News
Previous DADI news can be found here
24-04-2024
Register for the Information and Q&A session on updated CAPs in PLM Portal eAF, 7 May 2024
EMA will host an Information and Q&A session on 7 May 2024, 10:00 - 11:00 (CEST) to explain and showcase the changes in the PLM Portal web-based Human Variations eAF after the updated Centrally Authorised Products (CAPs) load. Participants will have the opportunity to ask questions in the last part of the session.
The participation is recommended to Industry stakeholders working on regulatory affairs of their respective organisations.
Register here, and check the event web page for agenda, presentation and recording, all to be published in due time.
23-04-2024
Successful CAPs data load under review, recommended use of interactive PDF extended
Updated Centrally Authorised Products (CAPs) data has been loaded to web-based (PLM Portal) eAF, where users will be able to see this data in their forms.
Please note that, while CAPs data is available as of 16 April, we strongly recommend that no applications using the PLM Portal web-based eAF is used for submissions at the moment. This is due to the fact that the updated CAPs load has impacted how products appear in application forms (e.g., changes to product names, introduction of new medicinal products through splitting, potential alterations to packages, etc.) and some minor adjustments to the functionalities of the web based eAF are needed.
We suggest using the interactive PDF eAF instead of the web-based eAF for submissions to prevent validation issues and potential delays. The EMA will announce the date from which the use of the PLM web-based eAF form can be resumed.
15-03-2024
electronic Application Forms (eAFs) not available for use between 11th and 16th April 2024 due to planned maintenance
Due to planned maintenance activities, the interactive PDF eAFs (human and veterinary variation and MAA forms and the renewal form) and the PLM Portal web-based eAF will be unavailable for use between 11th and 16th April 2024.
Additionally, as announced in December 2023, the PLM Portal web-based eAF will be affected by the data load of Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) into Product Management Service (PMS) as well as the simultaneous load of updated* CAPs to web-based eAF.
This load of data into PMS is a necessary step in preparation to the forthcoming launch of the Product User Interface view and later edit functions as well as making NAPs data available for the PLM Portal web-based eAF.
The data load will take place from 11 to 16 April 2024. During this timeframe, the interactive PDF eAF and the PLM Portal web-based eAF will experience a downtime.
Please note that, during the preparation for the updated* CAPs load in the PLM Portal web-based eAF, the match-merge** operation will result in:
- changes to product names;
- introduction of new medicinal products through splitting**;
- potential alterations to packages.
These changes will impact how products appear in application forms. Therefore, we strongly recommend, with immediate effect, that no applications that might require any update of the eAF, during or after the product upload, are submitted to EMA using the PLM Portal web-based eAF. We strongly recommend to use the interactive pdf eAF instead of the web-based eAF for submissions at least until 26 April 2024 to prevent validation issues and potential delays.
Please note that if you have already submitted a web-based eAF, or it is expected that there will be no need to update the form and/or the procedure will conclude prior to the downtime, you can continue using the web-based eAF.
Please note that, except for the downtime period, the web-based eAF is expected to remain accessible to applicants to familiarise themselves with changes to the products, and for training purposes.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
**The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in EU IG Chapter 7
20-02-2024
PLM Portal eAF and PMS - FAQs and Q&A documents updated
The PLM Portal eAF and PMS teams are pleased to announce that the updated Frequently Asked Questions (FAQs) on eAF and PMS and Questions and Answers (Q&A) Joint eAF and PMS are now available here.
02-02-2024
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 2.0.0 in the PLM Portal eAF (to be released to production on 30 April 2024) are now available on the PLM Portal and in the section of the PLM Portal eAF, Documentation section, together with several documents to provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.0.0 or to start the implementation now with the latest version.
The new version includes the latest official FHIR version “Release #5 (5.0.0): http://hl7.org/fhir/”. This replaces the current version FHIR Release #5: Draft Ballot (4.6.0): http://hl7.org/fhir/2021May/ which will remain online for approximately 3 months to give consuming systems time to adapt to the change.
02-02-2024
User Experience of the current PDF eAFs completion on the PLM Portal
The electronic Application Form (eAF) Product Team would greatly appreciate to receive your feedback on your current experience in terms of time spent in filling in the interactive pdf electronic Application Form (eAF) for Variations for Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), and Initial Marketing Authorisation.
It is acknowledged that different types of procedures (e.g. Type IA, Type II applications, worksharing, and groupings) may require varying time commitments. We would therefore appreciate if, in your answer, you could provide the average time spent and resources used to fill in the forms.
Your feedback will provide us an indication on the current performance requirements and will be our starting point for improving future user experience.
You can find the questionnaire to fill in at the following link:
https://ec.europa.eu/eusurvey/runner/Eusurvey_PLMPortal_UX_eAFcompletion
Please note that this survey should not take more than 5 minutes to complete, and the responses will remain anonymous.
We kindly ask you to respond to the survey by Thursday 29 February 2024.
Please send any question to plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
20-12-2023
Update on web-based Human variations electronic Application Forms (eAFs) implementation
As anticipated in October 2023, the electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with an update on the progress of the web-based Human variations eAF implementation on the Product Lifecycle Management (PLM) Portal
During Q4 2023, we completed the load and evaluation of PMS data in PMS User Acceptance Testing (UAT) environment, after which we proceeded to testing of PMS data in the PLM Portal. While performing these activities, we observed the following:
- Bugs in PMS related to match-merge* of Centrally Authorised Products (CAPs);
- Technical issues with the eAF preventing testing;
- System performance improvements required for the PLM Portal.
Taking into consideration these findings, we have made the necessary adjustments to planning. Kindly find here a visual representation of the updated plan.
Please note that Alpha UAT for Product User Interface (UI) data quality is still ongoing and proved successful thus far, as no blocking bugs have been identified.
Key points of the updated plan:
Q1 2024:
- Deployment in production of new eAF features (e.g., clone application, add package, rename application) developed in Q4 2023.
- Consolidation of all PLM portal products' development (eAF, Product UI, ePI) under a single service provider.
Q2 2024:
- Release of all CAPs & NAPs in the PMS database. Simultaneously, release of updated** CAPs in eAF;
- Delivery of PMS Application Programming Interface (API) - with CAPs and Nationally Authorised Products (NAPs) available in view-only mode - and Product UI - with CAPs available in view-only mode and NAPs not yet viewable.
Please note that, during the preparation for the updated** CAPs load in eAF in Q2 2024, the match-merge* operation will result in:
- changes to product names;
- introduction of new medicinal products through splitting*;
- potential alterations to packages;
This will impact how products appear in application forms. Therefore, we will communicate in due course the 3-week period where it is advisable to use the interactive eAF (PDF) instead of the web-based eAF for submissions to prevent validation issues and potential delays. Please note the web-based eAF will remain accessible to applicants to familiarise themselves with it and for training purposes.
Q3 2024:
- Performance improvements and internal testing
Q4 2024:
- Release of NAPs in the eAF
The updated planning does not foresee in 2024:
- external testing of the eAF UAT
- consequently, no transition start towards mandatory use of the Human variations web-based eAF. However, we would recommend the use of the web-based eAF for CAPs submissions following the updated** CAPs release.
Please send any questions to eSubProgofficer@ema.europa.eu or post them via the PLM Portal Forum.
*The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in EU IG Chapter 7
**Including split & match-merge processes. Please refer to EU IG Chapter 7 for a detailed description of these steps.
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.
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
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.
10-08-2023
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 1.0.1.11 released to production on the 07 of August 2023 are now available on PLM Portal Forum
01-08-2023
Updated PLM Portal eAF Guide to Registration is now available
Please find an updated version of the PLM Portal eAF Guide to Registration here.
PLM Portal eAF (DADI) documentation:
PLM Portal eAF webinars:
Update on Human Variations web based eAF implementation on PLM Portal (6 November 2023)
Human Variations web-based eAF Form training session (2 February 2023)
Human Variations web-based eAF Form training session (15 December 2022)
Human Variations web-based eAF Form training session (8 November 2022)
Human Variations Form go-live Q&A session (27 October 2022)
eAF Q&A clinic recordings:
- Human Variation eAF Q&A Clinic - session 7 (22 January 2023)
- Human Variation eAF Q&A Clinic - session 6 (17 January 2023)
- Human Variation eAF Q&A Clinic - session 5 (19 December 2022)
- Human Variation eAF Q&A Clinic - session 4 (14 December 2022)
- Human Variation eAF Q&A Clinic - session 3 (access management) (29 November 2022)
- Human Variation eAF Q&A Clinic - session 2 (22 November 2022)
- Human Variation eAF Q&A Clinic - session 1 (15 November 2022)
DADI PDF electronic application forms eAF training webinar (2 September 2022)
DADI PDF electronic application forms (eAF) training webinar (26 July 2022)
DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live - (12 July 2022)
Quarterly system demo (including DADI) - (28 June 2022)
DADI-PMS Webinar “Variations form for human medicinal products - What will happen at go-live” (16 May 2022)
Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms (18 January 2022)
Digital application dataset integration (DADI) - common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF) (25 January 2022)
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.
|
