Last updated: 16 May 2025
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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 version 1.2.0.4 released to production on 13 May 2025 are now available on PLM Portal and on the PLM Portal eAF web page.
Additionally, the PLM portal FHIR XML version was updated to 2.2.2. The new version introduces the following change: there is a new element in the Organisation, called “alias”, which contains (if existing) the selected alternative company name: <alias value=”alternative company/organisation name” />
The Release notes can be found here.
Source: eSubmission
External guidance on the implementation of the European Medicines Agency Policy 0070 on the publication of clinical data for medicinal products for human use
Version 1.5 of the above document (May 2025) has been published. You can view a summary of the changes in this document.
Policy 0070 entered into force on 1st January 2015. Phase 1 of the policy pertains to publication of clinical reports only. Clinical reports and IPD are collectively referred to as “clinical data”. This guidance has been prepared to assist applicants in preparing packages for publication and the general principles applied.
Source: EMA
Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders
This guidance in the format of a Q&A supplements the data requirements in the published guidelines on PMF scientific requirements (EMEA/CHMP/BWP/3794/03) and dossier requirements on PMF epidemiological data (EMA/CHMP/BWP/548524/2008) on topics related to information on blood establishments and blood/plasma centres (BE/BCs) to be included in the PMF as well as listing of prospective BE/BCs in Annex II of the PMF.
This Q&A describes the approach to be applied in the evaluation of the compliance of BE/BCs registered in PMF applications, with the aim to improve and harmonise the PMF content at submission and consequently to streamline the PMF certification and evaluation timelines.
Source: EMA
eAF v1.27.0.1 (Human Variation, interactive PDF) now available, for use from 1 May 2025
A new version of the interactive PDF Human Variation eAF v.27.0.1 was published on 6 May 2025, bringing a small change in the exported XML data. No other changes are introduced. It is highly recommended to use this latest version of the form.
Reminder:
- A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website. The version should be used starting from 1 May 2025.
- The version allows the selection of Reference Member State and Concerned Member State(s) when the type of authorisation is ‘National Authorisation’ and the type of application is ‘Super-grouping’.
- It is mandatory to use version 1.27.0.1 for all new Human Variation procedures.
- The version 1.27.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for ongoing procedures.
- Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
Source: eSubmissions
SPOR status update
This webinar held on 4 April 2025 provides a status update on SPOR (Substances, Products, Organizations and Referentials data) and XEVMPD (Extended EudraVigilance Medicinal Product Dictionary).
Here’s a breakdown:
- Webinar Logistics: The session is recorded and available on the EMA website and YouTube channel [00:35]. Participants can ask questions via Slido using a provided code [01:12].
- SPOR and XEVMPD Overview: The webinar explains how SPOR, XEVMPD, and PMS (Product Management Service) fit together [04:20]. Data entered in XEVMPD is synchronized with PMS and shared with other processes [06:07]. If you need any substance, organization, referential data, you should request it in SMS and RMS ahead of XEVMPD submissions [06:36].
- Webinar Structure: The agenda includes updates on SMS (Substance Management Service), MS (Organization Management Service), RMS (Referentials Management Service), XEVMPD, and PMS [04:41]. Each topic has a short presentation followed by a Q&A session [04:49].
- Feedback and Improvements: The EMA seeks feedback on the webinar format and content [07:40]. They also conduct a customer satisfaction survey [08:13]. Suggestions include running the survey for a longer period [12:12].
- Substance Updates: There will be more substances with SVG flag zero in the future [23:09]. Changes to substance preferred terms are currently on hold due to potential impacts on pharmacovigilance activities [23:31].
- Synchronization Issues: EMA is analyzing synchronization issues between XEVMPD and PMS and working on implementing reporting to track it [02:18:48].
- Pharmaceutical Form Terms: Non-current terms in RMS without a current replacement in XEVMPD are maintained unless the National Competent Authority (NCA) wants to change them [02:19:47].
- PMS API Updates: Updates via the PMS API might be available later, potentially in 2026 [02:21:11]. Data submitted through the PMS product UI will be available in the PMS API [02:21:54].
- Webinar Feedback: The EMA acknowledges feedback about the webinar being information-heavy and is exploring ways to improve, such as shorter, crisper sessions with additional webinars for in-depth discussions [22:34].
- Upcoming Event: The next event is the PMS info day [23:33].
Public System Demo Q1 2025
This webinar was held by the EMA on 26 March 2025. Time stamps are provided below.
00:00:00 – Welcome / Introductions
0:05:19 – Data Analytics Platform (DAP) – Trial Map
0:26:05 – Product Management Services (PMS) and Product User Interface (PUI)
1:07:59 – Electronic Product Information (ePI)
1:37:59 – Electronic Application Form (eAF)
2:02:51 – Union Product Database (UPD)
2:17:30 – Closing remarks and date of next demo
Source: EMA
Report and minutes from the CMDh meeting held on 23-24 April 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 includes (but is not restricted to) the following items:
1. Public consultation on QRD template version 11 and package leaflet key information
EMA is inviting all interested stakeholders to comment on a public consultation on version 11 of the quality review of documents (QRD) template and on the potential inclusion of a ‘key information section’ in the package leaflet of centrally authorised medicines.
- The CMDh would like to encourage stakeholders to comment bearing in mind that the QRD template for MR/DC procedures is based on the QRD template for centrally authorised medicines.
- The deadline for comments is 31 May 2025 for the package leaflet key information and 31 August 2025 for the QRD template v11.
- The public consultation documents and instructions for submitting comments are available on the EMA website.
- Alternatively, you can view further information on this page of the blog under the section Consultations – Medicines
2. Template for Request for MRP/RUP
Following the implementation of the new Guideline on the environmental risk assessment of medicinal products for human use, MRP/RUP requests submitted until 31 March 2025 had the possibility to provide a commitment to submit a variation within 3 months after end of MRP/RUP, in case the ERA provided in Module 1.6 was not in line with the current version of the Guideline.
- Considering that this deadline has now passed, the CMDh agreed an update of the template for Request for MRP/RUP to delete this option and further clarify that if the dossier does not contain a Module 1.6 or the ERA provided in Module 1.6 is not in line with the current version of the Guideline, a variation has to be submitted to add/update Module 1.6 prior to the MRP/RUP.
- In line with the above, a similar statement has been included with regard to the RMP requirement.
- The updated template has now been published on the CMDh website under “Templates > MRP/RUP”
- Here, you can view the track changed (September 2024) and clean (April 2025) versions of the template