Last updated: 2 July 2025
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PLM Portal FHIR XML version upgrade
The PLM portal FHIR XML version was updated to 2.2.3. The new version introduces the following changes:
• There’s a new extension in (sub)Task.code.coding[system=https://spor.ema.europa.eu/v1/lists/100000152091].extension[system=http://ema.europa.eu/fhir/termName].valueString containing the full name of the scope. For example: “B.II.e.7.a Deletion of a supplier”, instead of “B.II.e.7.a”
• The DataCarrierIdentifier identifier was moved from PackagedProductDefinition.package.identifier to PackagedProductDefinition.identifier
The Release notes can be found here.
- The next upgrade of the PLM Portal FHIR XML (2.2.4) is currently planned for the end of July 2025, and the date will be confirmed in due time.
- The version 2.2.4 will introduce a change on the HTTP protocol of the links referenced in the FHIR message.
- The recommended FHIR protocol is HTTP, therefore all the links currently using HTTPS will be changed to HTTP.
Source: eSubmission
eCTD v4.0 Technical Pilot – Step 2 started
The electronic Common Technical Document (eCTD) v4.0 has launched Step 2 of the eCTD v4.0 Technical Pilot, for Centrally Authorised Products (CAP).
- Please note that participation is very limited and participants will be selected based on the readiness and compliance with the scenarios and focus described in the table below.
- Interested MAHs are invited to provide details of their proposed products, scenarios and very importantly the name of the eCTD v4.0 tool, by 15 July 2025 via email to eCTD4consultation@ema.europa.eu.
- Upon confirmation from EMA details will be sent on how test packages can be submitted
| Scenario No | Scenario description | Focus on | |
|---|---|---|---|
| Scenario 1 | Initial MAA (sequence 1); EMA will prioritise for processing those MAHs who can resubmit sequence 1 for an existing/already authorised CAP (previously created in eCTD 3.2.2, sequence 0000, even if currently is not a valid product anymore), and now re-created/converted (fully or partially) in eCTD v4.0. | i) controlled vocabularies ii) different file formats iii) multiple pack sizes, manufacturers | |
| Scenario 2 | Initial MAA (sequence 1) for a Duplicate product sent in scenario 1 (the Duplicate product can be a mock product; this will facilitate early testing of Grouped submissions functionality, which is planned for Step 3) | i) Document reuse ii) different file formats | |
| Scenario 3 | Validation responses (starting with sequence 2), responses | i) Document lifecycle management (replace context of use (one to one, one to many and many to one), delete) ii) Updating keywords, priority numbers, and document titles iii) Regulatory activity (Submission and related sequences for 1 regulatory activity) | |
| Scenario 4 | Post authorisation activities (different procedure types and multiple sequences related to the products sent in sequence 1) | i) Document lifecycle management (replace context of use (one to one, one to many and many to one), delete) ii) Updating keywords, priority numbers, and document titles iii) Parallel regulatory activities |
In Step 2 (the planned initial duration of this step is 2 months: 15 July 2025– 15 September 2025, subject to extension if necessary) of the eCTD v4.0 of the technical pilot there will be no focus on Grouped submissions functionality, forward compatibility. These will be tested in Step 3, planned for late Q3 2025.
Please note: All communication will be done via email and depending on the number of test packages received and EMA eCTD v4.0 team availability, there might be a delay in the response time.
Source: eSubmissions
CAT quarterly highlights and approved ATMPs
This report provides information on Advanced Therapy Medicinal Products (ATMPs) approvals and extension of indications of authorised ATMPs, as well as statistical data on product-related activities. The period covered by this report is: February – May 2025.
You can see a visualisation of the table on pages 4 and 5 of the report here and the stats concerning the table, at this link.
Source: EMA
Updated PLM Portal eAF Release notes now available
An updated version of the Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.7 released to production on 23 June 2025 are now available on PLM Portal and on the PLM Portal eAF web page
Updated PLM Portal eAF guide to navigation now available
An updated draft version of the PLM Portal eAF guide to navigation is now available. The guide to navigation contains part of the new UI/UX design, and more updates will be added in future versions of the guide.
Source: eSubmission
Report from the CMDh meeting held on 17-19 June 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.
The report from the above meeting include (but is not restricted to) the following items:
1. Guidance on the application of the revised variations framework
Following the revision of the Variation Regulation applicable since 1 January 2025, the European Commission has now published a draft version of the new EC guidelines on the details of the various categories of variations and operation of the procedures and expects them to apply from 15 January 2026 (as provided in the published draft version of variations guidelines).
Updated guidance is expected to be published by the end of the month regarding the application of the new variation framework and the impact on the submission of variations. Stakeholders are invited to monitor the EMA and CMDh webpages and to take the necessary measures to prepare their systems, processes, procedures and documentation for compliance with the revised variation framework.
2. MWP advice to CMDh on bridging requirements for well established use applications
The CMDh endorsed the advice provided by the CHMP Methodology Working Party (MWP) on bridging requirements for well-established use applications (WEU; Article 10a of Directive 2001/83/EC).
- The MWP advice includes a Q&A document providing further clarification on the requirements for bridging data in the context of WEU applications, i.e. when an active ingredient of a medicinal product has been in well-established use for at least 10 years within the Union with a recognized efficacy and an acceptable level of safety.
- The Q&A document will be published on the EMA website and linked on the CMDh website under “Procedural Guidance > Application for MA”.
A link will be provided here once it becomes available.
3. CMDh guidance documents on national requirements for submissions of variations, renewals and new MAAs in MRP/DCP
The CMDh agreed an update of several CMDh guidance documents on national requirements for submissions of variations, renewals and new MAAs in MRP/DCP:
- Requirements on submissions for variations and renewals within MRP and national procedures. Here you can view the track changed (July 2024) and clean (June 2025) versions of the document.
- Requirements on submissions for new marketing authorisation applications within MRP, DCP and national procedures. Here you can view the track changed (July 2024) and clean (June 2025) versions of the document.
- Data requested for variations and/or renewal applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, presentation and format of the dossier common technical document (CTD) and/or in the EEA approved guidelines/ recommendation papers. Here you can view the track changed (November 2023)) and clean (June 2025) versions of the document.
- Data requested for new applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, presentation and format of the dossier common technical document (CTD) and/or in the EEA approved guidelines/ recommendation papers. Here you can view the track changed (August 2024) and clean (June 2025) versions of the document.
The guidance documents have been revised following the introduction of the PLM Portal eAF Integrity stamp feature. The existing national requirements have been reviewed and simplified by Member States, as far as possible.
The updated documents have now been published on the CMDh website under “Procedural Guidance> Variation” and “Procedural Guidance> Application for Marketing Authorisation”, respectively. You can view them with the links provided above.
4. CMDh SOP on the processing of PSUSA procedures for nationally authorised products
The CMDh agreed an update of the CMDh Standard Operating Procedure on the processing of PSUR single assessment procedures for nationally authorised products.
- The guidance document has been updated to reflect that having been the lead Member State during the previous EU informal PSUR worksharing project should no longer be a criterium for automatic appointment as PSUSA LMS.
- The updated SOP will be published on the CMDh website under “Pharmacovigilance > PSUR > PSUR Single Assessment”
Here yo can view the track changed and clean (June 2025) versions of the SOP
5. Meeting with representatives of Interested Parties
The CMDh convened a meeting with Interested Parties on 19 June 2025.
The topics on the agenda included, amongst others:
- the implementation of the Variation Regulation/Variations Guidelines,
- the project on publication of outcomes of safety variations, the revision of the CMDh MAWP
- digitalisation
- labelling, and
- the predictability of submissions, resources, workload.
All presentations have now published on the CMDh website under “About CMDh > Contact with Representative Organisations”. Links are provided below.
CMDh – Feedback from SOS WG
AESGP – Implementation of the Revised Variations Regulation
CMDh – FAQs on the Revised Variations Regulation
CMDh – Multi-Annual Workplan
Medicines for Europe – Priorities in Digitalisation
EFPIA – Labelling
Medicines for Europe – Predictability of Submissions / Data Requirements New Submissions
6 Stats concerning New applications in MRP and DCP started in May 2025
You can view the stats concerning New applications in MRP and DCP started in May 2025 on pages 5 and 6 of the report. Here is a visualisation of the stats of the top 10 countries.
User guide of the HMA-EMA Catalogues of real-world data sources and studies
Version 2.0 (June 2025) of the above guide is now available.
The User guide of the HMA-EMA Catalogues of real-world data sources (RWD) and studies has been developed for users submitting data to the Catalogues (i.e.: data holders and investigators submitting study data) to help them navigate the Catalogues in this context.
- The user guide provides descriptions of the data fields and definitions, as well as guidance on how to submit and maintain a record in the Catalogues.
- A Good Practice Guide for the use of the HMA-EMA Catalogues of RWD sources and studies has also been published to provide regulators, researchers (including academia and pharmaceutical industry) and other interested stakeholders with recommendations on the use of the catalogues from the perspective of the data user.
- Specifically, the guide focuses on describing the steps and best practices on identifying a suitable data source, when planning a study.
Updated PLM Portal eAF Release notes now available
An updated version of the Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.6 released to production on 10 June 2025 are now available on PLM Portal and on the PLM Portal eAF web page
eCTD 3.2.2 – new package available
New versions of the following have now been published:
- EU eCTD M1 Specification, version 3.1.1 has been published on the eSubmission website . The version 3.1.1 sees the introduction of a small number of changes in the specification, related to the tracking table for EDQM and new examples of product numbers and procedure numbers for work-sharing and super-grouping. The changes are reflected in the Release Notes .
- Validation criteria v8.2 has been published on the eSubmission website. The version is related to the EU Module 1 Specification version 3.1.1 and should be used in case of submitting a new sequence according to EU M1 specification v3.1.1. The new validation criteria will be used for the technical validation for all v3.1.1 electronic submissions received as of 1 December 2025 to the NCAs and EMA. The changes are reflected in the Release Notes.
- Harmonised guidance eCTD 6.0.1 has been published together with the new version of the specification and the validation criteria
Note: The Util files remain the same
- During the initial period of 4 months from 2 June 2025 to 30 September 2025, applicants can only submit eCTD format submissions compliant with EU M1 v3.1 and validation criteria version 8.1.
- From 1 October 2025 eCTDs compliant with EU M1 v3.1 or v3.1.1 and validation criteria v8.1 or v8.2 are accepted.
- From 1 December 2025 only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 are accepted.
Source: eSubmission