- 13/07/2023 Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 (updated)
- 12/07/2023 Other: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (updated)
- 12/07/2023 Other: Annex I - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.1 (updated)
- 12/07/2023 Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 2 , Online, 15:00 - 15:30 Amsterdam time (CET), from 22/06/2023 to 22/06/2023 (updated)
- 12/07/2023 Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 1 , Online, 15:00 - 15:30 Amsterdam time (CET), from 15/06/2023 to 15/06/2023 (updated)
- 10/07/2023 Other: European Medicines Agency Guidance for applicants seeking access to PRIME scheme (updated)
We inform you that the timeline of the variations web-based electronic Application Form (eAF) for Human medicinal products has been updated.
EMA is continuing development work with the aim to incrementally build the new web-based eAF, leveraging on Product Management Service (PMS) data. The key priority for the Agency is to ensure that the eAF is supported by a stable system with high-quality data before starting any transition. During recent testing, it became clear that the target date for the release of split CAPs and NAPs on the PLM Portal requires to be extended. This is due to the additional time needed to perform checks on data quality and the quality of the data transfer of NAPs data, investigate and address potential issues connected to product data transfer and (if needed) repeat the loading of the data.
Therefore, in order to respect our commitment to ensuring that all stakeholders are kept informed on key milestones with reasonable advance notice, please be informed of the new target dates for the release of split Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in web-based eAFs on the Product Lifecycle Management (PLM) Portal:
- release of split CAPs, making them available to use in the eAF, is now expected in October 2023 instead of July-August 2023
- target date for the release of NAPs is now expected between November 2023 and February 2024 instead of July-August 2023.
Consequently, the human variations web-based electronic Application Form (eAF) target timeline (last published in April 2023) has been reviewed. Please find here the updated version, which reflects the target dates for each milestone. Kindly note the eAF team expects to provide a further update to confirm the timeline in September 2023, based on latest testing outcomes.
Please be informed that key milestones following split CAPs and NAPs release in web-based eAF on the PLM Portal will be consequently rescheduled. In particular, the external User Acceptance Testing on the version of the web-based eAF intended to replace the PDF and trigger the transition will be rescheduled from November 2023 to a yet-to-be-defined date which will be announced at least two months in advance, as per prior commitment. The transition period will also be announced in due time.
Please note that EMA is following the previously communicated development steps for the products' release on the PLM Portal:
- Load product data into the test environment;
- Test data quality and quality of the transfer;
- Investigate issues, address them and repeat the first 2 steps;
- Once ready, transfer product data into the production environment.
In the meantime, applicants are encouraged to use the human variations web-based eAF already available in the PLM Portal for products already in the system and maintain high the level of data quality of their products in XEVMPD.
We are pleased to inform you that the next version of the Common Repository introducing the 'Basic Authentication' is going live on the 18th July 2023.
This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products.
For the completion of the deployment, Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Tuesday evening, 18th of July 2023 between 18:00 and 19:30 (CET).