Last updated: 27 August 2025
To view updates, click on the ‘+’ sign below.
eCTD v4.0- Controlled Vocabularies v2 (genericode format) now available
- The genericode format of the EU eCTD v4.0 controlled vocabularies (v2) (published on the 8th of August in excel format only) is now available.
- A new version (v3) will be published in the upcoming weeks, containing new terms and corrections of existing terms.
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) is ongoing, and progressing as planned.
- Participants should take note that “multiple pack sizes” (Scenario 1) is not meant to be reflected in the structure of the submissionUnit.xml, but it is simply related to the content (the documents) of the test applications.
Source: eSubmission
PLM Portal eAF – FHIR 2.2.5 – planned for 25 September 2025
The PLM Portal eAF FHIR is planned to be updated to version 2.2.5 on 25 September 2025, EOB. Please contact plm.valuestream@ema.europa.eu should you have any concerns about the planned release.
The upgrade will contain the following changes, reflected in the eAF FHIR Data Requirements:
- Introduction of 3 new extensions, to harmonise the eAF extensions with PMS extensions:
- Pediatric Use Indicator (MedicinalProduct – J370 in the AF Data requirements excel); FHIR Path: MedicinalProductDefinition.pediatricUseIndicator.coding.system (http://ema.europa.eu/fhir/paediatricUseIndicator)
- Additional Monitoring Indicator (MedicinalProduct – AB17 in the AF Data requirements excel); FHIR Path: MedicinalProductDefinition.additionalMonitoringIndicator.coding.system (http://ema.europa.eu/fhir/additionalMonitoringIndicator)
- GMO (MedicinalProduct – AB363 in the AF Data requirements excel) FHIR Path: MedicinalProductDefinition.characteristic.type.coding.system (http://ema.europa.eu/fhir/gmo)
- Introduction of 1 new extension to support versioning
- FHIR Path: Bundle.profile e.g. <profile value= http://ema.europa.eu/fhir/definition/eaf-portal-version/1.0.0.0 /> This element is to support the versioning. Only when 2 sub-versions will need to run in parallel (and it will be the case with the new variation classification), the users creating the forms will pick an extra value in the form. It will be, for example “Current” and “Future variation”. The web release version (e.g. 1.2.0.10) is already in the FHIR message; this extra element will capture the sub-version mentioned above
- Introduction of 2 new extensions and deletion of obsolete 2 extensions, used for the sections in present/proposed changes:
- Changes: (new) Section Label (Variation – AB225 in the AF Data requirements excel) FHIR Path: Provenance.extension[url=http://ema.europa.eu/fhir/extension/unstructuredCurrentProposedHtmlText].extension[url=label].valueString In the present/proposed web interface, there are labels for sub-sections; these labels will be, with the new FHIR version, printed on the PDF (there were many requests for this change, from the MAH)
- Changes: (new) Organisation reference (Variation – AB226 in the AF Data requirements excel) FHIR Path: Provenance.extension[url=http://ema.europa.eu/fhir/extension/unstructuredCurrentProposedHtmlText].extension[url=organisationChange].valueReference (reference to an organisation provenance (Provenance.extension[url=http://ema.europa.eu/fhir/extension/provenanceType].valueCoding.code==90000000998) This element is to link the Present/Proposed organisation with a specific section of the Present/Proposed; currently it is under the whole “Present/Proposed“ entry, and not linked to potential sections of that entry
- Changes: (removed) Obsolete present text field (kept since 4.6.0 for retro-compatibility) (Variation – AB72 in the AF Data requirements excel) FHIR Path: Provenance.extension[system=unstructuredCurrentValueHtml].valueString This extension is obsolete, as it was located at the root of the scope change; now the extension is at the section level
- Changes: (removed) Obsolete proposed text field (kept since 4.6.0 for retro-compatibility) (Variation – AB73 in the AF Data requirements excel) FHIR Path: Provenance.extension[system=unstructuredProposedValueHtml].valueString This extension is obsolete, as it was located at the root of the scope change; now the extension is at the section level
Source: eSubmission
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 1.2.0.11 released to production on 19 August 2025 are now available on PLM Portal and on the PLM Portal eAF web page.
Source: eSubmission
eSubmissions survey for EMA Gateway users
The EMA has initiated a brief, anonymous survey for the above.
The EMA uses its eSubmission Gateway and Web Client to manage electronic submissions for medicinal product applications.
- This includes submissions for marketing authorizations, variations, and other regulatory procedures.
- The web-based Gateway Web Client is especially convenient for small to medium-sized companies.
- Both channels automatically confirm technical validation and upload your submission to the EMA’s eCTD review system.
- Your feedback is sought on the eSubmission process.
- The EMA understands that as a user, you are familiar with the steps, including compiling a ZIP file, filling out an XML delivery file and submitting it to the Gateway.
- Please take a moment to share your feedback so that the EMA improve the system for everyone.
- Your feedback is confidential and will be used solely to enhance the eSubmission process.
Survey start date: 20 August 2025
Survey end date: 30 September 2025
Source: eSubmission
Some recent updates to the CTCG Key documents list
| Document | version and last updated date |
|---|---|
| Initial application cover letter | Version 4, June 2025 |
| RFI Response List of Changes to the Application | Version 2 – June 2025 |
| FAQ document Frequently asked questions related to Clinical trials submitted under the Regulation EU 536/2014 | Version 1 – May 2025 |
Source: HMA
Forms for paediatric applications
The following forms are also available:
- Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion (Version 7 of August 2025)
- Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) – Re-submission following clock-stop (Version 1 of July 2025)
- Additional information – Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions (Version 1 of July 2025)
Source: EMA
Procedural advice on paediatric applications, guidance for applicants
The document with the above title has been updated to Revision 14 (August 2025).
In Rev. 14, the updates are:
- In section 6.2 there is clarification that new studies are not needed in a separate KEF form.
- In section 9 there is clarification that using key element form is not mandatory if it was already submitted in IRIS.
Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
The document with the above title has been updated to version 2.4. Here you can view the track changed and clean versions of the document.
eCTD v4.0 – Controlled Vocabularies v2 (.xlsx format) now available
A new version of the EU eCTD v4.0 controlled vocabularies (v2) is now available, in excel (.xlsx) format.
The genericode (.xml) format will be published soon.
The few changes compared to the previous version are highlighted in the document, and marked with new/updated, accordingly.
This version of the controlled vocabularies contains the new OID of the Implementation guide (1.3), which will also be published in the upcoming weeks.
Source: eSubmission
PSURs can only be submitted with IRIS-affiliated contact from 1 September 2025
As of 1 September 2025, Marketing Authorisation Holders (MAHs) will no longer be able to create PSUR submissions if the primary contact indicated in the PSUR submission form does not have an IRIS account affiliated with the MAH of the product.
To ensure business continuity, all MAHs are strongly encouraged to verify that their contacts meet this requirement well in advance of the deadline.
Please note the following:
- For Centrally Authorised Products (CAPs): For any type of procedure with CAPs, it is a CAP Person authorised for communication with the Agency (referred in section 2.4.3 of the application form).
- For non-CAPs: For PSURs with non-CAPs, the MAH contact associated with the email address as indicated in the PSUR submission form (and NOT in the cover letter) when generating the delivery file.
All key actions and instructions for updating product contacts and requesting IRIS access are explained in the PDF document available on this page, which also includes an overview of training resources for MAHs for using IRIS and EMA service desk triage guidelines for support requests.
If you have questions outside of the above or require further assistance, please raise a ticket through the EMA Service Desk.
Source: eSubmission
EU eCTD v4.0 validation criteria first version published
The EMA eCTD team and the EU eCTD v4.0 Subject Matter Experts are pleased to announce that a draft EU eCTD v4.0 validation criteria is now available here.
- The list is a combination of rules existing in eCTD 3.2.2 (adapted to the new standard, where necessary), and new rules, extracted from the eCTD v4.0 specification, mainly related to the schema (for example mandatory elements and attributes).
- The EU eCTD v4.0 validation criteria complements the latest eCTD v4.0 ICH validation criteria.
- The list is focused on the centrally authorised products (CAPs) and will be further edited to contain rules for MRPs, DCPs and NAPs
- eCTD tool vendors are encouraged to start implementing the rules, in preparation for the optional use of eCTD v4.0 for CAPs, planned for late Q4 2025.
- The scope of the optional use and the actual start date depend on the results of the ongoing eCTD v4.0 technical pilot, and will be communicated in Q4.
Source: eSubmission