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.
Digital Application Dataset Integration (DADI) Network Project Webinar 18/01/2022 – Live broadcast available
In a previous news published on 10 December 2021 EMA announced the upcoming webinar ”Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms” on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session. The updated guidance enters into force 1st February 2022.
At certain points throughout this session, participants will be able to ask questions and give their input via the audience interaction tool Slido. Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido
Kindly note the session will also be recorded and made available through EMA Corporate Website.
Thank you for forwarding this message to your affiliated Members who wish to participate.
Updated EU Harmonised technical eCTD guidance now available
An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available here. The updated guidance enters into force 1st February 2022.
Final, updated Veterinary eSubmission Guideline and other relevant veterinary eSubmission documents are now available
An updated version of the Veterinary eSubmission Guideline and other relevant veterinary eSubmission documents updated to reflect the VMP-Reg are now available here.
The EMA is closed 23 December 2021 to 3 January 2022 inclusive.
The EMA IT service desk closes at 18:30 (CET) on 22 December 2021.
A skeleton service will be available on 23rd, 27th, 28th, 29th, 30th and 31st (half day) December 2021, as well as on 3rd January 2022.
Please note that if the queries are complex or require specific expertise they may not be resolved until the service desk returns to normal service on 4 January 2022.
There will be no regulatory procedural support available during the EMA office closure.
We would like to advise to send all planned in December submission in timely manner considering limited availability of IT service desk during upcoming Christmas holiday.
Invitation to register to the Digital Application Dataset Integration (DADI) Network Project Webinars
The Digital Application Dataset Integration (DADI) Network Project to replace electronic application forms is pleased to announce it's first public webinars which will take place on 18 January 2022, h. 10:30-12:00 Central European Time (CET) and on 25 January 2022, h. 10:30-12:00 Central European Time (CET).
New version 188.8.131.52 of all eAFs is now available on the eAF website. The forms for human applications (maa, variation and renewal) are ready for immediate use. The use of the v184.108.40.206 for human procedures becomes mandatory after a short one-month transitional period on 1st January 2022. The version v220.127.116.11 of the human forms has been removed from the eAF website, however users can continue to submit applications using this version until the end of December 2021.
The main change in this version of the forms for human use relate to the mandatory use of OMS for Centralised Procedure applications. This version of the forms removes the free text fields in the forms when EU authorisation/Centralised Procedure is selected. Additionally, a bug fix relating to Medical Device section in the variation form has been provided.
The forms for veterinary applications are available for applicants and MAHs to familiarise with the updated forms prior to the mandatory use of this version for veterinary submissions from 28th of January 2022. Please note that there will be no transitional period once these forms go-live on the 28th of January. The v18.104.22.168 cannot be used for any new procedures starting after 28th January 2022.
The main changes in this version of the veterinary forms (maa and variation) relate to the implementation of the Regulation (EU) 2019/6 for Veterinary Medicinal Products.
The version 22.214.171.124 cannot be used for procedures prior to 28th January 2022, however, in the view of significant changes in the forms it is strongly recommended that applicants will carefully review the form prior to the mandatory use deadline in order to identify and report any issues in the implementation and thus allowing an opportunity to fix any issues found prior to 28th January 2022.
The version 126.96.36.199 will remain available for use for veterinary procedures (maa and variation) until the mandatory use of v188.8.131.52.
More details can be found from the release notes and the technical documentation available here.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022, it is important to note that the version of the form must not be changed during an ongoing procedure.
For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.
Essential maintenance to PSUR and eSubmission Gateway
Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.