2016 新药临床数据公开（中英文）

20 October 2016 EMA/650519/2016

Opening up clinical data on new medicines

新药临床数据公开

EMA provides public access to clinical reports

EMA将向公众提供临床报告入口

As of today, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for humanuse authorised in the European Union (EU).

从今天起，EMA将向公众提供EU境内批准的人用新药临床数据的入口。

Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said "Transparency is an essential componentin clinical research. Its outcome – whether positive or negative – should be made publicly available. EMA's transparencyinitiative will make Europe a true front runner with respect to release of data concerning clinical trials. It will create a bridgefrom now until the new Clinical Trials Regulation - which foresees additional milestones towards transparency, becomesapplicable."

EC卫生和食品安全欧洲委员会专员Vytenis Andriukaitis说，“临床研究中，透明度是一个基本要素。其结果—无论是肯定还是否定---均应让公众获知。EMA的透明度倡议会让欧洲在临床研究数据披露方面成为真正的先行者。它将成为现在到新临床研究法规生效期间的桥梁，它预见了迈向透明度的里程碑。”

For every new medicine, citizens, including researchers and academics, will be able to directly access thousands ofpages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing-authorisationapplications. Clinical reports give information on the methods used and results of clinical trials conducted on medicines.EMA is the first regulatory authority worldwide to provide such broad access to clinical data.

每一种新药、每位公民，包括研究所和学术界，将可以直接查看制药公司在上市许可申报中向EMA提交的成千上万页临床报告。临床报告提供了对药品进行临床试验时所用方法及临床试验结果的信息。EMA是全球第一个提供如此多临床信息的法规机构。

“Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise togive access to the data on which our recommendations are based”, explained EMA’s Executive Director Guido Rasi.“Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practiceof medicine as a whole.”

“临床数据的透明度是EMA长期以来所承诺的，今天，我们实现这个承诺，向公众提供我们建议所依据的数据的入口，”EMA的执行主任Guido Rasi说，“我们的倡议已经引起了全球对于更大透明度的讨论。这有利于学术研究和将药品作为一个整体的做法。”

With EMA’s proactive approach to providing access to the data, patients and healthcare professionals will be able tofind out more information about the data underpinning the approval of medicines they are taking or prescribing.

EMA主动提供数据入口后，患者和卫生专业人员可以找到更多关于他们所服用的或者是处方的药品批准背后的数据的信息。

It will also facilitate the independent re-analysis of data by academics and researchers after a medicine has beenapproved. This will increase scientific knowledge, and potentially further inform regulatory decision making in the future.

这还会推进药品批准之后学术和研究工作者的独立再分析工作。这些工作将增加科学知识，并可能在将来进一步报告法规方面的决策。

Increased transparency will also benefit innovation. The shared knowledge about a medicine helps developers learn from the experience of others and can lead to more efficient medicine development programmes.

透明度的增加还有利于创新。分享的药品知识有助于开发人员从其它人的经验中学习，可能导致更有效的药品开发进程。

“Patients and clinicians have been waiting a long time for clinical trial data. This new approach will at last provide transparent information on all results of clinical trials, positive or negative, as submitted to the EMA”, commented YannLe Cam, Chief Executive Officer of EURORDIS-Rare Diseases Europe and member of the EMA’s ManagementBoard. “We expect this to enhance trust in the medicines approval system. Access to this new knowledge base canhelp to accelerate innovation by reducing duplication of research and de-risking some new developments.”

“患者和临床医生已经等待临床数据等了很久。这种新的方法最终提供了所有提交给EMA的临床试验结果的信息，阳性和阴性的，” EMA管理委员会成员和欧洲罕见病高峰论坛首席执行官Yann Le Cam说，“我们期望这样能够促进药品批准系统中的信任感。能够进入这些新的知识库可以有助于加快创新，减少重复研究，消除新研究项目的风险”。

Innovative policy on proactive publication of clinicaldata主动发布临床数据方面的创新政策

The publication of the clinical reports follows the adoption by EMA of a policy on the publication of clinical data forhuman medicines. During the development process the Agency extensively consulted with all stakeholders concerned,making sure to integrate their sometimes divergent views.

公布临床报告是在EMA采纳了一份关于人药临床数据公开的政策之后实施的。在官方研究此流程时，我们征求了所有相关干系人的意见，确保统一大家有时不太一致的观点。

The website, available at https://clinicaldata.ema.europa.eu, will include the clinical reports contained in all initialmarketing-authorisation applications submitted to the Agency on or after the policy's entry into force on 1 January 2015.The policy also applies to applications submitted on or after 1 July 2015 to vary a marketing authorisation for anextension/ a modification of indication or a line extension. The documents are published once the EuropeanCommission decides whether or not to grant a marketing authorisation; the documents will also be published whenapplications are withdrawn before an EMA opinion has been given.

上述网址中包括在所有在2015年1月1日政策开始实施后提交给官方的初始上市许可申报资料中的临床报告。政策还适用于2015年7月1日起提交的对上市许可申报的关于扩大/修订适应症或扩大产品线的变更。该文件将在EC决定是否批准上市许可之后公布，如果申报在EMA做出决定之前被撤回也会公布。

As a first step, EMA is publishing today data for two medicines, representing approximately 260,000 pages ofinformation for over 100 clinical reports. Data will be progressively added online for all applications concerned sincethe policy entered into force. This will be a learning curve for the Agency and all its stakeholders, as they start to applythe policy for the first time. While the policy gives an unprecedented proactive access to clinical data, it also demandsthe highest standard of protection of patients’ personal data. The process will evolve over time as more experience isgained and may lead to adaptations of EMA’s guidance.

作为第一步，EMA今天发布了2个药品的数据，有超过100个临床报告的约26万页资料。从政策生效开始，所有相关申报资料的数据将会逐步增加。由于官方首次开始实施此政策，这将成为官方及所有干系人的学习曲线。虽然政策提供了前所未有的临床数据主动公开入口，这也需要对患者个人数据提供最高标准保护。该流程会逐步演化改进，因为在实施中会获得更多经验，可能会引发EMA指南的修改。

Once the process is fully implemented and the backlog has been dealt with, EMA aims to publish the reports 60 daysafter a decision on an application has been taken, or within 150 days after the receipt of the withdrawal letter. EMA iscommitted to these timelines. However, given the volume of work in publishing these reports, which will have to beundertaken with existing resources, EMA may need to re-assess their feasibility. According to current forecasts, EMAexpects to offer access to approximately 4,500 clinical reports per year.

一旦程序全部实施，并将积压数据全部处理，EMA将会致力于在对申报资料做出决定之后60天，收到撤回函之后150天发布报告。EMA承诺了上述时间表。但是，考虑到发布这些报告的工作量很大，并且需要在现有资源的基础上完成，EMA可能会需要重新评估是否可行。根据目前预测，EMA期望每年能提供约4500份临床报告供参阅。

Notes 注

1.    This press release, together with all related documents, is available on the Agency's website.

此文以及所有相关文件可从此网址找到。

2.    The clinical data website is accessible here.

此链接是临床数据网站

3.    The two medicines for which data is published today are Kyprolis (carfilzomib), an orphan cancer medicine for the treatment of multiple myeloma, and Zurampic (lesinurad), a medicine for gout.

今天公布数据的2个药品是Kyprolis（卡非左米），一个孤儿癌症用药，用于多发性骨髓瘤治疗，和Zurampic（雷西纳德），一种痛风用药。

4.    More information on EMA’s policy on publication of clinical data is available on our website here.

关于EMA公布临床数据政策的新消息可以在我们官网上找到。

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5.    On the basis of the data submitted to EMA, now available on the clinical data website, the Agency providesrecommendations on whether a medicine should be authorised for use in the EU. The assessment reports for allthese scientific opinions are available here on our website.

官方根据提交给EMA的数据决定是否在EU批准该药品上市，现在这些数据可以在临床数据网站上找到。所有这些科学观点的评估报告可以在我们官网上找到。

6.    More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu

更多关于EMA工作的信息可以在此官网找到。

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