【讨论】Electronic Submission of Marketing Authorisation Dossiers

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"How and to whom shall I submit my dossier?" - this question is No 28 of EMA's Q&A document on procedural issues in the context of the centralised procedure ("re-authorisation Procedural Advice for Users of the Centralised Procedure"; EMA/339324/2007). The answer to this question was updated in December 2013 and describes the approach to the submission of a dossier in the electronical format in the context of the centralised procedure (since the 1st of January 2010, all paper submissions have been rejected). The answer contains references to documents and Guidelines which have been also recently updated.

In the following, you will find a short summary of each chapter:
•Language : Only English is accepted.
•Format :eCTD is the only acceptable format. The newest electronical standards and specifications (Stand: November 2013) have to be considered. These "Electronic Standards for the Transfer of Regulatory Information (ESTRI)" have been developed by ICH's M2 Expert Working Group and are maintained by the eCTD Implementation Working Group (eCTD IWG). The newest updates concern the standards of module 1 (Regional Information).
•Cover letter: No additional and separate copies should be sent, e.g. CD/DVDs, as they will create delays in processing.
&#8226roduct Information (PI): The PI has to be submitted both within the module 1 of the eCTD (as PDF) and as separate document (in Word format) outside the eCTD structure but in the same eSubmission Gateway.
•Active Substance Master File (ASMF): The applicant must ensure that the ASMF (the "closed" part) is submitted as soon as possible by the ASMF holder.
•Submission to the EMA.:The dossier should be submitted via the eSubmission Gateway or the eSubmission Web Client. The additional submission of CD-ROM or DVD leads to delays in the handling of applications. Applicants who are not yet using the Gateway or the Web Client (i.e. for technical reasons) should send their applications as CD-ROM or DVD for the attention of the Product and Application Business Support of the EMA (PA-BUS; see Q&A document for the detailed address).
•Submission requirements for the different Committee (Co-) Rapporteurs: After receiving the confirmation of technically valid submission of the dossier via the Gateway or the Web Client, the applicant has to send the application electronically to all rapporteurs and co-rapporteurs. If CD-ROM or DVD are used, they have to be sent at the same time to the PA-BUS and to the (co-)rapporteurs who will have the data media when the EMA confirms the validation. This helps avoiding delays.
•Validation of the application: In simple words, validation of the application dossier means the confirmation of completeness and compliance to certain standards. In the event that the EMA requires additional information to complete the validation, it will contact the applicant and request the missing information within a specific time limit. The applicant may exceed the deadline up to 2 months. If the Agency receives no response within 2 months, the application procedure will be closed. The applicant has to send his/ her response within the deadline to the EMA and a copy to the (co-)rapporteurs.
•Submission requirements for the other Committee members: After validation of the application, the Agency will notify both the applicant and the (co-)rapporteurs accordingly in writing. After that, the applicant should forthwith send the application as well as all additional submitted information to the members of other Committees (i.e. Pharmacovigilance Risk Assessment Committee, PRAC, or the Committee for Advanced Therapies, CAT). For this, EMA's Guideline entitled "Dossier requirements for Centrally Authorised Products (CAPs)" from 5 November 2013 has to be considered.
All important requirements about the electronical submission of application dossiers can be found on EMA's eSubmission webpage. “如何以及向谁，我会提出我的档案？ ” - 这个问题是EMA的问答上的集中审批程序（ “预授权程序的咨询的集中过程的用户” ; EMA/339324/2007 ）的情况下程序问题的文件否28。要回答这个问题， 2013年12月进行了更新，并介绍了方法来提交在集中过程的上下文中的电子化格式的卷宗（自2010年1月1日，所有提交的论文已被否决） 。答案包含对文件和已还最近更新的指引。

在下面，你会发现每章一个简短的摘要：
•语言：英语只有接受。
•格式：的eCTD是唯一可以接受的格式。最新的电子化标准和规范（展位： 2013年11月）都必须考虑。这些“电子标准法规信息（ ESTRI ）的转移”已制定了非物质文化遗产的M2专家工作组以及由的eCTD实施工作组（ IWG的eCTD ）得以维持。最新更新涉及模块1 （区域信息）的标准。
•求职信：没有额外的和单独的副本应发送，例如：的CD / DVD光盘，因为他们将创建在处理延迟。
•产品信息（ PI ） ： PI的，必须在两者中的eCTD的模块1 （ PDF格式），并作为独立的文档（ Word格式）中的eCTD结构之外，但在同一eSubmission网关提交。
•活性物质主文件（ ASMF ） ：申请人必须确保ASMF （ “关闭”部分）尽快提交ASMF持有人。
•提交到均线：该档案应通过eSubmission网关或eSubmission Web客户端提交。附加提交的CD- ROM或DVD的导致了应用程序的处理延迟。谁尚未使用的网关或Web客户端（即因技术原因）申请人应递交申请如CD -ROM或DVD的EMA （ PA- BUS的产品及应用业务支持的注意，见Q＆A文档详细地址） 。
•提交的要求对不同的委员会（联合）报告员：接收技术上有效提交卷宗经由网关或Web客户端的确认后，申请人有权以电子方式发送给应用程序的所有报告员和联合报告员。如果CD-ROM或DVD时，他们在同一时间发送给PA - BUS和到（合作）报告员谁都会有数据媒体时均线确认了验证。这有助于避免延误。
•应用程序的验证：简单地说，在申报资料的验证手段完备，并遵守一定的标准的确认。在该均线需要额外的信息来完成验证的事件，它会与申请人联络，并请求一个特定的时间内丢失的信息。申请人可能超过期限长达2个月。如果原子能机构收到2个月内没有响应，应用程序将被关闭。申请人必须在限期内送他/她的回应均线和副本送交（合）报告员。
•提交要求的其他委员会成员：应用程序的验证后，该机构将通知申请人和（合）报告员据此以书面形式。在此之后，申请人应立即将有关该应用程序以及所有附加信息提交给其他委员会的成员（即药物安全风险评估委员会， PRAC或委员会先进的治疗方法， CAT） 。对于这一点， EMA的指引有权从2013年11月5日已被认为是“为集中审批上市产品卷宗的要求（ CAPS） ” 。
所有关于电子化提交申报资料的重要要求，可在EMA的eSubmission网页上找到。