Last updated: 8 October 2025
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Q&A Clinic on web based electronic Application Form eAF functionalities
This is a video of a Q&A Clinic webinar hosted by the EMA on 30 September 2025 on the functionalities of the web-based electronic Application Form (eAF), including demonstrations of new and updated features.
Below is a summary of the key topics:
Important Updates and Recommendations
- Strongly Recommended Use [02:32]: The web-based eAF is now strongly recommended for all variations, including non-centrally authorized products (MRP, DCP, and purely national procedures). The interactive PDF form should only be used if specific technical constraints or missing features prevent the use of the web-based eAF.
- Annual Notifications/Updates [12:15]: There is currently no dedicated tick box for annual updates. Users should include these details in the background and justification for grouping section and clearly identify the submission as a Type 1A annual update in the cover letter and eAF.
- Editing the eAF [28:07]: The exported PDF is a rendition and cannot be edited. All changes must be made in the PLM portal, followed by a new export.
- Reusing a Form [26:34]: To reuse a completed eAF, users are strongly advised to clone the form rather than reopening an already submitted form. This prevents discrepancies if the original form needs an update later.
Demonstrated Features (Deployed Last Night (i.e. 29 September 2025)
The session included a demonstration of an updated feature to enhance the user experience:
- Updated Product Selection Feature [03:58]:
- The form now opens directly into a product grid, eliminating the initial empty screen.
- The product list default view will soon increase from 10 rows to 50 or 100.
- You can easily delete a selected product by unticking the box next to it in the selected products list and clicking save [38:13].
- Proposed Changes Section Reordering [08:43]: Users can now reorder the sections they add to the “proposed changes” by moving them up or down. The selected order will be reflected in the final exported PDF.
Upcoming Features
- Versioning Support [15:26]: Support for different versions of the variation classification guideline is being introduced.
- Reference MAH Selection [16:05]: Users will soon be able to select the reference MAH name directly from MS (Master Data Management System) data to solve existing data limitations that block some users.
Q&A on Digital Signature
- MAH Signature [17:13]: If an MAH requires an Adobe signature (e.g., for certain EU authorities), the applicant should export the form before finalizing (to avoid the integrity stamp), have the MAH sign it, and then submit this signed version as an annex (in ECTD section 1.2.2) alongside the official, finalized form containing the EMA integrity stamp. For EMA procedures, the integrity stamp alone is considered sufficient [18:36].
Source: EMA via YouTube
EMA Management Board: highlights of October 2025 meeting
A small number of highlights from this meeting are listed below:
- Positive trend in reduction of company clock stop extensions in Q1-Q2 2025
- The Board welcomed the positive trend in reduction of company clock stop extensions in Q1-Q2 2025 – an average of 150 days compared to an average of 182 days in 2024 (an approximately 18% reduction).
- This was achieved via EMA’s initiative to reinforce best practices for requests for clock stop extensions from companies.
- The OPEN Framework
- The EMA collaborates with medicine regulators outside the EU in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities).
- This was originally endorsed by the Board in December 2020 to allow medicine regulators from outside the EU and the World Health Organization to take part in EMA’s scientific evaluation of COVID-19 vaccines and therapeutics.
- The Board has now agreed to expand the scope of EMA’s OPEN Framework to include all medicines that target
- unmet medical needs and
- advanced therapy medicines products (ATMPs).
- The Board also agreed to allow the use of the OPEN framework for post-authorisation changes, including extensions of indication.
- A Q&A document on this expanded scope will be published towards the end of the year.
Source: EMA
EMA advice on end-of-year submission dates for type I variations in 2025
- Type IA and type IAIN variations and super-groupings
- MA holders are advised to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025.
- This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2025 and 5 January 2026, within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
- Annual updates should be submitted according to the timelines stated in the revised Variation Regulation and published guidance on application of revised variations framework.
- Type IB variations or groupings of type IBs and type IAs
- MA Holders holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2025 for a start of procedure in 2025.
- For submissions received on or after 1 December 2025, the procedure may not start until January 2026.
Source: EMA
New PMS PUI & API functionalities are now live
PMS Product User Interface (PUI) – Bulk Write (launched 22 September 2025)
This functionality allows MAHs to submit non-CAPs in bulk high volume of structured data set of approved data to comply with ESMP timelines and start enriching PMS using PUI tool
PMS Application Programming Interface (API) – Write Access (launched 25 September 2025)
This functionality allows MAHs to efficiently submit large volumes of structured non-CAP product data updates via the PMS API, supporting ESMP, shortage reporting, and contributing to PMS data enrichment.
Source: LinkedIn