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eSubmission Gateway

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eCTD

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eCTD v4.0

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UPDATE

In order to perform essential system maintenance, the EMA Gateway will be unavailable until further notice.

The deadline for submissions due by close of business on 30 September 2016 will be extended to allow at least 24 hours following restoration of the service for submission of files due. The submission deadline will be at the earliest on Monday 3rd of October 2016 23:59 UK time.

The new validation rules (v6.1of eCTD validation criteria) will be implemented with effect from the same time as the deadline for submissions noted above. Thus all submissions due by 30 September will be validated using v5.1 of eCTD validation criteria, and all submissions received after the extended submission deadline will be validated using v6.1of eCTD validation criteria. The same applies to NeeS format submissions where relevant.



Introduction

For human medicinal products in the context of the International Conference on Harmonisation (“ICH”) , an electronic exchange standard for the submission of regulatory information by applicants for marketing authorisations for medicinal products to the relevant competent authorities has been developed.

Based on the ICH Common Technical Document (CTD), the ICH M2 Expert Working Group has developed the electronic CTD (eCTD) Specification and released version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and completes it with the European Module 1.

In addition to the continued development and maintenance of the electronic submission standards, and in order properly to implement the eCTD from the perspective of the EMA and National Competent Authorities, there are a number of prerequisites. These include development of the necessary business processes to receive and handle electronic submissions (particularly the eCTD); development of policies particularly those with regard to electronic archiving; and development and implementation of an appropriate technical infrastructure and implementation of systems. Most notable here is the requirement for a tool that will enable Competent Authorities that choose to implement it to receive, validate, store and make available for review marketing authorisation applications and supporting documents submitted electronically by applicants using the eCTD (commonly known as the European Review System or EURS).

For veterinary medicinal products, esubmission guidance has also been developed.

These different initiatives can be encompassed within the general term 'electronic submission implementation'.

All comments and feedback on the content of this website should be sent to esubmission@ema.europa.eu.

 

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What's New in eSubmission Today?

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01-10-2016

The use of the updated EU Module 1 Specification v3.0 and/or v3.0.1 is now mandatory for all eCTD format submissions in the EU. The specification and related documents are available here.

The use of the XML delivery files for submissions via the eSubmission Gateway and the Web Client is now mandatory. The use of XML delivery files has replaced the use of filenaming conventions for majority of human and veterinary submissions to the EMA. More information on the use of the delivery files for submissions via the eSubmission Gateway and the Web Client is available here. The Annexes describing the filenaming conventions have been updated.

Applicants are reminded that the section 2 of the electronic Application Form (eAF) should be filled in. The use of the footnote is only allowed for form and strength information for complex vaccines/combination products. The eAFs and related user guides are available here.

Applicants are reminded that eCTD validation reports must not be provided in the working documents folder in the submissions to EMA. More information on the use of the working documents folder is available in the Harmonised Technical Guidance for eCTD Submissions in the EU document.

19-09-2016

A further update to the revised Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions is available here.

The use of the eAF v1.20 will become mandatory on Monday 19th September 2016. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure. The latest version of the forms and relevant guidance is available here.

Essential maintenance to PSUR Repository and the eSubmission Gateway on Tuesday evening 20th September 2016

Please note that the PSUR Repository will be unavailable for Member State and industry users between 18.00-19.00hrs UK time on Tuesday, 20th September due to essential maintenance.  The EMA eSubmission Gateway/Web Client will not be available during this time.

 If you have any questions or issues, please contact the EMA IT Service Desk

19-08-2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.2) have been published following reported issues. The updated forms and related release notes are now available here. Version 1.20 of the forms has been available for use since 14th June 2016 and will fully replace version eAF v. 01.19 after an extended transitional period on19 August 2016. Version 1.19 of the forms may be used until 18 September 2016.

18-08-2016

Recordings from the webinar training on the use of the updated XML delivery files for submissions via the eSubmission Gateway held on 21st July and the interactive Q&A sessions held on 25 and 26th July are now available here.

The recording of the PSUR Repository v1.07 webinar training held on 25 July and recordings from the webinars on the Mandatory use are now available here.

 

 

Previous news is available here

 

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