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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 Delivery

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 Dataset Module (AF)

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

Previous news is available here

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What's New in eSubmission Today?

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26-11-20202

eAF issue with webservices

An issue relating to the eAF webservice update has affected availability of terms in the ‘Pharmaceutical Form’ field in all 4 forms. We have released a fix that has partially solved the issue; however, we are aware that there are still many combined pharmaceutical forms that are currently unavailable in the eAFs. Please note that as this issue affects the webservices to the form, not the form itself, also previous versions of the form are affected. We are working on a further fix to solve this issue as soon as possible.

For any issues with the eAFs, please raise a call via the EMA service desk.

19-11-2020

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


An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced multiple changes ranging from new fields to changing previously optional fields to mandatory fields and a major change for Paediatric submissions by completely transforming the delivery files for these types of submissions as we are preparing to extend the Common Repository to contain Paediatric submissions.

Details on the changes are described in the release specific presentations, the updated user guide and the updated release notes which can be found here and specific details relating to the Paediatric delivery files can be found here.

Users should note that the delivery files created prior to the new release will not work after the go live.

27-10-2020

eAF v1.24.0.0 important note to users

An updated version of the variation eAF v1.24.0.0 is now available on the eAF website. This release which does not change the form version number, provides a fix to the Adobe backwards compatibility issue and it should solve the issues some users have experienced with the scope selection dropdown list in section 3. This version also includes a change in the form validation rules for grouping of Type IA or Type IAIN variations.

Please ensure that upon opening the eAF you ‘trust’ the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu’s will not work if the form has not been trusted.

The Presentations for applicants and NCAs on the release v1.24.0.0 have been updated and are available here.

For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.

 

 

05-10-2020

The Guideline on eSubmission for Veterinary products - version 2.7 entered into force on 01 October 2020.

29-09-2020

The EU Change Control Process

The EU Change Control Process for Veterinary has been updated and can be found here.

15-09-2020

eAF v1.24.0.0 now available


Version 1.24.0.0 of all four electronic Application Forms (eAFs) is now available. The release v1.24.0.0 provides a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). Some defects have been fixed in MAA human, MAA vet and renewal (H&V forms.

The new version is implemented with 3 months transitional period. Mandatory use of v1.24.0.0 will start on 16th December 2020.

More details can be found from the release notes and the updated Practical user guide for electronic Application Forms as well as the presentation on changes available here.
Please note that due to the major change in the variation form, data imports from older versions of the variation form will not work.

Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

11-09-2020

eAF v1.24.0.0 will be released on 15th September 2020

Version 1.24.0.0 of all four electronic Application Forms (eAFs) will be made available on 15th September 2020 with a slightly longer, 3 months transitional period and mandatory use from December 2020. The release v1.24.0.0 will provide a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). There has been minor defect fixes in the other 3 forms (MAA human, MAA vet and renewal (H&V).

We would like to thank all UAT participants for your efforts and very useful comments.

A slightly updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available.

04-09-2020

Issue with eSubmission Gateway and its infrastructure

For the last few days, the  EMA Gateway and surrounding infrastructure experienced an unplanned outage. 
This has resulted in delays in acknowledgment communication as well as internal delays in submissions distribution.

The service is now available but we request you do not resubmit packages as the process of sending acknowledgments is experiencing delays.
Thank you for your patience and understanding.

20-07-2020
eAF v1.24.0.0 - Updated UAT details, updated release milestone plan and updated release schedule for eAF now available


An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available.

Version 1.24.0.0 of all the 4 electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 month transitional period, and mandatory use from November 2020.
The release v1.24.0.0 will provide a major change into the section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation).

Please note that both MAA forms, human and veterinary, have been added into this release following a discovery of a defect in the forms.


The User Acceptance Testing (UAT) to support the release of this next version of the forms started on Friday 17th of July 2020.

Due to the delay in starting testing, we are now testing in parallel with both user groups (Industry and NCAs) and the UAT will run until Tuesday 4th of August 2020.
If you have not yet registered, however, wish to participate in the UAT, please contact us by email to eSubprogofficer@ema.europa.eu 

 

 

 

EMA
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