Last updated: 05 February 2026
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Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders
This Q&A was updated on 19 January 2026 due to Editorial deletion of Section Alert limits Q.8 and 9 consequence of CHMP adoption of Draft chapter 9 of guideline on epidemiological data on blood transmissible infections.
You can access the Epidemiological data on blood transmissible infections – Scientific
guideline | European Medicines Agency (EMA) here.
Report from the CMDh meeting held on 27-28 January 2026
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. Guidance on the application of the revised variations framework
Handling of type IA variations not submitted before 15 January 2026
On 15 January 2026, the new Variation Guidelines (including updated variation classifications) came into force.
- All variations submitted after this date should follow the new guideline.
- If, unexpectedly, a MAH identifies one or more Type IA variations that were implemented before 15 January 2026 but not submitted by that date, the delayed Type IA variations should be submitted promptly and without any further delay as an “early annual update”, using the old eAF and in accordance with the previous (2013) classification guideline.
- The MAH should ensure that all Type IA variations that were implemented before 15 January 2026 are included in this submission.
- Further guidance on the application of the revised variations framework can be found on the CMDh webpage and in this blog post.
2. Questions and Answers on generic applications
The CMDh has agreed an update of the CMDh Questions and Answers on generic applications. Q&A 8.b. has been reviewed to clarify the requirements on compatibility and administration of generic medicinal products via enteral tubes.
The updated document will be published on the CMDh website under “Questions and Answers”.
A link will be provided here once the updated document becomes available.
3. The worksharing procedure for the assessment of Active Substance Master File (ASMF)
The CMDh has agreed an update of the guidance document on worksharing procedure for the
assessment of Active Substance Master File (ASMF) prepared by the ASMF WG.
The document was revised:
- to delete references to the ASMF summary
- clarify that national procedures should be also included in the repository,
- add references to the Q&A document on ASMF and
- to bring it in line with the revised EC Variations Guidelines.
The updated document will published on the CMDh website under “CMDh > CMD Working Parties / Working Groups > Working Group on Active Substance Master File Procedures”.
A link will be provided here once the updated document becomes available.
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (Dec 2025) and clean (15 Jan 2026) versions of this document.
The bulk of the track changes appear to be in the section 7 Classification of changes with an updated date of November 2025.
Source: EMA
Validation Checklist for Type II (non)clinical variations
You can view the checklist here.
The checklist should be completed and submited it as a word document as part of the working documents with your application for type II clinical, non-clinical and RMP variations
Source: EMA
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 1.2.1.4 released to production on 19 January 2026 is now available on the eSubmission PLM Portal eAF web page.
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026/2027
You can view the document with the above title, here.
Source: EMA
Factsheet – Revolutionising Clinical Trials
You can view the factsheet here.
Source: European Commission
Decentralised Procedure – Requests to act as RMS
The document with the above title has been updated (Jan 2026). You can view it here.
Source: HMA
European Shortages Monitoring Platform (ESMP) update: Expansion in progress | ESMP webpage reorganisation | New ESMP factsheets and updated FAQs
As part of EMA’s ongoing commitment to enhance the European Shortages Monitoring Platform (ESMP) and support its users, the ESMP is expanding with new functionalities, and the development work is progressing. In addition, new and revised support materials are now available on the ESMP webpage, which has been reorganised with some content moved to two dedicated subpages.
ESMP expansion
The ESMP is expanding to include new tools and features that will better support stakeholders in preventing, managing, and mitigating medicine shortages:
- Voluntary solidarity mechanism workflow (for Member States): Implementation of a data submission and management workflow in the ESMP that allows Member States to flag critical national shortages of specific medicines, enabling other Member States to indicate available stock that could potentially be redistributed.
- Critical shortage reporting workflow (for Member States): This feature builds on the current reporting of critical shortages by NCAs to EMA and streamlines the submission and management of critical shortage notifications.
- Vulnerability assessment methodology testing (for the MSSG): In line with the upcoming pharmaceutical legislation reform, this functionality will support the MSSG in testing and automating a new methodology to identify vulnerabilities in the supply chains of medicines. It will allow step-by-step testing and provide initial large-scale analysis using defined indicators.
New ESMP webpage subpages
The ESMP webpage content has been revised and some content reorganised into two dedicated subpages:
- ESMP guidance, training materials and events page – hosting all user and implementation guidance, training materials and information on ESMP events.
- ESMP interoperability page – focused on information on the platform’s interoperability with national and pharmaceutical industry systems.
New and updated resources
To further support stakeholders in fulfilling their reporting obligations new concise factsheets and updated FAQs are available:
- ESMP Factsheets: four one-page summaries of MAHs and NCAs reporting obligations and processes in times of routine shortages, crises, or MSSG-led preparedness actions.
- ESMP FAQs: revised and expanded, with update details available in the revision history table.
Source: eSubmission
Overview of timetables 2026 CMDh 60-day procedures for MRP/DCP applications
You can view the overview of timetables here.
Source: HMA