全部 标题 作者
关键词 摘要

OALib Journal期刊
ISSN: 2333-9721
费用:99美元

查看量下载量

相关文章

更多...

中药上市后再评价技术规范制定的必要性及其形成方法研究

Keywords: 上市后再评价,中药,技术规范,方法

Full-Text   Cite this paper   Add to My Lib

Abstract:

通过全面梳理WHO、美国及欧盟药物上市后再评价相关法律法规、技术规范和指南,对比我国中药上市后再评价的法规制度现状,发现由于中药上市后再评价起步较晚,尚未制定出相应的技术规范和指南,使得医院、企业和科研机构在开展相关工作时无据可依,比较混乱。因此制定中药上市后再评价技术规范迫在眉睫。该文在《国家标准制定程序》以及《中医药标准制定管理办法(试行)》等技术文件的指导下,结合我国中药上市后再评价的具体特点,探索出适合我国中药上市后再评价技术规范的制定方法,并就其制定程序和方法做以介绍,旨在为今后相关技术规范的制定提供方法学的参考和借鉴,以促进我国中医药事业的发展。

References

[1]  郭晓昕,颜敏,张素敏,等.对药品上市后安全性再评价若干问题的探讨[J].中国药学杂志,2001,36(3):205.
[2]  程鲁榕.药品呼唤上市后再评价[J].药物警戒,2005,2(4):220.
[3]  王永炎,杜晓曦,吕爱平. 中药上市后临床再评价设计方法与实施[M].北京:人民卫生出版社,2012:5.
[4]  张伯礼.扶持和促进大中药产业健康发展[J].中国食品药品监管,2010(5):8.
[5]  黄璐琦,李军德,李哲,等.我国现代大中药产业链发展趋势及对策[J].中国科技投资,2010,5:67.
[6]  中医药标准化中长期发展规划纲要(2011—2020年)[N]. 中国中医药报,2012-12-20(3).
[7]  白殿一,逢征虎,刘慎斋. 标准的编写[M].北京:中国标准出版社,2011:19.
[8]  廖星,谢雁鸣.共识法在传统医学临床实践指南制定过程中的应用探讨[J].中西医结合学报,2008,6(6):555.
[9]  颜敏,吴晔,郭小昕.药品上市后再评价技术规范与评价模式探讨[J].药物流行病学杂志,2003,12(6):286.
[10]  李少丽,王兰明,颜敏,等.关于在我国建立药品上市后再评价制度的探讨[J].中国新药杂志,2001,10(4):241.
[11]  桑斌生,杨海丰,李钟军.中医药标准化发展回顾与思考[J].中医药管理杂志,2009,17(8):675.
[12]  李振吉,贺兴东,姜再增.对中医药国际标准化建设的战略思考[J].世界中医药,2009,4(3):167.
[13]  World Health Organization Geneva. WHO policy perspectives on medicines. pharmacovigilance: ensuring the safe use of medicines[EB/OL]. 2004-10-02. http://apps.who.int/medicinedocs/en/d/Js6164e/.
[14]  World Health Organization. The importance of pharmacovigilance:safety monitoring of medicinal products[EB/OL]. 2002-02-01.http://apps.who.int/medicinedocs/en/d/Js4893e/.
[15]  World Health Organization Geneva. Safety of medicines:a guide to detecting and reporting adverse drug reactions[EB/OL]. 2002-02-01.http://apps.who.int/medicinedocs/en/d/Jh2992e/.
[16]  World Health Organization Geneva. Guidelines on safety monitoring of herbal medicines in pharmacovigilance systems[EB/OL]. 2004-10-02.http://apps.who.int/medicinedocs/en/m/abstract/Js7148e/.
[17]  Food and Drug Administration. Federal food, drug, and cosmetic act[EB/OL]. 2006-05-01. http://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act.
[18]  Food and Drug Administration. Food and drug administration amendments act of 2007[EB/OL].2007-10-01. http://en. wikipedia. org/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007.
[19]  Food and Drug Administration. Good pharmacovigilance practices and pharmacoepidemiologic assessment[EB/OL].2005-01-01.http://www.fda.gov/cder/guidance/index.htm.
[20]  Food and Drug Administration. Guideline for postmarketing reporting of adverse drug experiences[EB/OL].2001-01-01. http://www.fda.gov/cder/guidance/index.htm.
[21]  Food and Drug Administration. Society of health system pharmacists ASHP guidelines on adverse drug reaction monitoring and reporting[EB/OL].2005-01-01.http://www.ashp.org/s_ashp/docs/files/MedMis_Gdl_ADR.pdf.
[22]  European Commission.Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use[EB/OL]. 2001-01-01. http://apps.who.int/medicinedocs/en/m/abstract/Js17096e/.
[23]  田峰,谢雁鸣.欧盟人用医药产品警戒体系译介[J].中成药,2010,32(12):2154.
[24]  覃正碧,卢祖洵,吴晔.完善我国药品上市后风险管理探讨[J].医药导报,2009,28(2):267.
[25]  李曼,王忠,张象麟.对我国药品上市后再评价工作现状的认识和探讨[J].中国药物警戒,2011,8(4):225.
[26]  张欣涛,卢春来,平其能.我国现阶段有效实施《药品召回管理办法》的思考与建议[J].中国药房,2008,19(29):2241.
[27]  李博,高蕊,李睿.中成药上市后评价管理体制研究探讨探讨[J].医药导报,2012,21(23):2723.
[28]  国家中医药管理局. 中医药标准制定管理办法(试行)[EB/OL]. 2012-10-01. http://www.gsws.gov.cn/uploadfiles_2/File/20130122095040821.pdf.
[29]  Wilcox C M, Allison J, Benzuly K, Consensus development conference on the use of nonsteroidal anti-inflammatory agents, including cyclooxygenase-2 enzyme inhibitors and aspirin. [J].Clin Gastronenterol Hepatol,2006,4(9):1082.

Full-Text

Contact Us

service@oalib.com

QQ:3279437679

WhatsApp +8615387084133