, we propose that the development of web-assisted medical service should be led by the government and relevant policies must be improved. Then, self-regulation should be strengthened, and industry standards should be enhanced. Three suggestions are made to improve medical insurance payment and benefit both hospitals and patients, which can provide reference for promoting the development of “internet plus medical treatment” in China.

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20. Current Situation and Prospect of the Application of Real-World Evidence in Health Care

Xiao Feiyi, Zhang Fang, Li Xue, Dong Li

亚洲社会药学 2023, 18 (4): 374-386.

摘要（56）

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Objective To summarize the application of real-world evidence (RWE) in the medical and healthcare field of various countries, including relevant policies, application scenarios and application methods. Methods Relevant policies and application scenarios were obtained by consulting the official websites and public documents of various countries’ healthcare institutions. Systematic literature retrieval was adopted to search PubMed, EMBASE, Cochrane Library, CNKI, CBM and Wanfang databases, and all papers related to real-world study and application were included. Then, these papers were classified and analyzed by country and application method. Results and Conclusion The RWE was mainly applied to supporting the preliminary approval of a new drug, expanding drug indications, accelerating approval or supporting conditional marketing authorizations and drug safety evaluation, etc. The United Kingdom, the United States, Germany, the Netherlands, Italy, Sweden, and France admitted RWE, but they treated the data obtained from RWE with caution. After systematic literature retrieval, a total of 701 articles were obtained, including relevant studies from 36 countries, among which the United States published 264 in total. The most common study was about using real-world data (RWD) to calculate treatment-related costs, which had a total of 259 studies. Secondly, 158 articles were used for epidemiological analysis. Then, 138 articles were about establishing risk models to analyze disease risk factors. A total of 70 articles were real-world efficacy evaluation of the drug treatment schemes, 54 articles were about pharmacoeconomic evaluation with RWD as parameters. A total of 29 articles used RWD to build predictive models, and 15 articles used RWD to evaluate the health-related quality of life in patients. The application of RWE has been used widely in the medical and healthcare field of various countries. The application scenarios are gradually diversified, the application methods of RWD become mature, and the evidence quality of RWE is also improved greatly.

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21.

An Empirical Study on Organizational Efficiency of Drug Review Institutions

Wu Dongming, Jia Zheng, Wang Lifei, Xing Hua

亚洲社会药学 2023, 18 (3): 221-231.

摘要（52）

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Objective To construct the influencing factor model of organizational efficiency by using structural equation model, and to put forward some suggestions for drug review institutions to their management mode. Methods The model hypothesis affecting organizational efficiency was proposed by literature analysis, and a questionnaire was designed. Then, the questionnaires returned were analyzed to investigate the relationship among the factors affecting organizational efficiency with the structural equation models. Results and Conclusion The direct effect of communication on organizational efficiency was 0.83, that of system construction was 0.60, talents cultivation was 0.25, and task management was 0.38. The model results basically fitting met the various statistical indicators, with statistical significance thresholds. Talents cultivation and task management have little effect on organizational efficiency, while system construction and communication have great effect on organizational efficiency. However, due to the correlation between organizational systems, the influencing factors should be considered in a balanced manner, so as to put forward reasonable suggestions.

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22.

The Impact of Population Aging on the Expenditure of Medical Insurance Fund for Urban Workers in China

Wang Shuling, Dou Lele, Shi Hui, Huang Zhe

亚洲社会药学 2023, 18 (3): 239-246.

摘要（51）

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Objective To explore the impact of population aging on the expenditures of medical insurance funds against the background that great changes in population structure influences economic development. Methods Through analyzing the impact of the population aging, the income and accumulated balance of the medical insurance fund, and other related factors on the expenditure of the medical insurance fund, development status of the medical insurance fund for urban employees in China since 2003 was obtained. Stata 16.0 was used to perform multiple linear regression analysis on related factors to determine the correlation between population aging and the change in medical insurance expenditures. Results and Conclusion The factors that have a greater impact on the expenditure of the medical insurance fund are the amount of income from the medical insurance, followed by the number of people over the age of 65 in China and the urban retired employees participating in medical insurance. We should focus on the sustainable development of the urban employee medical insurance fund to deal with the threat of aging.

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23. Study on Public Health Behavior against the Background of COVID-19 Pandemic - Based on Bandura Reciprocal Determinism

Di Haopu, Wang Shuling

亚洲社会药学 2023, 18 (4): 359-364.

摘要（50）

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Objective To explore the factors influencing public health behaviors in China in the context of COVID-19 pandemic, and to propose suggestions and countermeasures for enhancing public health behaviors. Methods A public health behavior system based on Bandura’s reciprocal determinism was constructed, and public health behavior was analyzed from the perspective of the interaction of health awareness, health behavior and environment. Results and Conclusion The public health behavior was analyzed through the public health behavior system based on Bandura’s reciprocal determinism, and the results and conclusions were draw. The public can be urged to develop better health beliefs and form better health behaviors by strengthening publicity and interventions, improving personal awareness, and increasing government investment.

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24.

Supervision of Public Opinion under the Background of Social Co-governance - Take the Changsheng Vaccine Incident as an Example

Ma Xiaonan, Tian Lijuan

亚洲社会药学 2023, 18 (3): 198-205.

摘要（50）

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Objective To provide reference for the news media to give play to the role of public opinion supervision in time based on the background of drug safety and social co-governance. Methods The method of case analysis was used to make a retrospective study on the Changsheng vaccine incident in 2018. Then the role of mainstream media, pharmaceutical media, and self-media in the supervision of public opinion was investigated. Results and Conclusion Both mainstream and pharmaceutical media played an excellent role in supervising the Changchun Changsheng vaccine incident. However, the content published by some pharmaceutical media was hard to understand by ordinary people. Besides, the role of self-media in public opinion supervision was polarized. Some self-media closely kept pace with mainstream media in public opinion supervision. Other self-media unilaterally pursued the click rate, publishing false information to guide wrong public opinion. The news media should optimize the supervision efficiency of drug safety. On the one hand, pharmaceutical media should pay attention to the fact that readers may not understand the difficult terms because they are not professional. On the other hand, self-media practitioners should improve their professional quality so that they will not publish some fake news to mislead public opinion.

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25.

Research on the Countermeasures for the Development of Biopharmaceutical Industrial Parks in China

Zhang Zongjie, Wu Zhiang

亚洲社会药学 2023, 18 (3): 232-238.

摘要（49）

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Objective To systematically analyze the current development status of biopharmaceutical industrial park in China, sort out the problems and put forward some countermeasures and suggestions. Methods Relevant literature was searched and reviewed to find out the problems faced by the development of biopharmaceutical industrial parks in China. Results and Conclusion Biopharmaceutical industrial parks are developing rapidly due to their unique industrial clustering advantages, but there are problems such as lack of overall planning at the top level, insufficient government support, imperfect talent support services and weak innovation capacity of the parks. It is recommended to promote the rapid development of biopharmaceutical industrial parks and biopharmaceutical enterprises by strengthening top-level design, increasing government support, focusing on talent introduction, and enhancing the innovative strength of the parks.

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26. Research on Reimbursement Management of Innovative Drugs Abroad and Its Enlightenment to China

Yu Hanshuang, Huang Xianqin, Wang Huiyan, Sun Lihua

亚洲社会药学 2024, 19 (1): 1-8.

摘要（49）

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Objective To analyze the reimbursement policies of innovative drugs in some developed countries, and to provide reference for future reimbursement management in China. Methods Literature research method was used to study the policies related to the reimbursement management of innovative drugs in Germany, France and Japan, and their successful experience was summarized. Results and Conclusion China should establish an open and transparent value evaluation standard to improve the medical insurance reimbursement management of innovative drugs. Besides, the value of innovative drugs should be taken as an important basis for reimbursement decisions, and an independent third-party value evaluation agency must be established.

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27.

Analysis and Enlightenment of Big Data Platform for Adverse Drug Reaction Supervision in China and the United States

Chang Senhao, Chang Yingnan, Gong Jingran, Chen Yuwen

亚洲社会药学 2023, 18 (3): 213-220.

摘要（47）

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Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the “14th five-year plan” to deepen the reform of medical and health system. Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process, operation mode, practical significance and characteristics of the big data platform for FDA regulatory science, which would help China to establish a perfect big database. Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States. It is necessary to build data platforms in line with China’s national conditions through efforts in law, talents, standards, and other aspects.

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28. Research on the Effect of R&D Investment Intensity and Sales Expense on the Performance of Biomedical Enterprises

Wang Lifei, Jia Zheng, Wu Dongming, Xinghua

亚洲社会药学 2023, 18 (4): 326-334.

摘要（46）

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Objective To explore the influence of new drug R&D investment and sales expense on the performance of biomedical enterprises. Methods The financial statements of 76 listed biomedical enterprises for 5 consecutive years were selected, and the data were modeled to study the effect of R&D investment and sales expense on the performance of biomedical enterprises by using financial indicators as tools and statistical methods of multiple linear regression. Results and Conclusion Under the premise that the weak related factors such as enterprise scale, life cycle and asset-liability ratio are set as unrelated variables, the R&D investment intensity of biomedical enterprises is negatively correlated with the current performance, which also shows that the R&D of biomedical enterprises has the characteristics of high risk. Besides, the influence of early R&D investment is delayed. However, the sales expense of leading biomedical enterprises with large scales have higher proportion. Meanwhile the greater sales expense of the same enterprise in different periods, the better the enterprise performance is. Biomedical enterprises should consider their own development stage to develop more patented drugs. Besides, they must formulate plans for allocating reasonable sales personnel and cost expense to ensure that enterprises can obtain better benefits.

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29. Research on the Impact of Independent R&D and Collaborative Innovation on Economic Performance in China’s pharmaceutical Industry

Li Wanting, Qiao Jiahui, Wang Su, Chen Yuwen

亚洲社会药学 2023, 18 (4): 315-325.

摘要（45）

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Objective To study the impact of independent R&D and collaborative innovation on economic performance in the pharmaceutical industry. Methods A panel regression model was established by selecting the panel data of China’s pharmaceutical industry from 2009 to 2019. Results and Conclusion Independent R&D and collaborative innovation of the pharmaceutical industry in eastern, central and western regions of China had a positive effect on economic performance. Besides, the promotion effect of independent R&D was greater than that of collaborative innovation. The positive driving effect of economic performance is the largest among the three regions, followed by the central and western regions. The collaborative innovation has the greatest positive effect on economic performance in the central region, followed by the eastern and western regions.

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30. The Status Quo and Enlightenment of the Foreign Extended Clinical Trial System

Teng Xinyi, Tian Lijuan

亚洲社会药学 2023, 18 (4): 335-344.

摘要（37）

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Objective To study the extended clinical trial systems in the United States, the European Union and Australia, and to provide a reference for the improvement of China’s extended clinical trial system. Methods Literature research method, risk management analysis method and comparative research were used in this paper to analyze the development history, scope of use, status quo of the extended clinical trial systems in the United States, the European Union, and Australia. Then, the current situation and shortcomings of China’s extended clinical trial system were compare with these foreign countries so as to put forward some suggestions for improvement. Results and Conclusion China should improve existing laws and regulations by establishing a fast application procedure, increasing application channels, and providing an information disclosure platform to meet the needs of patients in extended clinical trials.

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31. Inspiration of Foreign Innovative Drug Pricing Methods and Medical Insurance Payment Standards to China

Rao Xiuli, Sun Lihua

亚洲社会药学 2023, 18 (4): 365-373.

摘要（37）

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Objective To study the innovative drug pricing methods and medical insurance payment standards in foreign countries and to provide reference for China’s government. Methods The official websites were searched for information and related literature, and literature review was used. Results and Conclusion In foreign countries, the clinical value of innovative drugs and their impact on medical insurance funds were comprehensively evaluated based on factors such as quality-adjusted life years, clinical benefit, and improvement of clinical benefit. Then, the evaluation results were taken as an important basis for whether innovative drugs were admitted to the medical insurance catalog and establishing medical insurance payment standards. By using international experience for reference, innovative drug pricing methods and medical insurance payment standards for China’s national conditions can be improved by establishing a basic database of clinical value and drug economic evaluation of innovative drugs, as well as innovative drug payment models based on decision thresholds.

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32. An Exploration of Organizational Development in the Process of Innovation and Transformation of Pharmaceutical Enterprises - Taking X Pharmaceutical Enterprise as an Example

Gao Lin, Sun Lihua

亚洲社会药学 2024, 19 (1): 72-80.

摘要（33）

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Objective To study how to promote the smooth innovation and transformation of enterprises and enhance the market competitiveness of enterprises from the perspective of human resources organization development. In the wave of pharmaceutical industry reform, some entrepreneurs realize the importance of innovation and technology in the future. However, domestic pharmaceutical enterprises are still in the production-oriented stage. In the process of transformative innovation, pharmaceutical enterprises should not only rely on the support of scientific and technological and economic forces, but also need a suitable organizational change and many excellent talents as the source of development. Methods Through retrieving relevant literature and combined with the organizational development practice of X pharmaceutical enterprise, the organizational development model was explored in this paper. Results and Conclusion By forming a system of strategy, organization, talent, culture and mechanism, and building an organizational development model, we can improve the organizational atmosphere and organizational efficiency in the process of enterprise innovation and transformation, so as to enhance the competitiveness of enterprises in the market.

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33. Research and Enlightenment of Text Mining Applications in ADR from Social Media

Lin Xueyi, Pang Li, Huang Zhe, Lian Guiyu

亚洲社会药学 2024, 19 (1): 9-19.

摘要（31）

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Objective To discuss how to use social media data for post-marketing drug safety monitoring in China as soon as possible by systematically combing the text mining applications, and to provide new ideas and methods for pharmacovigilance. Methods Relevant domestic and foreign literature was used to explore text classification based on machine learning, text mining based on deep learning (neural networks) and adverse drug reaction (ADR) terminology. Results and Conclusion Text classification based on traditional machine learning mainly include support vector machine (SVM) algorithm, naive Bayesian (NB) classifier, decision tree, hidden Markov model (HMM) and bidirectional en-coder representations from transformers (BERT). The main neural network text mining based on deep learning are convolution neural network (CNN), recurrent neural network (RNN) and long short-term memory (LSTM). ADR terminology standardization tools mainly include “Medical Dictionary for Regulatory Activities” (MedDRA), “WHODrug” and “Systematized Nomenclature of Medicine-Clinical Terms” (SNOMED CT).

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34. Introduction of PIC/S Accession Procedure and Suggestions for Establishing a Unified Quality Management System in China

Hu Shigao, Wu Zhiang

亚洲社会药学 2023, 18 (4): 345-351.

摘要（30）

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Objective To introduce the accession procedure and evaluation of PIC/S, and help relevant departments in China to understand the requirements of PIC/S in detail, and to promote the process of China’s entry into PIC/S. Methods The procedures and steps of joining PIC/S, the evaluation process of PIC/S, and the experience of several countries in joining PIC/S were introduced and analyzed, which could help the relevant personnel in China understand the specific contents. Results and Conclusion According to the requirements of PIC/S, it is necessary to establish a unified GMP quality management system.

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35. Research on the Construction of Evaluation Model for the Development of Biopharmaceutical Park in China

Zhang Zongjie, Wu Zhiang

亚洲社会药学 2023, 18 (4): 387-397.

摘要（30）

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Objective To study the influencing factors on the development of biopharmaceutical park, and to construct an evaluation model of the influencing factors for biopharmaceutical park in China. Methods By analyzing various factors affecting biopharmaceutical parks, an evaluation index system of biopharmaceutical parks and an evaluation model of influencing factors of biopharmaceutical park development based on fuzzy group decision making were established. Results and Conclusion Factors such as research and development (R&D) funding investment, incentive for transformation of scientific and technological achievements, and industrial clusters have a greater impact on the development of biopharmaceutical industrial parks in China. Local governments should increase the investment in R&D funding. Besides, they should pay attention to the incentive of transformation of scientific and technological achievements to improve the innovation ability of enterprises. Meanwhile, they should promote the clustering of high-tech enterprises to comprehensively enhance the healthy development of biopharmaceutical parks in China.

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36. Comparative Study on the Policy of Multiplicity Issues in Clinical Trials at Home and Abroad

Gong Jingran, Chang Yingnan, Qiao Jiahui, Chen Yuwen

亚洲社会药学 2024, 19 (1): 43-49.

摘要（28）

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Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials, and to provide reference for the revision of China’s relevant guiding principles. Methods Based on ICH E9, the similarities and differences of the guiding principles of US Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Medical Products Administration (NMPA) on the multiplicity issues in clinical trials were compared one by one. Results and Conclusion In general, NMPA guidelines are based on ICH E9, but in detail, the guidelines of FDA and EMA focus differently on the multiplicity issues. Therefore, NMPA guidelines need to be detailed and comprehensive. NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.

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37. Research on the Status Quo and Optimization of Centralized Procurement of Coronary Stents

Zhang Yuting, Liu Xiaoxi

亚洲社会药学 2024, 19 (1): 20-28.

摘要（28）

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Objective To study the impact of the first national centralized procurement of coronary stents on patients’ psychology, the economy of medical institutions, and the survival and development of the coronary stents industry, and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents. Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital. Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients, but it has many problems. Therefore, this paper proposes some suggestions, such as promoting the orderly development of the coronary stent industry, improving the evaluation link of the centralized procurement of coronary stents, adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services.

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38. Foreign Experience and Enlightenment of Reimbursement Management of Multi-indication Drugs

Wang Huiyan, Yu Hanshuang, Sun Lihua

亚洲社会药学 2023, 18 (4): 352-358.

摘要（27）

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Objective To provide reference for China’s medical insurance reimbursement plan of multi-indication drugs. Methods By referring to relevant foreign literature, the implementation process and conditions of different reimbursement management modes of multi-indication drugs were analyzed to provide suggestions for reimbursement of multi-indication drugs in China. Results and Conclusion It is suggested to further explore the suitable conditions and select the corresponding mode in China. Payment standards should be set according to value pricing and budget impact analysis. Besides, data collection and analysis mechanism must be improved. Lastly, reward and punishment mechanism can be adopted to improve management efficiency.

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39. Problems and Countermeasures to Improve Clinical Trial Participants’ Compensation Rights in China

Yang Xiuqiao, Wen Ping, Lin Hong, Chen Wenhuan, Chen Yuwen

亚洲社会药学 2024, 19 (1): 58-63.

摘要（24）

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Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights. Methods The literature related to the participants’ right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects: insurance system, principle of attribution, legal relationship and compensation regulations. Then, some suggestions to improve the participants’ right to compensation were proposed. Results and Conclusion China lacks clear legal norms for participants’ right to compensation. There are problems such as unclear insurance rules and compensation rules, unclear contractual relationships between parties to clinical trials, and no laws and regulations to rely on for attribution and compensation. China should issue regulatory guidelines related to the right to compensation of participants in clinical trials, so that all parties in clinical trials can have rules to follow if there is the occurrence of injury, which can better protect the rights and interests of the participants.

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40. Comparative Analysis of Profit Model of Typical Pharmaceutical O2O Enterprises in China

Qu Simeng, Wang Shuling

亚洲社会药学 2024, 19 (1): 81-88.

摘要（23）

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Objective To study the profit model of Chinese pharmaceutical O2O enterprises. Methods A case study of three typical pharmaceutical O2O enterprises was conducted, and their profit models were compared. Results and Conclusion The pharmaceutical O2O enterprises in China are divided into three categories according to the profit models. It is found that the current pharmaceutical O2O enterprises have problems such as simple profit model and low corporate profits. Based on these problems, it is recommended that relevant enterprises develop various business models to increase profit channels. Besides, they should establish and improve internal cost control systems.

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