EMA's response to articles

Andreas Pot

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EMA's response to articles

机译：EMA对文章的回应

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Two recent BMJ articles have given the European Medicines Agency (EMA) useful feedback from the academic community on its provision of information on the scientific review of medicines. The agency is grateful for and open to suggestions on how this can be improved. The authors of both articles ignore recent steps that the agency has taken to improve the transparency and presentation of this information. The agency's new policy on access to documents,3 which became effective in, November 2010, has pushed transparency further forward than in most other drug regulatory authorities. It grants wider access than ever before to documents originated, received, or held by the agency, including clinical trial reports submitted as part of marketing-authorisation applications. There will be a move towards proactive publication of more of these documents overthe next few years.

机译：最近两次BMJ文章给欧洲药品局(EMA)有用的反馈学术界对其提供信息科学审查药物。建议可以改善。最近这两篇文章的作者忽略的步骤该机构采取了提高透明度和表示这些信息。机构的新政策在访问文件,32010年11月,成为有效的吗进一步推动透明度比大多数其他药品监管当局。比以往更广泛的访问文件起源、获得或持有的机构,包括临床试验报告提交销售许可的应用程序的一部分。将会有一个转向积极主动在出版更多的文档未来几年。

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来源
《BMJ: British medical journal》 |2011年第7812期|1380-1380|共1页
作者
Andreas Pot;
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作者单位

European Medicines, Agency, London E144HB.UK;

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原文格式 PDF
正文语种英语
中图分类医药、卫生;
关键词
GRANTS; Transparency; Clinical TrialAGENCIES;

机译：赠款;透明度;临床TrialAGENCIES;

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1. EMA and the European Ombudsman react to Prescrire's article about EMA transparency [J] . Prescrire international . 2023,第249期

机译：EMA and the European Ombudsman react to Prescrire's article about EMA transparency
2. EMA's response to Prescrire's analysis of EMA's transparency policy over the last 10 years [J] . Prescrire international . 2022,第240期

机译：EMA's response to Prescrire's analysis of EMA's transparency policy over the last 10 years
3. Response to Letter to Reply to the authors' response to the letter to the editor concerning the article "Randomized control trial on the effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy" [J] . Ikechebelu Joseph Ifeanyichukwu, Eleje George Uchenna, Joe-Ikechebelu Ngozi NnekaOkafor Chidimma DonatusOkpala Boniface ChukwunemeUgwu Emmanuel OnyebuchiNwachukwu Cyril EmekaOkoro Chukwuemeka ChukwubuikemOkam Princeston Chukwuemeka Archives of gynecology and obstetrics. . 2023,第5期

机译：Response to Letter to Reply to the authors' response to the letter to the editor concerning the article "Randomized control trial on the effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy"
4. Automatic Tagging Time-Revealing Vocabulary from Thai Article News [C] . . 2005

机译：Thai Article News的自动标记时间显示词汇
5. Effects of 12-Week Moderate Resistance Training on Hormonal Responses and Muscular Fitness in the Elderly =12週中強度漸進阻力訓練對高齡者賀爾蒙與肌肉適能之影響 [D] . Lin, Chien-Ting. 2020

机译：Effects of 12-Week Moderate Resistance Training on Hormonal Responses and Muscular Fitness in the Elderly =12周中强度渐进阻力训练对高龄者贺尔蒙与肌肉适能之影响
6. A new monoclonal antibody to epithelial membrane antigen (EMA)-E29. A comparison of its immunocytochemical reactivity with polyclonal anti-EMA antibodies and with another monoclonal antibody HMFG-2. [O] . E. Heyderman, I. Strudley, G. Powell, 1985

机译：一种新的针对上皮膜抗原（EMA）-E29的单克隆抗体。与多克隆抗EMA抗体和另一种单克隆抗体HMFG-2的免疫细胞化学反应性比较。
7. http://jtd.amegroups.com/article/view/7577/7006 http://jtd.amegroups.com/article/view/7521/7007 http://jtd.amegroups.com/article/view/7499/7008 http://jtd.amegroups.com/article/view/7520/7009 http://jtd.amegroups.com/article/view/7094/7010 http://jtd.amegroups.com/article/view/7603/7011 http://jtd.amegroups.com/article/view/7490/7012 http://jtd.amegroups.com/article/view/7243/7013 http://jtd.amegroups.com/article/view/7045/7014 http://jtd.amegroups.com/article/view/7224/7015 http://jtd.amegroups.com/article/view/7341/7016 http://jtd.amegroups.com/article/view/7524/7017 http://jtd.amegroups.com/article/view/7526/7018 http://jtd.amegroups.com/article/view/7495/7019 http://jtd.amegroups.com/article/view/7518/7020 http://jtd.amegroups.com/article/view/7582/7021 http://jtd.amegroups.com/article/view/7643/7022 http://jtd.amegroups.com/article/view/7494/7023 http://jtd.amegroups.com/article/view/7447/7024 [O] . Sai-Bo Pan, Jian-Bin Zhang, Bai-Qin Zhao, 2016

机译：http://jtd.amegroups.com/article/view/7577/7006 http://jtd.amegroups.com/article/view/7521/7007 http://jtd.amegroups.com/article/view/7499/7008 http://jtd.amegroups.com/article/view/7520/7009 http://jtd.amegroups.com/article/view/7094/7010 http://jtd.amegroups.com/article/view/7603/7011 http://jtd.amegroups.com/article/view/7490/7012 http://jtd.amegroups.com/article/view/7243/7013 http://jtd.amegroups.com/article/view/7045/7014 http://jtd.amegroups.com/article/view/7224/7015 http://jtd.amegroups.com/article/view/7341/7016 http://jtd.amegroups.com/article/view/7524/7017 http://jtd.amegroups.com/article/view/7526/7018 http://jtd.amegroups.com/article/view/7495/7019 http://jtd.amegroups.com/article/view/7518/7020 http://jtd.amegroups.com/article/view/7582/7021 http://jtd.amegroups.com/article/view/7643/7022 http://jtd.amegroups.com/article/view/7494/7023 http://jtd.amegroups.com/article/view/7447/7024
8. Barrier Breaching Processes and Barrier Spit Breach, Stone Lagoon, California; Journal article [R] . Kraus, N. C., Militello, A., Todoroff, G. 2002

机译：Barrier Breaching processes and Barrier spit Breach，stone Lagoon，California; Journal article

EMA's response to articles

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