News
21-12-2022
Updated PLM Portal eAF timeline now available
Please find an updated version of the PLM Portal eAF (DADI) Human Variations Forms timeline. The slide is also available on the the PLM Portal Forum.
And
Updated PLM Portal Guide to eAF (DADI) Registration is now available
An updated version of the Portal (eAF) guide to registration is now available also on the PLM Portal Forum. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes several updates across the document.
13-12-2022
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to the web eAF made in the version 1.0.1.3 released to production on 12th December 2022 are now available on the the PLM Portal Forum and below.
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Update on PLM Portal eAF (DADI) 2023 UAT and releases
Following the launch of the web-based Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the
Product Lifecycle Management (PLM) Portal, users have accessed the PLM Portal to work on variation applications using the new web-form. This is a valuable step for users to familiarise themselves with the system as well as for the development team to gain more insights on features to improve and issues to fix.
The development team's priority now is addressing issues in the web form and stabilising it. Following this, work will continue adding the data and functionalities needed to fully support national, MRP and DCP variations application procedures and submissions.
EMA has therefore decided that the previously planned industry external User Acceptance Test (UAT) in January 2023 will be rescheduled to a date expected to be announced in the first half of 2023. The UAT will be scheduled when there are meaningful new features and capabilities to be tested.
To support stakeholders' planning for possible participation in the UAT and anticipate eventual transition to the use of the web-forms please note the following:
- The target window for introducing Nationally Authorised Medicinal Products (all NAPs, including MRP/DCP) to the variation application form is now Q2 2023;
- In addition, further capabilitiesneed to be introduced to make the variations eAF ready to start a formal transition period, the target window for release of these features is Q2-Q3 2023
- More precise time windows will be shared in the first half of 2023 with the aim of providing a minimum of a 2-month lead time before the UAT or a major release
For more insight on eAF, you can use the following resources:
06-12-2022
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to the portal made in releases on 14th November 2022 and on 28th November 2022 are now available on the PLM Portal Forum and below.
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Note on production release on 14th November 2022 on the PLM Portal eAF
As part of EMA's regular biweekly release schedule, a minor release including number of bug fixes and other changes went live on 14 November 2022.
This release was not announced in advance on the PLM Portal Forum in the manner the production team would usually aim to communicate. The procedure for the announcements and information for releases - major and minor - will be reviewed to ensure their timely provision.
No release notes were shared at the time of this release, however, the Release notes have now been updated and they are now available in the PLM Portal Forum and below under the PLM Portal eAF (DADI) documentation.
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Please share any questions with us via eSubProgofficer@ema.europa.eu.
17-11-2022
Updated PLM Portal Guide to eAF (DADI) Registration is now available
An updated version of the Portal (eAF) guide to registration is now available. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes further details on the use of Multi Factor Authentication (MFA).
Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields.
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Please share any questions with us via eSubProgofficer@ema.europa.eu.
04-11-2022
Web-based Human Variations eAF (DADI) now live on the new Product Lifecycle Management Portal
EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) is now available on the new Product Lifecycle Management (PLM) Portal. This is a big, first milestone in the ongoing journey to improve the eAFs and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other web-based forms.
Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields.
As a reminder: the use of the new web-based form is optional. This release will not trigger a transition period towards mandatory use. The formal transition period will start when nationally authorised products (NAPs) and features supporting use cases covered will be added to the form. The current interactive PDF eAF will remain available until the end of the transition period.
The new PLM Portal will in due course host all eAFs. In the future it will also host the data input user interface for product management service (PMS) data and the interface to provide data for for electronic Product Information (ePI). The PLM Portal will develop over time to inform and support you in the use of these services. One new feature launched on the PLM portal is a chatbot through which you can ask questions about the web-forms and get quick answers.
14-07-2022
eAF Portal Guide to Registration v1 released
The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration.
The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Invitation to register to the DADI eAF training and Q&A webinars
The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient.
The variations form for Human medicinal products will be the first form to be released by DADI in October 2022. To effectively support stakeholders ahead of the go-live date, EMA is pleased to announce two new public eAF training and Q&A webinars.
- 1st eAF training and Q&A webinar: 26 July 2022, 11:00-12:30 Central European Time (CET) - Registration link
- 2nd eAF training and Q&A webinar: 2 September 2022, 11:00-12:30 Central European Time (CET) - Registration link
These events are training webinars for industry and national competent authorities' stakeholders wishing to learn more about access management aspects related to the new eAF dedicated portal and the procedure to fill in a web-based eAF at go-live.
During the sessions, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal, how to fill in the web-based eAF, select products and export the forms.
Kindly note recordings from both training sessions will be made available after each event.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
07-07-2022
DADI Human Variations eAF User Acceptance Testing (UAT) - Call for Volunteers
In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the European Medicines Agency (EMA) is pleased to invite Applicants to participate in the User Acceptance Testing (UAT) phase of the Digital Application Dataset Integration (DADI) Network project.
UAT timeline and scope
The DADI UAT is planned to be conducted between 5 September and 16 September 2022. During that period, the production-like version of the electronic Application Forms (eAF) Portal will be open for testing. As recently communicated, please note that the scope of this UAT is limited to Centrally Authorised Products (CAPs). The UAT participants are expected to perform testing activities, by filling in electronic Application Forms as close as possible to real-life scenarios. Namely, this implies filling in an eAF for one or multiple CAPs, single scope or grouping of scopes from different variation procedure types (e.g., type IA or type II), and to export the PDF output to be included in a submission.
Information about training/troubleshooting material and sessions
If you would like to participate in the DADI UAT you are kindly asked to, as pre-requisites: (i) have an active EMA user account, and, (ii) request the necessary user access role(s), both via the EMA Account Management portal. A user guide will be provided.
Please note that prior to the DADI UAT, training/troubleshooting material and sessions will be provided to prepare the UAT participants to the maximum extent possible, thereby avoiding potential unnecessary problems that may occur during the UAT phase (e.g., registration process, access management, etc.).
A UAT kick-off session is planned for 5 September 2022.
The following two access management troubleshooting sessions are scheduled:
- First access management troubleshooting session: Thursday, 21 July 2022
- Second access management troubleshooting session: Tuesday, 23 August 2022.
The above-mentioned sessions aim to be a hands-on guide for testers to create an EMA user account and request user access role(s). Attendance to the sessions is optional: you may be interested in attending one out of the two access management troubleshooting sessions in case of issues with access management.
In addition, two public training and Q&A webinars are scheduled:
- First training and Q&A webinar: Tuesday, 26 July 2022
- Second training and Q&A webinar: Friday, 2 September 2022.
The EMA will make available the training materials and provide more details on how to attend the scheduled sessions in due course.
Information about reporting findings/bugs
Only consolidated feedback is expected to be reported to the EMA by a limited number of users (coordinators), who will be granted access to Azure DevOps, the EMA’s platform for bug reporting purposes.
You are kindly requested to report your bugs/findings directly to your Industry Association. The following Industry Associations have been shortlisted to collect your feedback:
- AESGP
- EFPIA
- Europharm
- EuropaBio
- Medicines for Europe
- Vaccines Europe
Please directly contact your respective Industry Association to liaise on the practicalities for reporting a bug/finding. Please note that the number of participants to the UAT is limited.
If you are not a member of an Industry Association, i.e., for example, you represent a consultancy, please check with the company you represent if they can grant you access in IAM and if you can report the findings through the Industry Association they belong to.
Next steps
Please inform the EMA at your earliest convenience, whether you would like to participate in the DADI UAT to test the eAF platform.
We look forward to receiving your feedback, by writing to eAF-testing@ema.europa.eu (cc: industry@ema.europa.eu) at the latest by 15th July 2022, with the following information (for each organisation):
- First name, last name, and e-mail address of members interested in participating to the UAT
- Name of your organisation and, if already available, OMS Location ID
- Name of the Industry Association to which you aim to report findings/bugs (if/when applicable)
After the call for interest deadline you will receive a communication informing you if you have been selected to participate to the UAT.
For further information please see a presentation including the DADI UAT timeline.
05-07-2022
DADI Project Human Variations revised go-live scope
EMA will launch the eAF variations web form in October 2022. This is a first release of the web-based variation form for human medicinal products that will be improved and expanded in subsequent releases in 2023. This progressive release model follows the Agile development model of the Agency.
The scope of the October 2022 go-live will be limited to Centrally Authorised Products (CAPs). EMA made this decision due to the complexity in synchronisation of the data between xEVMPD and PMS. At this initial release of the form the available data for CAPs is coming from EMA internal database and it is the same dataset currently used in IRIS to support Inspections.
This version of the form cannot yet be used for applications containing Nationally Authorised Products (NAPs), including National Procedures, Mutual Recognition Procedure and Decentralised Procedure.
A subsequent release of the form in March 2023 will support all types of EU variation procedures (CAPs and NAPs).
The timeline describing updated release schedule reflecting the revised dates for subsequent releases is available here.
We appreciate you may have questions about this change of scope. To help address these we are offering:
- A Q&A webinar on 12 July, 11:00-12:30 Central European Time (CET) (Please use this Registration link to register to join this Q&A session).
- An update to chapter 7 of the EU Implementation Guide for ISO IDMP covering details of what a CAPs only go-live will mean which will be published soon.
- A DADI Q&A document around what will happen at go-live which will be published before end of July 2022.
06-10-2020
The eSubmission Roadmap describes an initiative called Common European
Single submission Portal which was due to deliver a single submission channel for all
European submissions with integrated application forms. The delivery was planned in
multiple phases. The first phase was to deliver web-based application forms for initial
Marketing Authorisations for Human and Veterinary domains. These forms were to be followed
by subsequent releases of variation and renewal forms and finally, an integration of the
eSubmission Gateway and the CESP Delivery Portal.
The CESSP Phase 1 project was expected to deliver the application forms for initial
Marketing Authorisations for Human and Veterinary as a replacement of the EMA hosted
PDF format electronic Application Forms (eAFs). However, the project has faced
implementation challenges and budgetary constraints and a decision has been taken
to close this project.
Please notice that stopping CESSP Phase 1 does not affect operation and maintenance of the CESP delivery portal.
More details on the next steps will be provided on the
eSubmission website as soon they are approved by the relevant governance bodies.
The project team would like to thank everyone who has participated in this project
throughout the years, with dedication and great input, and we would like to assure
you that we will pass on the results already achieved to see how they can be useful in
the future approach.
11-03-2020
The milestones for the CESSP phase 1 project have been updated and can be found below.
05-06-2019
The milestones for the CESSP phase 1 project have been updated and can be found below.
03-06-2019
A webinar providing an update of the CESSP phase 1 project (converting the current eAFs MAA human and veterinary into web based forms) will be held on 5 June 2019. This webinar is aimed for Regulators and instructions on how to connect have been sent out by email to representatives of National Competent Authorities.
23-05-2019
The presentation and recording from the webinar providing an update to Industry about the CESSP phase 1 project held on 7th May 2019 is now available. Questions and answers from the webinar will be added to the CESSP Q&A document.
15-04-2019
A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.
Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual meeting room is limited to 200 participants. If multiple users from your organisation are attending, please share the connection with your colleagues.
The webinar will be recorded and the recording will be made available on the CESSP webpage after the webinar.
How to login is availble here.
10-04-2019
The slides from the CESSP XML schema training held by the Network Training Centre are now available.
15-03-2019
The final draft versions of the new XML schemas for the human and veterinary MAA forms that will be used in CESSP phase 1 are now available. Please provide your comments on the XSDs to cesspproject@hma.eu by 30th of April 2019.
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The Network Training Centre is organising a webinar on utilising the upgraded XML schema of the initial application forms (eAF MAA human and Vet) to automate application data import into IT systems. The session will be held on 27th March 2019 at 10.30am CET. All relevant NCA staff is encouraged to register for the training on the NTC platform here.
Relevant documentation
Contact us: cesspproject@hma.eu
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