|
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.
 RSS news feed
Previous news is available here
|
|
07-12-2023
Updated eAF v1.26.0.0 (Human MAA) and v1.26.0.1 (Vet MAA) now available
Updated v1.26.0.0 Human MAA eAF is now available on the eAF website. The form is ready for immediate use. The change implemented in this version is a minor bug fix (related to Annex 5.19).
It is strongly recommended to use this latest version (document properties date 27.10.2023). Please note that there is no version number change and that the release notes are published in the relevant section of the eAF webpage.
Updated v1.26.0.1 Vet MAA eAF is now available for immediate use.
The changes in this version relate to label and text changes only. Additionally, the version number has updated from v1.26.0.0 to v1.26.0.1.
The version 1.26.0.1 can be used immediately, and it is strongly recommended that it will be used for all new applications as soon as possible, however, the one-month transitional period will run until 8th of January 2024 after which the use of version 1.26.0.1 for the Veterinary MAA form will become mandatory.
The version 1.26.0.0 has now been removed from the eAF website however users can continue to submit applications using this version until 7th of January 2024.
Please note that as there are no technical changes, it is possible to import the xml from version 1.26.0.0 into version 1.26.0.1 to avoid any need for manual effort.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure, please note that if you need to provide an updated form for a procedure that has started prior to 8th of January, you should use the previous version.
Updated release notes are published in the relevant sections of the eAF webpage.
05-12-2023
Survey for eSubmission website (open until Monday, 18 December 2023)
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the eSubmission website.
By completing this short 2-3 minutes survey, you help us to understand if the website addresses your user needs.
May we kindly ask you to complete this survey by Monday, December 18th? The link to the survey can be found here: eSubmission User Survey.
We highly appreciate your input.
And
05-12-2023
Survey for PSUR Repository (open until Monday, 18 December 2023)
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the PSUR Repository.
By completing this short 2-3 minutes survey, you help us understand if the application addresses your user needs.
May we kindly ask you to complete this survey by Monday, December 18th? The link to the survey can be found here: PSUR Repository User Survey.
We highly appreciate your input.
01-12-2023
New submission unit to be used for requesting a Re-examination of an CHMP Opinion
An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 1 December 2023, 18:00 CET. This update introduces in the delivery file for Human submissions the option to choose "Re-examination" submission unit for various submission types. Use this unit for requesting re-examination of opinion for MAA, extension, Type II variation, renewal and annual re-assessment as well as Referral procedures
Please note that regulatory guidance referring to how to send re-examination requests will be updated in the following period. Re-examination requests should be submitted via the eSubmission (Syncplicity) Gateway using eCTD format where required for the procedure type.
30-11-2023
Updated version of the eAF v1.26.0.0 (variation and renewal)
An updated version 1.26.0.0 of the Variation and Renewal (both Human and Veterinary) eAF is available starting with 28 November 2023, 18:00 CET.
A change has been implemented to allow Non-Current terms to be selected in the "Pharmaceutiacal form" lists.
It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes were updated and published in the relevant section of the eAF page.
28-11-2023
eCTD EU Module 1 Specification proposed changes now open for public consultation (Deadline: 12 January 2024)
The Human Harmonisation Group has analysed the change requests received upon opening the eCTD EU Module 1 Specification for review and is now publishing the draft documents for public consultation:
The eCTD EU Module 1 Specification contains a summary of the proposed changes in the Document control table, and all the amendments are highlighted throughout the text with the track changes feature.
The eCTD EU Validation Criteria contains a summary of the proposed changes in the Document control tab.
Please submit your questions and comments via email to EUM1Spec@ema.europa.eu by the end of the day 12 January 2024.
After consolidating the public comments, the final versions of the documents and all the relevant files (including the Release notes, Package, Checksums) will be published on the eSubmission website. The date of entering into force will be announced at the time of the publication and will allow 9 months for the implementation of the changes.
28-11-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.12 released to production on 27 November 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
20-11-2023
Invitation to register for the Product Lifecycle Management Value Stream Deep-Dive Webinar, 30/11/23 h. 14:00-16:00 (CET)
EMA is pleased to announce a public webinar (event page on EMA website) for medicines developers and regulators eager to gain deeper insights into what the Agency's Product Lifecycle Management (PLM) value stream is working on and its goals. The event will take place on 30 November, 14:00 - 16:00 (CET).
This webinar aims to show the interconnections between the various digital products being delivered. In addition, it will outline the approach taken to enhance product lifecycle management technology to enable more efficient and effective medicine regulation.
About PLM:
PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its Agile transformation. PLM aims to digitally transform and optimise regulatory procedure management as well as data submission and reuse throughout the product lifecycle. The value stream works with EMA partners and stakeholders to deliver systems and services to manage the authorisation and lifecycle of medicinal products and medical devices within the Agency's remit for the ultimate benefit of public and animal health in the EU.
About the Webinar:
During the webinar, the team will share the value stream's vision and roadmap towards a data centric target operating model for end-to-end data capture, processing and re-use, as well as how PLM's products and solutions contribute to this vision.
Featured PLM Products and Solutions:
- Solutions for Human & Veterinary medicinal products:
- Solutions for Human medicinal products:
- Solutions for Veterinary medicinal products:
What's in it for you:
This webinar presents a valuable opportunity to enhance your understanding of the work of the value stream and stay informed about the latest developments in this area, ask questions and interact with the responsible EMA teams.
Registration & Contact details:
Interested stakeholders are invited to kindly register at the following link.
Please note registration will remain open until the start of the webinar.
You have the opportunity to send your questions in advance via Slido.com using the specific event code: #PLMVS-QA.
Should you have any questions or require further information, please feel free to contact us at plm.valuestream@ema.europa.eu.
14-11-2023
Updated PLM Portal eAF FHIR XML Release notes now available
An updated version of the PLM Portal eAF FHIR XML Release notes reflecting the implementation of FHIR XML 1.2.0 in the PLM Portal eAF (to be released to production on 21 November 2023) are now available on PLM Portal Forum
23-10-2023
Updated VNeeS checker for v3.1 now available
An updated version of the VNeeS checker provided by Anses - ANMV is now available here
19-10-2023
Updated variation Conceptual Data Model
The conceptual data model for the variation form has been updated and is now available here
06-10-2023
Updated version of the VNeeS specification v3.1 now available
The guideline on eSubmissions for Veterinary products version 3.1 has now been published. It will enter into force on 1 November 2023 (see links under section “Current Guidance”).
The update is related to a best practice criterion in the technical validation checklist for the additional information folder (“add-info”). In case you will be using a checker tool not yet aligned with this new best practice requirement, for relevant submissions like SRPs, in case of doubt, we recommend to verify the path length in the add-info folder with the publicly available VNeeS checker tool to avoid potential technical blocks during dossier upload and thus circumvent the need for last minute changes of your submission.
06-10-2023
eSubmission Gateway XML delivery file update for Article 18 submissions
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Human submissions (option to choose Article 18 as submission type).
The details on the changes will soon be provided in the updated release notes and the updated user guide. More information on Article 18 can be found
here.
05-10-2023
Update on web-based electronic Application Forms (eAFs) implementation
The electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with a comprehensive update on the progress of the web-based Human variations eAF implementation on Product Lifecycle Management (PLM) Portal.
The following milestones are now for Q1 2024:
- Release of split* (i.e. IDMP compliant) Centrally Authorised Products (CAPs) for use in the variations eAF;
Release National Authorised Products (NAPs) for use into the Human variations eAF;
Introduction of the Product Data Management User Interface (UI), offering users seamless access to view their product data available in the Product Management Services (PMS) database.
As we advance, we remain committed to transparency and will provide a comprehensive update on these targets at the end of Q4 2023, evaluating the quality of both the system and available data.
Currently, our primary focus is ensuring quality of data and system's performance to prepare a transition-ready version of the web-based Human variations eAF. To begin the transition phase towards mandatory use of web-based Human variations eAFs, the following key steps are required:
- Implementation of missing features.
- Resolving pending issues that prevent users from completing a form.
- Releasing all products (NAPs and split* (i.e. IDMP compliant) CAPs) from the Product Management System (PMS) to the PLM portal in the production environment.
- Capability to keep PMS data synchronised with existing databases.
- Ensuring system stability.
As previously committed, any announcement concerning the starting date of the formal transition period will follow User Acceptance Testing (UAT) of the system and the subsequent addressing of any critical issues. This is explained in this slide.
The primary objective remains to implement web replacements of interactive PDF eAFs, enabling user-friendly capture and handling of variations, marketing authorisations, and renewals application data for both applicants and regulators. This transition ensures consistency across IT systems and guarantees the availability of high-quality ISO IDMP compliant information.
For further details on the implementation progress and challenges, and the opportunity to ask questions, interested parties are invited to the joint eAF-PMS webinar for 6 November 2023 (13:30 - 15:00 (CEST)). During this session, the eAF team will also demonstrate the anticipated "add package" and "clone application" features that will be released on the PLM Portal for eAF. Please find here the registration link.
We also recommend that anyone with an interest in the development of eAF and PMS watch the relevant sections of the Q3 System Demo recording, available on EMA's website.
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
*CAPs migrated from SIAMED not following ISO IDMP structure. For this reason, they have undergone a further step in the data migration to PMS in addition to the match and merge protocol.
04-10-2023
Updated user guide for the eAF for MAA available on the CMDh website
A new version of the joint EMA/CMDh User guide for the electronic application form for a Marketing Authorisation is available on the CMDh website.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
|
