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European Medicines Agency: leave the UK but remain the same.

作者信息

Garattini Livio, Curto Alessandro

机构信息

IRCCS Institute for Pharmacological Research Mario Negri, Ranica 24020, Italy

IRCCS Institute for Pharmacological Research Mario Negri, Ranica 24020, Italy.

出版信息

J R Soc Med. 2016 Sep;109(9):324-5. doi: 10.1177/0141076816663559.

DOI:10.1177/0141076816663559
PMID:27609795
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5017522/
Abstract
摘要

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European Medicines Agency: leave the UK but remain the same.欧洲药品管理局:离开英国但保持不变。
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Drug approval and research assessment: arguments for reform.药物审批与研究评估:改革的论据
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3
Rationing new medicines in the UK.英国新药品的配给
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European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond.欧洲药品管理局对用于上市许可及后续阶段的肿瘤学研究设计的观点
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From the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit.从欧洲药品管理局到奥比斯项目:英国脱欧后促进肿瘤药物批准的新活动和挑战。
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For the European Medicines Agency, a decade of challenges.对于欧洲药品管理局来说,这是充满挑战的十年。
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European Medicines Agency pledges to publish clinical reports.欧洲药品管理局承诺发布临床报告。
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Comparing patient access to pharmaceuticals in the UK and US.比较英国和美国患者获取药品的情况。
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Medicines to remain with European Commission health directorate.药品将留在欧盟委员会卫生司。
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Regulatory watch: Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective.监管观察:中枢神经系统疾病药物研发面临的挑战:欧洲药品管理局视角
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Pharmaceutical pricing conundrum: time to get rid of it?药品定价难题:是时候解决它了吗?
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Competition in pharmaceuticals: more product- than price-oriented?制药行业的竞争:更多以产品而非价格为导向?
Eur J Health Econ. 2018 Jan;19(1):1-4. doi: 10.1007/s10198-017-0932-4.
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Dutch guidelines for economic evaluation: 'from good to better' in theory but further away from pharmaceuticals in practice?荷兰经济评估指南:理论上“从好到更好”,但在实践中与药品的距离却更远了?
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Market approval for drugs in the EU: time to change direction?欧盟药品的市场批准:是时候改变方向了吗?
Eur J Health Econ. 2017 Nov;18(8):933-936. doi: 10.1007/s10198-016-0863-5.
8
Drug approval and research assessment: arguments for reform.药物审批与研究评估:改革的论据
J R Soc Med. 2016 Sep;109(9):323. doi: 10.1177/0141076816666996. Epub 2016 Aug 17.

本文引用的文献

1
The European Medicines Agency is still too close to industry.欧洲药品管理局与制药行业关系仍过于紧密。
BMJ. 2016 May 6;353:i2412. doi: 10.1136/bmj.i2412.
2
Pharmaceutical Price Schemes in Europe: Time for a 'Continental' One?
Pharmacoeconomics. 2016 May;34(5):423-6. doi: 10.1007/s40273-015-0377-5.
3
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.从适应性许可到适应性途径:采用灵活的全生命周期方法将新药带给患者。
Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4.
4
Could co-payments on drugs help to make EU health care systems less open to political influence?药品的自付费用能否有助于使欧盟的医疗保健系统减少受到政治影响?
Eur J Health Econ. 2013 Oct;14(5):709-13. doi: 10.1007/s10198-012-0428-1.
5
Designing "Real-World" trials to meet the needs of health policy makers at marketing authorization.设计“真实世界”试验以满足药品上市许可时卫生政策制定者的需求。
J Clin Epidemiol. 2011 Jul;64(7):711-7. doi: 10.1016/j.jclinepi.2010.12.010. Epub 2011 Mar 31.
6
Modeling in pharmacoeconomic studies: funding sources and outcomes.药物经济学研究中的模型构建:资金来源与结果。
Int J Technol Assess Health Care. 2010 Jul;26(3):330-3. doi: 10.1017/S0266462310000322.
7
Pricing and reimbursement of in-patent drugs in seven European countries: a comparative analysis.七个欧洲国家专利期内药品的定价与报销:一项比较分析
Health Policy. 2007 Aug;82(3):330-9. doi: 10.1016/j.healthpol.2006.11.004. Epub 2006 Nov 27.