-ICH 20周年文

协调促进健康事业---ICH 20周年文  

2014-12-01 17:40:01|  分类： ICH guideline|来源

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来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720141115401986/

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Shift in Emphasis 重点转移

Substantial benefits to DRAs resulted when ICH shifted emphasis from the input of information by industry to the output of information by regulators. This transition was made possible by the development of a common submission format—the CTD— which greatly influenced regulatory review processes, ultimately leading to a harmonized electronic submission and e-review initiatives, which, in turn, have enabled implementation of good review practices. These activities are having a global effect on information review and sharing among drug regulatory authorities.

当ICH将重点从收集企业信息转换至由法规人员输出信息时，该转换行为对DRA产生了巨大的利益。这种转换可能是由建立一种通用申报格式---CTD----来实现的。它极大地影响了法规评审过程，最终导致了统一的电子提交和电子评审，电子评审又使得优良评审规范成为可能。这些活动具有全球效应，使得药品法规当局可以在他们之间进行信息评审和共享。

Originally, ICH focused on input by industry— the technical submission requirements for pharmaceuticals for human use. Harmonizing the differences in these requirements through ICH guidelines helped industry reduce development times and save resources. To extend the benefits of harmonization, industry proposed assembling the building blocks of information intended for inclusion in a submission into a consistent harmonized format, referred to as the CTD, which would relieve pharmaceutical companies of the time, workforce, and financial burdens of assembling a submission for one DRA and then having to reformat it for another. This new consistent format also greatly benefited the U.S. Food and Drug Administration (FDA), enabling the agency to establish templates for each of the review disciplines while promoting more consistent review practices and processes.

起初，ICH关注于来自企业的信息---人用药技术评审要求。通过指南来统一这些要求之间的差异，帮助企业减少研发时间，节省资源。为了扩大统一化的利益，企业提议将申报资料所需的信息打包成模块，组合在一个统一的格式中，即CTD格式，这样可以节省制药公司用于一份DRA申报的时间、工作量和经济负担，用于另一个新药的申报。这种新的统一的格式也会极大有利于美国FDA，使得药监当局可以建立一些模板，用于各审核原则，促进审核规范和评审过程统一化。

Prior to the advent of the CTD, regulatory reviewers received an application from one company and spent a year or more engaged in its review. When the review was completed, reviewers received the next application—most likely in a different format—and had to learn the structure of the new application. As a result, review staff were constantly on a learning curve when new assignments were received—time they could have better used reviewing the information as opposed to simply trying to find it.

在CTD出现之前，法规评审人员收到一个公司的申报资料，然后需要花一年或更长的时间来进行评审。当评审结束后，评审员收到下一份申报资料----很可能是另一种不同的格式----然后不得不学习新申报的组织结构。结果是，评审人员在收到新的任务时必须不断地学习---其实他们可以利用这些时间更好地评审资料，而不是花费这些时间来寻找这些资料。

When industry proposed the CTD in 1996, ICH regulators were hesitant to change their submission formats, believing it would be too disruptive to the review process. They needed convincing that harmonizing the submission format had value. Regulators asked industry to do a feasibility study. That study, conducted in May 1996, evaluated the time it took to convert an FDA new drug application into an European Medicines Agency (EMA) submission, and the reverse. It also evaluated the number and types of staff needed to carry out the conversion of the submission formats. Regulators quickly saw the potential value of harmonizing submission formats.

当制药企业在1996年提议采用CTD格式时，ICH法规人员还犹豫是否要改变其申报格式，因为他们认为这样改变会对评审流程产生影响。他们需要说服药监当局这样对申报资料格式进行统一是有价值的。法规人员要求制药行业进行可行性研究。该研究在19956年6月进行，评估了将一份FDA新药申报资料转换成一份EMA申报资料格式所需的时间，以及反过来转换所需的时间。该研究还评估了进行申报资料格式转换所需的员工数目及不同专业。法规人员很快看到统一申报格式潜在的价值。

                               
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Regulatory Benefits 法规利益

The CTD has also made the exchange of information among drug regulatory authorities easier. For a number of years, FDA and the EMA have had a confidentiality arrangement in place allowing the sharing of confidential information, greatly increasing interactions between the two agencies. Now that submissions are received in the same format and, generally, at the same time, these interactions have become more efficient, facilitating discussions of common concerns as submissions are evaluated.

CTD还使得药品法规当局之间的信息交流变更更加容易。很多年来，FDA和EMA曾有一份保密安排，允许共享机密信息，这很大程度上增加了两个法规机构间的互动。现在，两者收到的申报资料是采用的相同格式，并且一般来说，是在同时收到，这些互动就变成更有效，且便于在对申报资料进行评估时对共同关注的问题进行讨论。

ICH regulators, impressed with the amount of time and effort involved in the conversion of one regulatory submission to another, agreed that the resources involved could be better used towards more research and development for new drug products. The regulators also realized that these conversions created a delay in submitting an application to the different ICH regions and, in turn, delayed patient access to new innovative medicine. The result of agreeing to work on a consistent format or table of contents is the ICH Common Technical Document.

ICH法规人员花了大量的时间和精力来转换格式，以按不同的地方要求提交申报资料。他们都认同这些资源其实可以更好地用于更多的新药研发工作。法规人员还意识到这些格式转换使得申报推迟，从而延迟了不同ICH区域内患者获得创新药的时间。这些对创建统一格式或内容共识通过努力最后得到的结果是ICH的CTD格式。

Module 1 is not part of the CTD, it represents the administrative information specific to each ICH region. Module 2 is a layering of information and includes an introduction, summaries, and overviews. More complete data are contained in modules 3, 4, and 5. Countries can, in effect, focus on modules of interest. If a regulatory authority is not interested in the complete datasets in modules 3, 4, and 5, the focus can be on modules 1 and 2. This is what some less-resourced countries are now doing.

模块1并不是CTD的一部分，它呈现的是各ICH地区内指定的行政信息。模块2是信息分层，包括介绍、总结和概述。完整的数据包括在模块3、4和5中。各评审国家可以只关注其感兴趣的模块。如果法规当局对模块3、4和5中的完整的全套数据不感兴趣，那可以只关注模块1和2。有些资源欠缺的国家目前就是这样来做的。

                               
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Last, and perhaps most important, the CTD has facilitated electronic submissions (the eCTD). In the past, drug applications were voluminous, delivered to FDA by the truckload due to the sheer amount of paper involved. When the agency first transitioned to electronic submissions, an application was on a compact disc or hard drive. Although this certainly helped with transportation and storage issues, it did not necessarily enhance the review process. FDA has now implemented the FDA Electronic Submission Gateway, which allows a new drug application (NDA) to be sent electronically, essentially very much like e-mail. After being assessed for completeness, a submission is immediately and fully accessible on the reviewer’s desktop. This innovation has alleviated the need for industry to create and assemble the many pieces of paper that constituted a traditional paper-based product application, organize the application, box thousands of pages, load the boxes on a truck, and deliver them to FDA— all before a reviewer could even begin the assessment process.

最后，可能是最重要的，CTD促进了电子提交（eCTD）。在过去，药品申报资料有很多卷资料，由于体积巨大，不得不用卡车送到FDA。当官方首次转换成电子提交时，申报资料就存贮在一张压缩盘中，或一只硬盘里。尽管这样肯定是有助于运输和存贮，但它还是不能促进审评程序的进步。FDA现在实施了FDA电子提交途径，它允许新药申报采用电子方式送达，基本上和电子邮件很相似。在进行完整性评估后，审评员在其桌面上即可以看到全部完整的申报资料。该创新减轻了企业准备和装订许多传统产品申报方式所需纸张、组织申报文件、将文件装箱、将箱装入卡车送至FDA的工作-----这些工作没做好的话，审评员甚至无法开始评审程序。

The eCTD has proved critical to improving application submission efficiencies as well as reviewer efficiency. Besides delivering submission material to the reviewer in an expedited manner, the eCTD format has made it easier to develop standardized reviewer e-templates and review tools for each of the review disciplines.

事实已经证明eCTD在提高申报效率和审评员效率方面非常关键。另外，eCTD格式使得申报资料可以快速提交给审评人员，使得审评人员易于建立标准化审评电子模板，对每个审评原则建立审评工具。

Another benefit of a harmonized format has been the ease of developing and implementing harmonized good review practices. What is evaluated in a review is closely tied to the requested data. As a result, there is considerable similarity between ICH guidance to industry and what we consider good review practices. Because ICH regions have harmonized much of the information submitted for marketing authorization, ICH regulators could easily begin moving toward similar review practices.

统一格式的另一个好处是易于建立和实施一致的优良审评规范。审评中评估的内容与所需要的数据紧密相关，因此，ICH对行业的指南与我们认为的优良审评规范是非常相似的。由于ICH地区已经统一了许多上市许可申报所需的信息，ICH法规人员可以很容易地开始采取相似的审评规范。

In general, good review practices promote transparency and consistency, both of which are very important if industry and the public are to understand how regulatory authorities carry out their responsibilities. This is especially important because of the complexity of the disciplines and specialties involved in the review process. We needed a consistent approach to evaluating submissions and reaching conclusions, and the CTD and eCTD have helped to achieve these goals.

一般来说，良好的审核规范可以促进审评的透明度和一致性。如果制药行业和公众要理解法规当局如何履行其职责的话，透明度和一致性都是很重要。考虑到审阅过程所需的原则性和专业性，这两者就显得尤其重要。我们需要有一种一致的方法来评估申报资料，得出结论，而CTD和eCTD则帮助达到这样的目标。

In summary, the CTD format influences the content of the review by imposing a consistent order of information and data. This shapes both the conduct of the review and the presentation of the results of the review and promotes good review practices and increased efficiencies. As more countries embrace ICH guidelines and the CTD format, a common regulatory language could evolve that will further promote interactions among drug regulatory authorities.

总的来说，CTD格式通过将信息和数据以一定顺序呈现的方式影响了审核的内容。这引导了审评的实施以及审核结果的表达，促进了优良审评规范，提高了效率。由于越来越多的国家开始采用ICH指南和CTD格式，通用的法规语言可能引起并进而促进药品法规当局的互动。

The ICH guidelines are giving medical writers improved guidance on how to interpret what FDA needs within a marketing application and provide the content to meet those needs. This in turn allows submission groups within drug development teams to focus their drug development plans and the communication around the data being generated from the execution of those plans. The end result has been faster, more concise, and higher quality submissions that ultimately not only aid regulators in their efforts to make decisions, but inevitably get health care products to patients in a more timely fashion.

ICH指南正在给药学编写人员提供一个改进过的指南，指导如何在一份上市申请中诠释FDA的需求，提供内容符合这些要求。这种情况使得药品研发团队里的申报小组可以集中关注其药品研发计划，和实施这些计划中产生的数据方面的交流。最终结果是使得申报更快速、更简洁及更高质量，不但大大帮助了法规人员做出决定，也必然使用得患者能更加及时地获得所需的保证健康的产品。

DAVID CLEMOW

Scientific Communications Consultant

Medical Information Sciences, Lilly

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eCTD申报（按申报类型划分）

2003年10月至2010年10月

申报类型	序列数
IND	87,574
NDA	35,665
ANDA	23,328
BLA	11,003
MF	2,089
其它	951
合计	160,606

In December 2009, the U.S. Food and Drug Administration (FDA) processed its 100,000th eCTD submission. What began as a trickle in October 2003 has become a major component of FDA’s regulatory processes. When coupled with the Electronic Submission Gateway we can begin to see an end-to-end, standards-based, electronic receipt, review, and dissemination environment taking shape.

在2009年12月，美国FDA处理了第1百万件eCTD申报资料。eCTD在2003年10月还只有很少量，现在已经成了FDA法规处理的主要内容。与电子递交途径放在一起，我们可以开始看到一个从一端到另一端，基于标准，电子收条、电子审评，以及传播环境逐渐成形。

ICH efforts to standardize regulatory content and processes have moved research and healthcare data standardization efforts forward in dramatic fashion, as the recent eCTD submission statistics attest.

ICH致力于法规内容标准化，其努力已推进研发和保康保证数据标准化以激动人心的方式向前发展，其发展已经在最近的eCTD申报统计数据中得到了证明。

HELLE GAWRYLEWSKI

Head Alliance Management

Johnson & Johnson

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