亚洲社会药学

本期目录

2015年, 第10卷, 第3期　刊出日期：2015-09-20 上一期    下一期

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Regional Studies of Bio-pharmaceutical Industry in China YANG Bo;HUANG Tai-kang 2015 (3):  111-115.  doi: 摘要 ( 350 )   Objective To provide strategies for the development of bio-pharmaceutical industry in China. Methods The characteristics of regional distribution, the development of key bases and the development trend of regional bio-pharmaceutical industry were analyzed. Results and Conclusion It is suggested that bio-medical industry in China should establish an evaluation system of innovation, carry out regional overall planning, make good use of resources, encourage the division of labor, upgrade the environment of industrial zone and promote the development of enterprise clusters. 相关文章 | 计量指标

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Current Situation and Development Trendsof Pharmaceutical Market in China WANG Shu-ling;LI Xuan 2015 (3):  116-122.  doi: 摘要 ( 349 )   Objective To discuss the current situation of pharmaceutical market and to predict its development trends in China. Methods Multiple methods were adopted: Firstly, data were collected from internet and through document survey method. Secondly, SWOT methods was used to analyze Chinese pharmaceutical market from four aspects, including advantages, disadvantages, opportunities and threats. Finally comparative analysis methods were used in both R&D investment and market concentration. Results and Conclusion Pharmaceutical market in China lacks of inter-disciplinary talents, and its supervision system is imperfect. Based on the situation of pharmaceutical market, a prediction is made concerning its international status, consumption structure, enterprise situation and its key development areas. 相关文章 | 计量指标

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Analysis and Evaluation of Measures for the Administrationof Medical Device Registration LI Fei;BI Kai-shun 2015 (3):  123-129.  doi: 摘要 ( 287 )   Objective To study Measures for the Administration of Medical Device Registrations published by CFDA in 2014 and to summarize its impact on medical device market access in China. Methods Comparative study was adopted to conduct a research on the new and old measures for the administration, and systematic analysis was used to study the innovations of the measures for the administration. Results and Conclusion The new measures for the administration have made some improvements in the statutory code, efficiency and convenience as well as unity of licensing and supervision as an administrative license system. Additionally, the new provisions have made innovations on the subject qualification, evaluation principles and evaluation system. In order to implement the new measures for the administration, further reforms should be carried out on the uniform standards and personnel training to promote the registration management system. 相关文章 | 计量指标

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GMP Regulations in China: Problems and Countermeasures ZHU Shui-qing;SUN Li-hua 2015 (3):  130-134.  doi: 摘要 ( 285 )   Objective To discuss the problems and their causes in GMP regulations and to provide references for improving GMP regulations in China. Methods The relevant literatures in the China National Knowledge Infrastructure (CNKI) were systematically studied to explore the problems of GMP implementation and the causes. And corresponding countermeasures and suggestions were raised to provide references for making relevant decisions. Results and Conclusion GMP for drug quality assurance depends not only on the rationality of GMP standards, but also on the implementation of GMP standards. Rational GMP standards and their implementation are the key part for pharmaceutical production quality assurance. 相关文章 | 计量指标

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Analysis of the Roles and Obligations ofPharmaceutical Industry in Pharmacovigilance MAO Xiao-fang;YANG Yue 2015 (3):  135-138.  doi: 摘要 ( 316 )   Objective To clarify the roles and obligations of pharmaceutical industry in pharmacovigilance and to provide references of supervision for the authorities which will contribute to enhancing effective interaction both in information communication and implementation of decisions between industries and the authorities. Methods Provisions related to obligations of pharmaceutical industry in the context of current laws and regulations were analyzed. Results and Conclusion Pharmaceutical industry should submit RMP and PSUR to ensure drug quality and truthfulness of promotional materials, monitor ADRs of products, conduct postmarketing study and risk communications as well as risk interventions. 相关文章 | 计量指标

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Risks and Risk Control Measures ofin vivo Genotoxicity Test in New Drug R&D LI Hui;HUANG Zhe 2015 (3):  139-142.  doi: 摘要 ( 286 )   Objective To provide risk identifying factors for false positive or false negative risk identification in vivo genotoxicity test of new drug research and development and to propose the relevant risk control measures. Methods Risk factors were identified through literature review and in combination with the “Drug Registration Management Measures” and toxicology studies guiding principles in ICH. Results and Conclusion Risks of in vivo genotoxicity test are analyzed in view of the risks of false positive result or false negative result. And the risk control measures are proposed according to the features of in vivo genotoxicity test. The false negative risk of in vivo genotoxicity test is drug pharmacokinetic risk, the false positive risk is the risk of experimental animal physiological conditions change. The failure risk of in vivo genotoxicity test can be reduced by conducting more in vivo tests and monitoring the biological index of the experimental animals frequently to remove the interferences. 相关文章 | 计量指标

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Risk Reviews of Preclinical Pharmaceutical Studieson Traditional Chinese Medicine Injection YANG Na;CHEN Yu-wen 2015 (3):  143-148.  doi: 摘要 ( 345 )   Objective To analyze the risks of preclinical pharmaceutical research on TCM injections according to the application dossiers of traditional Chinese medicine (TCM). Methods Process of clinical pharmaceutical research on traditional Chinese medicine (TCM) injections and its potential risk control points were analyzed based on the cycle of research and development of TCM injections, expert consultations and literature reviews. Results and Conclusion Six research stages with high risks should be focused on in order to improve the R&D efficiency of traditional Chinese medicine injection. 相关文章 | 计量指标

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Research on the Development of Clinical Pharmacyin Secondary Medical Institutions LI Xue-jiao;;TIAN Li-juan 2015 (3):  149-153.  doi: 摘要 ( 301 )   Objective To discuss the development of clinical pharmacy in secondary medical institutions. Methods Literature review was conducted to analyze the situation of clinical pharmacy in secondary medical institutions and some suggestions were raised to promote clinical pharmacy practices in secondary medical institutions. Results and Conclusion The development of pharmacy in secondary medical institutions should be based on the development of clinical pharmacy. A suitable clinical pharmacy education system should be established, and relevant laws and regulations must be improved to promote the development of clinical pharmacy in secondary medical institutions. 相关文章 | 计量指标

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Hot Issues about Drug Price in China from the Viewof Internet Public Opinion Monitoring GUAN Yi-ru;ZHANG Fang;WU Zhi-ang;LI Shu-quan 2015 (3):  154-160.  doi: 摘要 ( 302 )   Objective To obtain and analyze the hot issues about drug price in China through Internet public opinion monitoring and to provide references for Chinese government in relevant decision-making processes. Methods All networks were monitored every other day by putting in the key words of drug, price and pricing through using Shunsu Internet public opinion monitoring software. Collected data were verified by two researchers to ensure immediacy and usefulness. The monitoring lasted for a year from October 2012 to September 2013. Results and Conclusion A total of 560 pieces of valid information were extracted, focusing on maximum retail price adjustment, drug’s zero price margin, drug price regulation, etc. Large differences existed between provinces on the amount of information. The amount of public opinion about any issues was closely linked with government policy of that time. Internet public opinion monitoring has been proved to be an effective tool for Chinese government to know the public reflection on policy. Future work should focus on connection of monitoring results and policy decision-making. 相关文章 | 计量指标

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Australian PBS and Its Enlightenment to Drug Price Reform in China ZHENG Qi;ZHANG Fang 2015 (3):  161-166.  doi: 摘要 ( 294 )   Objective To study Australian Pharmaceutical Benefits Scheme (PBS) and to provide references for drug price reform in China. Methods The real-time information from the PBS website was searched and literatures on health care system in Australia were studies to sum up the process and methods of PBS. Results and Conclusion Australia effectively controls the growth of medical expenses and the average price of medicines is 30%–40% lower than OECD’s through strict control of PBS and setting the rational prices. The introduction of PBS and the control of drug price has a guiding significance in promoting drug price reform in China so as to lower drug prices reasonably. 相关文章 | 计量指标