CMDh and other EU updates – September 2025

Last updated: 29 September 2025

To view updates, click on the ‘+’ sign below:

EMA walk in clinic – Clinical Trials Information System (CTIS)

This video is a summary of the third CTIS (Clinical Trials Information System) Walk-in Clinic of 2025 held by the EMA on 24 September 2025 and includes a Q&A session with experts from the EMA and the Netherlands.

The discussion focused on technical and procedural questions related to the Clinical Trials Regulation (CTR) and its implementation in CTIS.

Below is a summary of the key questions and answers. Please verify the information relevant to you by viewing the video.

I. Application and Submission Procedures

• Access to RFI Parts [02:15]: For single-country trials, a single Request For Information (RFI) cannot technically unlock the entire application. To access both Part 1 and Part 2 of the dossier for a response, an RFI must be sent on each part.
• Submitting ASRs (Annual Safety Reports) in Parallel [14:17]: It is possible to submit ASRs while other assessments (like a substantial modification or member state concern addition) are ongoing. However, it is advisable to wait until a substantial modification to change the sponsor is finalized to avoid technical issues.
• Two Sponsors with Same Product [26:34]: If two commercial sponsors are conducting separate trials with the same investigational medicinal product (IMP), both are required to submit an ASR. They may collaborate to prepare and submit a joint ASR to CTIS for both trials.
• Non-Substantial Modification (NSM) Nearing End of Trial [29:08]: If there is no planned Substantial Modification (SM) before the end of the trial, remaining non-SM items (Article 81.9) do not need to be submitted in CTIS.

II. Trial Milestones and Reporting

• 30-Month Publication Calculation [03:52]: The deadline for the publication of a summary of results for a Category 1 trial is calculated as 30 months to the day from the end of the trial.
• End of Recruitment vs. End of Trial (LPLV) [04:53]: CTIS does not allow the end of trial date to occur before the end of recruitment. Sponsors must ensure the end of trial date occurs after the Last Patient Last Visit (LPLV) date in all countries, or they must provide supporting documentation to justify the selected dates [21:49].
• No Enrollment Results [19:00]: The obligation to submit a summary of results and a lay summary applies to all clinical trials, even if no participants were enrolled. Sponsors must still submit the summaries, indicating that no participants were recruited.

III. Protocol and Documentation

• Reassessment of Approved Documents [11:17]: The principle is that something previously assessed and authorized should not be reassessed during a later substantial modification; only the changes submitted should be assessed.
• DMC/DSMB Charter Reference [12:24]: A request to provide a statement in the protocol linking the Data Monitoring Committee’s (DMC) function to the 2005 EMA core guideline is not in line with the EUCTR.
• Deleting Incorrect Documents [17:18]: It is possible to delete an incorrectly uploaded document when responding to an RFI. If the document is for publication and has an associated “not for publication” document, the latter must be deleted first.

IV. CTIS Functionality and System Updates

• Site-Level Patient Numbers [18:14]: CTIS currently only supports entering the planned number of participants per member state, as required by Annex 1 of the CTR. Functionality to capture site-level enrollment is not foreseen.
• CTIS Updates and Drafts [25:50]: New releases of CTIS (e.g., v51.0, v52.0) do not affect applications already in draft.
• Planned Push Emails/Alerts [10:18]: Functionality to receive push emails for notices and alerts is under development and will be sent to the email address registered with CTIS. The exact implementation date will be announced via the Clinical Trials Highlight newsletter.

V. Special Topics and Future Guidance

• Complex Platform Trials [06:06]: Guidance on managing multiple EUCT numbers and master protocols for complex platform studies is being prepared by the Clinical Trials Coordination Group (CTCG) and will be published in an updated FAQ document.
• Fees [13:14]: Fee structures are not harmonized and differ per member state. For delays or lack of clarity on fees, sponsors are advised to contact the specific member state.
• Safety Information [30:26]: To quickly inform investigators of new safety information, sponsors should not wait for CTIS submission and authorization. A Dear Investigator Letter can be used for prompt notification.

Source: EMA via YouTube

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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 versions 1.2.0.12 and 1.2.0.13 released to production on 1 and 15 September 2025 are now available on PLM Portal and on the PLM Portal eAF web page

Important notes:

• The PLM Portal forms exported after the 2.2.5 FHIR bundle deployment (25 September 18:00) will contain the name of the section from the “Present/Proposed Changes”.
• The order of the sections in the PDF will be the same as the one in the PLM Portal.

Source: eSubmission

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Report from the CMDh meeting held on 16-18 September 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. Template for request for RMS in DCP
The CMDh agreed an update of the template for request for RMS in DCP.

• The document has been updated to add a footnote clarifying that, for bioequivalence studies, the applicant should verify that the site is included in the OMS database or request its inclusion at the earliest opportunity before submitting the application.
• The updated document has now been be published on the CMDh website under “Templates > Application for MA”. Here, you can view the track changed and clean (September 2025) versions of the document.

2. RMS validation checklist for human medicinal products in DCP
The CMDh agreed an update of its RMS validation checklist in DCP.

• The document has been updated to reflect Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use and the implementation of CEP 2.0. Additional boxes have been included for Module 2.2 and Module 2 (working documents).
• The document has also been revised in accordance with current Member States’ practices.
• The updated checklist document has now been published on the CMDh website under “Procedural Guidance > Application for MA”. Here, you can view the track changed (September 2022) and clean (September 2025) versions of the document.

3. Criteria for selection of products for SmPC Harmonisation
The CMDh has agreed to update the document on criteria for selection of products for SmPC
harmonisation.

• The document has been updated to clarify that an Article 30 referral can only be triggered for a particular medicinal product and that, generally, the marketing authorisations would belong to the same MAH.
• There were no changes to the criteria listed in the document.
• The updated document has now been published on the CMDh website under “Product Information > Referral Art. 30 and 31 (non-pharmacovigilance) > Harmonisation of SmPC – Article 30 Referrals”.
• Here, you can view the track changed (May 2017) and clean (September 2025) versions of the document

4. Timetables for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2026

• The CMDh has adopted an updated guidance document for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2026, in accordance with Article 29(1) of Directive 2001/83/EC, as amended, and Article 13 of Regulation (EC) No 1234/2008.
• The updated guidance document has now been published on the CMDh website under “CMDh-Referrals”.
• You can view the document Overview of timetables 2026 CMDh 60-day procedures for MRP/DCP applications here.

5. New applications in Mutual Recognition procedure and the Decentralised procedure started in July and August 2025

Here, you can view the stats in bar chart format.

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PLM Portal eAF – Strongly recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs

Following the launch of optional use in February 2025 and the start of the recommended use in May 2025, EMA now strongly recommends the use of the PLM Portal web-based eAF for all non-CAPs* human variations, wherever 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.
• Please report any production issues through the EMA ServiceDesk – Incident.
• Any change request or other generic questions, recommendations, improvement suggestions please raise them through EMA ServiceDesk – Request

PLM Portal web-based eAF use levels:
Optional Use: Both the interactive PDF and the web-based eAF are available. Applicants may choose either format, and no preference is expressed.
Recommended Use: The use of the web-based eAF is encouraged. However, applicants may continue to use the interactive PDF if they are not yet ready to adapt their internal processes.
Strongly Recommended Use: The web-based eAF should be used in most cases. The interactive PDF should only be used if specific constraints prevent the use of the web-based eAF (e.g., technical issues or missing features).
Mandatory Use: The use of the web-based eAF is required. Submissions using the interactive PDF will not be accepted. Mandatory use will only be introduced after a formally announced transition period.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

Source: eSubmission

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Q&A clinic on Product Management Service PMS Product UI and API

This video is a Q&A clinic on the Product Management Service (PMS) Product UI and API, hosted by the European Medicines Agency (EMA) [00:19]. The session, recorded on September 18, 2025, addresses various questions related to PMS, XEVMPD, and associated data management.

Here’s a summary of the key topics and responses:

• Housekeeping and Upcoming Events [00:30]:
  • The session is recorded and will be available on the EMA YouTube channel and event webpage.
  • Slido is used for Q&A, and interaction is voluntary.
  • Upcoming events include monthly PMS Q&As, webinars on PMS Product UI (October 6) and PMS API (October 16), and quarterly status updates for SPOR and XEVMPD (October 8).
• Authorized Dose Forms Issues [03:20]:
  • Most issues with authorized dose forms not appearing in the RMS list or Product UI have been resolved, with remaining fixes expected by the end of the week.
  • Users are encouraged to close related service now tickets if their products are now visible.
• UAT System API Test Phases for Externals [05:09]:
  • EMA is discussing the process for opening the UAT environment for the right PMS API to allow companies to test connections. More information will be provided in the October 16 webinar.
• MBO Start Date and Manufacturing Authorization Reference Number [06:07]:
  • PMS enrichment of MBO start date and manufacturing authorization reference number for 22 MBO RMS terms (recently published in EU IDMP IG Chapter 2) is now optional, not mandatory.
• Deadline for Split of Pack Sizes (Non-ULCM in XEVMPD) [06:50]:
  • The deadline for submitting all packages for non-Union List of Critical Medicines (ULCM) products has been extended to the end of 2027.
  • The enrichment of pack sizes for all non-CAPs in XEVMPD and submission of structured pack sizes in PI and API is extended until June 2027 [07:37].
  • The submission of manufacturer data for non-CAPs for the whole portfolio remains unchanged until the end of 2026 [07:53].
  • Users are advised to monitor the PLM portal’s “PMS news” section for updates on deadlines [08:02].
• Unretrieved Medicinal Products in PMS/PI [08:36]:
  • Resolution timelines depend on the specific issue (e.g., authorized form, holder). Specific tickets need individual investigation.
• Package Duplication (Belgium, Luxembourg, Finland) [09:44]:
  • Guidance will be updated to clarify how to handle package duplication for different languages. For now, the same information should be included in the package description to allow for merging [10:44].
• CRO MBO that No Longer Exists [11:21]:
  • Only active and approved manufacturers and manufacturing business operations should be included for initial enrichment. If a CRO no longer exists, it doesn’t need to be entered for initial enrichment unless it’s an approved manufacturer. Discontinued activities should be updated in PMS with an end date [11:44].
• Submission of Manufacturers (Finished Product vs. API/Excipient) [12:58]:
  • The submission of manufacturers is for all manufacturing business operations stated in Chapter 3, including active substance manufacturers, finished product manufacturers, CROs, and batch releasers [13:10]. Technical limitations currently prevent direct linking to active ingredients in PMS/API [13:56].
• Data Correct on XEVMPD but Not Migrated to PMS [14:53]:
  • PMS only allows editing of manufacturer and structured pack size data. For other discrepancies (e.g., ATC code), XEVMPD records should be maintained, and tickets should be opened if data is correct in XEVMPD but not in PMS.
• ESMP Monitoring and Deadlines [16:08]:
  • ESMP is already monitoring centrally authorized products (data from SAM) and non-CAPs. No further delays were mentioned for monitoring, but questions should be directed to the ESMP team.
• Data Carrier Identifiers for CAPs [17:15]:
  • Data carrier identifiers are currently not required for CAPs due to technical limitations and will only be available for non-CAPs to support the PC and PMS/API connection.
• Name and Name Part in PMS (Luxembourg and Finland) [18:28]:
  • A known bug exists regarding language identification for names, which is not a top priority for resolution currently.
• Pack Size Split and Duplicate Products in PMS [19:17]:
  • If pack size splits in XEVMPD result in new pack sizes receiving different active substances and creating duplicate products in PMS, a ticket should be opened for the XEVMPD team if the change is due to their validation, or for PMS if it’s a mapping issue [19:33].
• Deadlines for Manufacturer Submission (ULCM and Non-ULCM) [20:46]:
  • For non-CAPs impacted by the ULCM list, structured data and pack size submission is extended to June 2026.
  • For other manufacturers (not impacted by ULCM), the deadline remains December 2026.
  • Package submission (pack size in XEVMPD and PMS enrichment) is extended to June 2027 [21:48].
• Package Authorization Number in Description [22:21]:
  • While a free text field, it’s recommended to include the national ID at the beginning of the package description for easier identification and data extraction.
• Distributor as MBO [24:03]:
  • “Distributor” is not an RMS term requested by the inspections team for the manufacturing business operation list. Users are advised to contact the RMS or inspections team via a service now ticket for clarification [25:33].
• Legacy Products [27:01]:
  • For legacy products, the ability to provide lower granularity for MBOs is preferred, but higher-level terms are accepted if only that information is available from older dossiers.
• Automating PMS ID to XEVMPD Data Mapping [28:33]:
  • Through the API, users can download information relating PMS IDs, EV codes, and package IDs. The Product UI’s dynamic reports also provide this mapping [28:56].
• Pack Item Quantity Unit from RMS List [30:04]:
  • PMS is not yet requiring this information to be submitted. EMA is prioritizing other list reviews and will address this in future discussions with RMS.
• Blank Package Description in PMS/PI [32:01]:
  • This is a known bug where previous XEVMPR entries without package descriptions were used during migration. It’s a priority for Q4 2025.
• List of National Codes for Pack Size Description [32:58]:
  • This information is available in the PMS Q&A document on the PLM portal, outlining specific national codes for different countries.
• Previous EV Codes Sync with PMS/PI [34:28]:
  • During transfers, the new EV code replaces the previous one. Chapter 9 of the guidance explains this process.
• Checking Product Data (PMS vs. XEVMPD) [35:35]:
  • A previous webinar titled “PMS to support small and medium enterprises” offered tips on exporting and comparing data using Excel.
• CRO MBO Further Qualification [36:36]:
  • CROs involved in bioequivalence studies need to be submitted, regardless of when the activity occurred. For other manufacturers (batch releaser, etc.), currently approved ones are submitted, and data should be maintained with end dates for discontinued activities.
• Known Issues List [38:36]:
  • The latest list of known issues is available in the Q&A document on the PLM portal.
• Role for Adding Manufacturer/MBO in PMS [39:20]:
  • The “industry user” role (qualified industry user) is needed. The user guidance on the PLM portal provides step-by-step instructions on how to edit and where to find the edit button.
• Caps Timeline Extension [41:16]:
  • CAPs are out of scope for the enrichment timelines as necessary information is already available from SAM. Users should review existing manufacturer data and ensure all packages are submitted in XEVMPD upon CAP approval.
• Duplicate Medicinal Products in POI [42:09]:
  • A bug exists for duplicated products, a priority for Q4 2025. Tickets with EV codes should be opened for investigation.
• Withdrawn Products Enrichment [43:09]:
  • Withdrawn products do not need to be enriched for data like MBO or package description.
• Regional Authorities in PMS [43:24]:
  • The “authority responsible for granting” section should display regional authorities if they are recorded in MS. If not, an MS service ticket needs to be created.
• Adding Pack Sizes (PMS vs. XEVMPD) [45:04]:
  • New package presentations (pack sizes) with different EV codes should be submitted to XEVMPD as new records. The structured pack size data (e.g., “10 tablets”) is then edited in PMS to specify the details of the package submitted in XEVMPD [46:14].
• Splitting Pack Sizes for Non-Critical Medicines [46:59]:
  • Splitting packages in XEVMPD is necessary before adding structured data in PMS if multiple pack sizes are currently represented by a single package in PMS.
• Chapter 3 Publication [47:54]:
  • The updated Chapter 3 will be published once dependencies with the PDF EAF team are resolved, hopefully in a couple of weeks.
• Legal Basis Discrepancy (PMS/PI vs. XEVMPD) [48:47]:
  • EMA will take note of the reported discrepancy in the legal basis field.
• Application Tools for Data Comparison [49:17]:
  • EMA does not have tools to compare data between PMS and XEVMPD and has no plans to develop one as XEVMPD is being decommissioned. A webinar was held to provide tips for manual comparison using tools like Excel.
• Organization Data Discrepancy (PMS vs. MS) [50:11]:
  • Discrepancies (e.g., old company names, wrong log IDs after merges) are due to how Iris manages data from MS, affecting PMS and other systems. EMA is manually addressing tickets while internal discussions on a permanent fix continue [51:21].
• Full Presentation Name Discrepancy (PMS vs. XEVMPD) [52:49]:
  • This could be due to a lack of an EV code linked to a CAP in the Product UI, meaning information is only from SyAMed (which doesn’t capture pre-filled syringe details). Merging issues could also be due to inconsistent log IDs or EU numbers. Tickets should be opened if the issue persists after initial checks [53:50].
• Different MA Numbers at Pack Size Level in PMS [54:13]:
  • If products with different MA numbers at the pack size level appear as separate medicinal products, it’s advised to check Chapter 7 of the guidance for country-specific grouping rules and verify product name, active substance, strength, and MA holder in XEVMPD before opening a ticket [54:31].

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EMA Training session on Human variations web based electronic Application Form eAF for CAPs

This video from the EMA is a training session on the Human Variations web-based electronic Application Form (eAF) for Centrally Authorised Products (CAPs) [00:19]. The session, recorded on September 15, 2025, covers a quick recap and introduction, followed by a live demo and a Q&A segment [00:47].

Key topics and discussions from the training include:

• Agenda and Engagement: The session includes a live demo, a poll for attendees to indicate sections for a specific deep dive, and a Q&A session [01:06]. Attendees can use Slido to ask and upvote questions [02:01].
• Purpose of PLM Portal eAF: The new web-based form aims to replace outdated interactive PDF forms, offering a modern, web-based input form for applicants and providing regulators with a human-readable PDF output and machine-readable XML for easier digital processing [05:34]. It also moves towards ISO IDMP FHIR compliance structured data, simplifying procedure management [06:26].
• Important Dates: Strong recommendation for using the web-based eAF for CAPs has been in effect since May 2024 [07:24]. By the end of Q3 2025 (September), it is expected to be strongly recommended for all European human variation applications [08:06]. A significant update to EAF FHIR to version 2.25 is scheduled for September 25, 2025, which will bring improvements to the PDF and FHIR itself [08:32].
• Summer Quarter (Q3) Objectives and Improvements:
  • Form Versioning: The portal now supports two different form versions simultaneously to accommodate new variation regulations and classification guidelines coming into force on January 15, 2026 [09:15]. This allows users to continue working on procedures submitted before the new guidelines or start new applications using the updated guidelines [09:56].
  • MS Entity Linking: The “present and proposed” section now retrieves MS data directly, addressing a known issue where an Iris data layer was not always up to date [10:44].
  • Enhanced Editing: Improvements to the “present and proposed” section allow users to enlarge either the present or proposed sections for easier data entry [11:45].
  • Product Selection: Minor improvements have been made, with further enhancements expected by the end of September [12:00].
• Strongly Recommended Use: The web-based eAF should be used in most cases, with the interactive PDF only as a fallback for specific technical issues, missing features, or corrupted data [12:25]. Increased usage of the PLM portal form is encouraged to justify prioritization of future features like structured data and initial marketing authorization application forms [13:39].
• Usage Statistics: As of the training date, over 6,000 forms have been created in the PLM portal for centralized procedures, with over 3,200 submitted to the EMA, representing approximately 50-70% of all variation applications for centralized procedures [14:39]. The aim is to reach 90% by the end of 2025 [01:15:13].
• Known Issues:
  • Corrupted/Duplicate Products: There are still some corrupted and duplicate products affecting both CAPs and non-CAPs, which the EAF team is working with PMS and Iris data layer colleagues to resolve [01:17:07].
  • Organizational Data Issues: Issues with organizational data, particularly with merges of organizations, are being addressed with workarounds like direct retrieval from MS in some sections [01:17:40].
• Support and Feedback: Users are advised to use the EMA service desk for questions and incident reports, selecting the correct system (MS for organizational data, PMS for product issues) to avoid delays [01:18:29]. Consolidated feedback or bigger improvement suggestions can be sent via email [01:18:46].
• Live Demo Highlights (Based on Poll):
  • Product Selection: The demo showed how to search for and select medicinal products, filter them, and remove incorrect selections [27:43]. A limit of 50 products at a time is for performance, but users can repeat the selection process [01:19:32].
  • Present and Proposed Section: This section allows for adding text, tables, and images, with options to view just the “present,” “proposed,” or both simultaneously, offering more workspace [42:42]. Section titles can be added and reordered [47:03].
  • Add Package: The demo illustrated how to add a new package (e.g., a new pack size) to an existing medicinal product [53:28].
• Additional Information Section: This section is determined by choices made in procedural information (e.g., new indication, pediatric requirements) and includes details on orphan procedures, market exclusivity, and pediatric details [56:03].
• Finalization: The form requires all sections to be ticked green before finalization [01:00:36]. An integrity stamp is added upon finalization, which serves as a system signature. Additional digital signatures can be added if company policy requires it [01:03:27].
• Q&A: Topics covered included MA number display, mandatory use date (no fixed date yet due to data issues), updating medical device details (guidance and video to be provided), PMS data quality concerns, copying tables and graphs, and the acceptance of web eAF by NCAs [01:05:14].

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EMA Public System Demo Q3 2025

This video is a recording of the Public System Demo for Q3 2025 by the European Medicines Agency (EMA) on 17 September 2025.

• The video is hosted by Jean-Michel, who explains that the system demo is a chance for agile teams to show what they’ve developed over the past three months [02:24].
• The first demo, presented by Anna, is on the modernization of the Clinical Trials Information System (CTIS) [05:47]. New features include:
  • Search capabilities A new screen will allow users to perform searches related to product and substance groups and view related clinical trials [08:33].
  • Substance group lookup Another new screen will show information from both CTIS and XEVMPD to aid in selecting the correct substance group [11:11].
  • Safety alerts The new system will inform authority users of new substance groups added to the safety module through notices and alerts [17:00].
  • Improved ASR creation The new safety module will allow users to create and edit draft Annual Safety Reports (ASR) [19:46].
  • Trial map The CTIS public portal will feature a new map with yellow dots for recruiting sites and blue dots for non-recruiting sites [26:35].
• The video also discusses a compliance report in the EVAS system, which is measured for each submitted Individual Case Safety Report (ICSR) [03:18:24].
• Reports excluded from the compliance notification are error reports [03:19:35], nullification reports [03:19:55], and amendment reports [03:20:12].

Source: EMA

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eCTD v4.0 technical pilot phase 2 update

EMA is pleased to announce that the phase 2 of the eCTD v4.0 EU Technical pilot (CAPs) continues and is progressing well.

• It is receiving submissions and useful findings have been made.
• Participants should note that phase 2 is being extended the until the end of September 2025 to ensure that there is time to receive and analyse further packages following important fixes into the review tool.
• EMA would also like to highlight to users, the importance of using priority numbers and careful use of keywords to ensure that sections, such as 1.3 are not displayed multiple times.

Source: eSubmission

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eCTD 3.2.2 – EU M1 v3.1.1 and Validation Criteria v8.2 accepted from 1st October

As previously announced, the updated EU M1 specification v3.1.1 and the related Validation Criteria v8.2 are accepted from 1st October 2025 kicking off 2 months transitional period during which both the current and the new specification and validation criteria can be used.

• The mandatory use of the updated specification and validation criteria will commence on 1st December 2025.
• The changes are reflected in the Release Notes.
• From 1 October 2025 eCTDs compliant with EU M1 v3.1 or v3.1.1 and validation criteria v8.1 or v8.2 will be accepted.
• From 1 December 2025 only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 will be accepted.

Source: eSubmission

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EMA training session on Human variations web based electronic Application Form eAF non-centrally authorized products (non-CAPs)

This EMA webinar was held on 10 September 2025. It is a training session on the Human Variations web-based electronic Application Form (eAF) for non-centrally authorized products (non-CAPs) [00:29].

• The session covers the benefits of the new web-based form, which include a modern interface, automated data imports using SPOR elements, and improved efficiency [04:33].
• It also outlines the timeline for “strongly recommended” use of the eAF by September 29th, 2025 [08:21].
• A live demonstration is provided, walking through key sections of the form, such as version selection, product selection, and handling of proposed changes [01:21:57].
• The video concludes with a Q&A session that addresses topics like digital signatures on the form, the ability to export XML, and the mandatory use of organizations registered in MS for proposed changes [02:10:40].

Source: EMA

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New PMS functionalities to become available soon for non-Centrally Authorised Products (non-CAPs)

New PMS functionalities will soon be available for non-Centrally Authorised Products (non-CAPs), following the successful completion of two rounds of UAT:

• PMS Product User Interface (PUI) – Bulk write: available from 22 September 2025
• Application Programming Interface (API) – Write access: available from 25 September 2025

While Marketing Authorisation Holders (MAHs) can already edit their non-CAPs data via the PUI, these enhancements will make data management even more efficient:

• Bulk edit multiple products at once through the PUI
• Submit data directly from your own systems via the API

Source: LinkedIn (EMA)

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PRIME eligibility requests -2026 Deadlines for submission and timetable for assessment

You can view the table for PRIME eligibility requests -2026 Deadlines for submission and timetable for assessment here.

Source: EMA

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CMDh annotated QRD template for MRP/DCP

Here, you can view the track changed (April 2021) and clean (MArch 2024) versions of the document.

It would appear (based on the limited information provided) that this is a March 2024 correction applied in September 2025.

Source: HMA

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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

This guidance was updated on 8 September 2025. Here, you can view the track changed (July 2025) and clean (September 2025)versions of the document.

The changes to the document are in the following sections:

• 1.6.3. Article 10a – Well-established use application
• 2.4.1.1. Requesting the appointment of CHMP/PRAC/CAT Rapporteurs/Co-Rapporteurs and their assessment teams
• 2.7. How should I notify a change in the contact person and/or intended
• submission date of my application?

Source: EMA

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Q&A clinic on PMS product user interface and API, 28 August 2025

This EMA webinar was held on 28 August 2025. A summary of some of the items discussed is is provided below.

This webinar is a Q&A clinic on the Product Management System (PMS) user interface and API. It addresses user questions on various topics, including:

• Chapter 3 and PUI Updates: Chapter 3 is expected to be released in September, along with an update to the Product User Interface (PUI) [00:26]. The PUI update was delayed but is now scheduled for September, before the go-live date [00:57].
• Handling Manufacturer Data: If a manufacturer resumes an activity, they should update the status to “active” and keep the original start date [02:08]. The system currently does not allow for connecting a manufacturer to the substance level [03:16].
• Legacy Products: The definition of “legacy products” will be clarified in Chapter 3 [04:51].
• Training and Test Environments: The EMA plans to provide a training environment for PMS and aims to deliver a test environment for API testing before the go-live date [06:04]. A test environment for the PMS API will be opened for two weeks each month starting in October [07:10].
• Validation Rules and Data Integrity: The EMA is working to ensure that validation rules in the API allow for data submission without being blocked by business rules that are not yet enabled [09:44]. Information on fixes and known issues can be found on the PLM portal under “Q PMS Q&A” [11:17].
• Upcoming Functionality: The bulk update functionality [26:31] and Edit API access for non-caps products [22:44] will be available at the end of September.

Source: YouTube

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eAF training demo July 2025

This EMA webinar was held on 1 July 2025 and published a couple of days ago on YouTube. A summary is provided below

The webinar is a training demonstration on how to use the electronic Application Form (EAF) system. It covers the following key points:

• Getting Started: The video explains that you must be registered with a pharmaceutical company to access the EAF system. You can start a new application or access previously created forms from the EAF list [00:41].
• Creating a New Form: The process of creating a new form involves naming it and selecting a reference Marketing Authorization Holder (MAH) [02:26]. A critical point is that the selected MAH cannot be changed later [04:29].
• Adding Products: The video demonstrates how to select products for the form, noting that there’s a limit of 50 products at a time for performance reasons [08:01]. It also shows how to search and filter products and how to associate MRP numbers [10:09].
• Form Sections and Features: The video walks through various sections, including Procedural Information, which automatically calculates details [18:49], and the Changes section for detailing proposed changes [22:27]. It also highlights new features like the ability to clone a scope [17:44] and a planned “sticky save button” [11:17].
• PDF Export: The video concludes by showing how to export the completed form as a PDF, which is similar to the familiar interactive PDF [36:11]. The automatic calculations and pre-filled sections save the user from manual data entry [37:26].

Source: YouTube