亚洲社会药学

本期目录

2023年, 第18卷, 第2期　刊出日期：2023-06-25 上一期   

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Strategic Planning for Drug Regulatory Science in the United States and Its Enlightenments to China Chang Yingnan, Gong Jingran, Chang Senhao, Chen Yuwen 2023 (2):  91-97.  摘要 ( 490 )   PDF(805KB) ( 246 )   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. 相关文章 | 计量指标

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Research on the Regulatory Framework of Advanced Therapies in the European Union and the United States Wulan Qiqige, Yang Yue, Huang Zhe 2023 (2):  98-106.  摘要 ( 442 )   PDF(914KB) ( 126 )   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. 相关文章 | 计量指标

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Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces Cui Yihang, Chen Binbin, Sun Lihua 2023 (2):  107-115.  摘要 ( 437 )   PDF(899KB) ( 121 )   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. 相关文章 | 计量指标

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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 2023 (2):  116-127.  摘要 ( 366 )   PDF(1099KB) ( 125 )   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. 相关文章 | 计量指标

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Research on Liposomal Irinotecan in Combination with 5-FU/LV for Metastatic Pancreatic Ductal Adenocarcinoma Wang Wenjun, Wang Yaoling, Huang Zhe 2023 (2):  128-136.  摘要 ( 351 )   PDF(1587KB) ( 113 )   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. 相关文章 | 计量指标

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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 2023 (2):  137-148.  摘要 ( 362 )   PDF(908KB) ( 93 )   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. 相关文章 | 计量指标

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Influence and Suggestions on Trial Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes Li Wanying, Zhang Weiwei, Jia Siyao, Dong Li 2023 (2):  149-156.  摘要 ( 342 )   PDF(871KB) ( 99 )   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. 相关文章 | 计量指标

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Study on the Management of Chronic Diseases in American and British Community Pharmacy Chen Qianqian, Tian Lijuan 2023 (2):  157-164.  摘要 ( 417 )   PDF(773KB) ( 96 )   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. 相关文章 | 计量指标

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Investigation on the Current Situation of China’s DTP Pharmacy and Suggestions for Its Development Wen Dong, Dou Lele, Sun Yuyuan, Wang Shuling 2023 (2):  165-176.  摘要 ( 351 )   PDF(1965KB) ( 395 )   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. 相关文章 | 计量指标

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Enlightenment and Suggestions on the Construction of Information Platform and Processing Mechanism of Drug Shortages in Developed Countries to China Cui Li, Xing Hua 2023 (2):  177-186.  摘要 ( 259 )   PDF(817KB) ( 155 )   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. 相关文章 | 计量指标