Last updated: 24 October 2025
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Report and minutes from the CMDh meeting held on 14-15 October 2025
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
Acronyms and abbreviations used in the report and minutes are available here.
The report from the above meeting includes (but is not restricted to) the following items:
1. Update of CMDh guidance documents to reflect new Variation Guidelines
The CMDh agreed updates of several guidance documents and templates related to variations to bring them in line with the new EC guidelines on the details of the various categories of variations and operation of the procedures.
- The new EC guidelines, as well as the correspondingly updated guidance documents by CMDh will apply from 15 January 2026.
- The updated documents and further guidance on the application of the revised variations framework will be published on the CMDh website under “Procedural Guidance > Variation > Revised Variations Framework”
Links will be provided here once available.
2. PLM Portal eAF – Strongly recommended use of web-based Human variations electronic Application Forms (eAFs)
Following the launch of optional use in February 2025 and the start of the recommended use in May 2025, it is now strongly recommended to use of the PLM Portal web-based eAF for all MRP/DCP and purely national variations, where possible.
- This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.
- Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now strongly recommended for use for all procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf forms.
- Consult the guidance and the release notes.
3. Update of guidance related to Brexit
The CMDh reviewed the existing guidance related to Brexit and agreed to combine the two existing guidance documents into a single post-Brexit Questions & Answers document.
- The subpage dedicated to Brexit will be removed from the website.
- Obsolete Q&As have been deleted and/or amended as appropriate.
- Marketing authorisation holders are reminded that any remaining batch control and batch release sites located in the UK(GB) should be removed from the marketing authorisation using the respective variation procedure according to the classification guideline.
- This should be done at the earliest opportunity for all procedures except for procedures with UK(NI) as CMS where the competent authority of UK(NI) has granted an exemption for its market.
- The derogation period for Cyprus, Ireland and Malta ended on 31 December 2024.
- The new Q&A document has now been published on the CMDh website under “Questions & Answers”. You can view it here.
4. Recommendations on submission dates for applicants of the DCP and MRP
- The CMDh has adopted updated guidance documents with the timetables for MRP/DCP applications to be submitted in 2026.
- The updated guidance documents have now been published on the CMDh website under “Procedural guidance > Application for MA > MRP/DCP”.
You can view them at the links below:
- Recommendations on submission dates in 2026 for Applications of the MRP
- Recommendations on submission dates in 2026 for Applications of the DCP
5. Update of the Overview Assessment Report template
The CMDh agreed on an updated version of the DCP D70 Overview assessment report template including instructions.
- The document has been updated to include further standardised wording to guide assessors in completing the assessment report.
- The updated template will be published on the CMDh website under “Templates > Assessment Reports > DCP (AR/Comments)”. You can view it here.
6. New applications in the MRP and DCP started in September 2025.
At this link you can view the stats (tabulated on pages 4 and 5 of the report) as bar charts.
CTCG Simplified template of annual safety report
The The Clinical Trials Coordination Group (CTCG) has developed a Simplified template of Annual Safety Report.
- Non-commercial sponsors conducting a single clinical trial on IMPs with a MAH in any of the EU/EEA member states and where the SmPC is used as RSI submitting this simplified ASR based on the ICH-E2F may be appropriate.
- This template gives detailed instructions on what information is expected and what may be omitted in this setting. The simplified ASR should always be written in English.
Source: HMA
Updated – IRIS guide for applicants – How to create, submit and manage IRIS applications, for industry and individual applicants
The latest version of this guide is 3.10 dated 15 October 2025. You can view it here.
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 1.2.0.15 released to production on 13 October 2025 is now available on PLM Portal and on the PLM Portal eAF web page.
Source: eSubmission
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