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Human eSubmission
eCTD v3.2
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

eSignatures

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Introduction

To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.

For details on how to find us please click here.

eSubmission eAFRSS news feed


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What's New in eSubmission Today?

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10-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) is now available. The release v1.23.1.3 is a bug fix release to correct number of issues that affect the forms. Further details are available in the release notes available here. This bug fix release does not affect the Data Exchange Standard (DES).

09-10-2019

Formatted Table Template implementation in the XML delivery files – now live

A new version of the eSubmission Gateway XML delivery file user interface is now available.

Following this release the use of the Formatted Letter template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to provide the Formatted template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.

From 1 January 2020, the Formatted Letter Template will no longer be maintained by EMA. The document and references will be removed from EMA corporate website.

Users are required to fill in all the submissions attributes correctly through eSubmission Delivery File UI by creating an XML delivery file since all attributes in the XML delivery file are used to support important searches in Common Repository. The use of XML delivery files will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release will not work following the deployment of the new version. It is always recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.

The changes are detailed in the release notes here.

Updated version of the PSUR Repository

Updated versions of the PSUR Repository Industry and NCA User Interfaces are now available. There are minor changes to the system and are detailed in the release notes here.

07-10-2019

Essential maintenance to computer applications on Wednesday 09-10-2019

PSUR and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST) on Wednesday, 9
October 2019. However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.  If you have any questions, please contact the IT Service Desk.

01-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) will be available 10 October 2019. The release v1.23.1.3 is a bug fix release to correct a number of issues affecting the forms. More details on the fixes will be available in the release notes which will be published together with the updated forms. This hotfix release does not affect the Data Exchange Standard (DES).
Updated Release Milestone Plan for eAF and updated Release schedule for eAF and CESSP are available here
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25-09-2019

Formatted Table Template implementation in the XML delivery files

An updated version of the eSubmission Gateway XML delivery file user interface will be made available in early October 2019.

Following this release the use of the Formatted Letter Template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and after this it will be optional for applicants to provide the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.

From 1 January 2020, the Formatted Letter Template will no longer be maintained by EMA and the document and references will be removed from EMA corporate website.

Users are required to fill in all the submissions attributes correctly through eSubmission Web UI by creating an XML delivery file, since all attributes in the XML delivery file are used to support important searches in Common Repository. The use of XML delivery files will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release will not work following the deployment of the new version. It is always recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated system release notes detailing the changes will be made available at the time of the release.

And

Updated version of the PSUR Repository

An updated version of the PSUR Repository Industry and NCA User Interfaces will also be made available in conjunction with the new release of the eSubmission Gateway Delivery file UI. There are very minor changes to the system and these changes will be detailed in the release notes which will be published at the time of the release.

16-09-2019

The ICH M8 Vendor Readiness Survey is now closed. More information on eCTD v4.0 can be found here.

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Weekend maintenance to most EMA computer applications during the weekend of 21st – 22nd September 2019.

Users should be aware that due to essential maintenance work on Oracle databases, most of EMA’s computer applications will experience downtime between the hours of 18.00 on Friday, 20 September and 06.00 on Monday, 23 September 2019.

If you have any questions, please contact the IT service desk.

10-09-2019

Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The current planning in the new version of the eSubmission Roadmap that was recently adopted by HMA currently says that the CESP dataset module will be live for all procedures before the end of 2021 and then becomes mandatory 6 months after.

Relevant documents, i.e. VNeeS guideline and VNeeS checker tool will be updated and published 6 months before mandatory use of PDF/A.

09-08-2019

Vendor Readiness Survey 

The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.

More information about eCTD v4.0 including the EU IG package can be found here.

Updated reminder on the working documents provided within the eCTD submissions

As per the structure of the eCTD, the product information should be provided in PDF format within Module 1.1.3. However, occasionally it is necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate folder called xxxx-workingdocuments on the same submission zip package as the eCTD.

For PMF certification submissions the ePMF should be provided within the working documents folder. This folder should be called “xxxx-workingdocuments” as for all other documents.
Other documents that can be provided as working documents outside of the eCTD structure include for example the RMP, (validation) checklists or any document specifically requested to be provided as a working document by the Health Authorities.

Please note: the Agency strongly recommends that applicants only include as part of the working documents folder applicable documents. Providing additional documents e.g. entire modules will cause delays in processing the application.

Please note: the eCTD validation report should not be included in the working documents folder. More information on the working documents can be found from the Harmonised Technical Guidance for eCTD Submissions in the EU.

 

Previous news is available here

 

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