Last updated: 1 July 2026
To view updates, click on the + sign below:
IRIS guide for applicants updated
The above guide on how to create, submit and manage IRIS applications, centralised product contacts for industry and individual applicants was last updated on 9 June 2026.
Source: EMA
Committee for Advanced Therapies (CAT) rules of procedure
The document with the above title was last updated on 16 June 2026. The date of entry into force is 1 July 2026.
Source: EMA
Meeting with Interested Parties – 25 June 2026
You can view the agenda for the meeting here.
Below are the links from the individual presentations in the meeting:
- CMDh – CTS Overview
- CMDh – MAWP
- EUCOPE – DCP Slot Booking
- CMDh – Slot Booking
- EUCOPE – Variations
- EFPIA – Variations Worksharing – Concerns the following
- i) RMS selection
- ii) Adherence to timetable
- iii) Partial approvals issued by some RMSs
- iv) Grouping of Type IA/IAIN variations
- v) Submission of type IA variations annual report
- CMDh – FAQs on Revised Variations Regulation and Classification Guideline from Industry
- EUCOPE – Environmental Risk Assessments (ERA) Experience & Challenges
- MfE – CEP 2.0
Source: CMDh
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 1.2.1.12 and 1.2.1.13 (the most recent one released to production on 22 June 2026) is now available on the eSubmission PLM Portal eAF web page.
and
PLM Portal FHIR XML version upgrade to 2.2.6 on 6 July 2026 18:00 CET
The PLM portal FHIR XML version will be updated to 2.2.6 on 6 July 2026, 18:00 CET. The new version introduces the following change: the “Annual Update” notification will be reflected in the FHIR XML in the following existing extension:
<input>
<type>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/codeSystemName">
<valueString value="Procedure Detail Type" />
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000027891" />
<code value="200000060060" />
<display value="Annual update" />
</coding>
</type>
<valueBoolean value="true" />
</input>
The existing FHIR package remains applicable.
The Release notes can be found here.
Source: eSubmission
Eudralex Volume 4 Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 19 Reference and Retention Samples
The above has been revised and will become applicable from 24 September 2026.
Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee
jointly recommend that the current version of annex 19, on the Reference and Retention Samples, is revised with respect to reference and retention Samples for Parallel Imported/Parallel Distributed/Parallel Traded Products.
Source: European Commission
Human MAA eAF v1.28.0.0 – update on mandatory use for CAPs and new minor version available
Minor version 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application (Human MAA) is now available on the eAF website.
Industry must use the updated eAF, Version 1.28.0.0, for any new CAP MAA Human submission to EMA from 28 July 2026 onwards. For all other types of products, use of the updated eAFs is expected to become mandatory after 1 September, at a later date which will be announced after alignment with relevant stakeholders. The date and further transition details will be shared through the eSubmission website.
Source: eSubmission
TEAM NB Position Paper on IVDR Application and appropriate surveillance Transfer agreement
Team-NB members adopted a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates.
Source: TEAM NB
Clinical Trials Coordination Group (CTCG) key documents update
The CTCG template Initial application cover letter has been updated to Version 7, June 2026.You can view it here.
Source: HMA
Checklist for the submission of day 215 translations for post-opinion linguistic review – human
You can view the document with the above title here.
Member states contact points for translations review
The document with the above title has been updated. You can view Revision 7.1 (4 June 2026) here.
123rd Heads of Medicines Agencies (HMA) 24 February 2026, Virtual Meeting Meeting report
This report was posted on the HMA website on 3 June 2026. You can view it at this link.
Information from a couple of topics discussed at the meeting is provided below.
New pharma legislation update
- An update was given to the Members regarding the forthcoming New Pharma Legislation.
- This package provides a reform to the existing legislation. It includes regulatory sandboxes to pilot groundbreaking innovative therapies and the regulatory data protection voucher that allows the development of novel antimicrobial products, capable of fighting Anti-microbial Resistance and adapted frameworks with specific technical requirements tailored to the characteristics of certain novel medicines.
- A reference was made also to the strengthening of early regulatory support by EMA, particularly for promising medicines under development for unmet medical needs.
- Moreover, the reduction of the approval time of EMA scientific assessment time from 210 to 180 days (150 for accelerated) the limitation of clock stops during the screening of applications and the early termination of immature applications were also outlined.
- Other points were emphasised such as the simplification of the EMA structure and function, the streamlining of regulatory procedures, the possibility for EMA to review data in phases and the better use of expert resources for the authorisation/supervision of medicines.
- The use of real-world evidence and of health data for regulatory purposes, the Electronic submission of applications and the Electronic Product Information, are ways of important simplifications and new ideas relevant to the implementation of the package.
Electronic Product Information (ePI)
Electronic Product Information (ePI), referring to the authorised statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) in a harmonised electronic format, was presented.
- The background, rationale, legal context and scope of the initiative were outlined,
- including the expected legislative requirement for electronic product information for centrally and nationally authorised medicines and the development of a central repository hosted by EMA.
- The proposed draft ePI roadmap and the readiness assessment to support implementation across the EU regulatory network were endorsed.
- Next steps include follow-up work at the level of the Regulatory Optimisation Group (ROG), informing stakeholders of the agreed draft roadmap in Q2 2026, and assessing the readiness of NCAs during 2026.
- A workshop scheduled for 10 June 2026 will mark the start of the implementation phase. A final roadmap for ePI implementation, including timelines for NCAs to go live, is expected to be presented to the EMA Management Board and HMA in Q4 2026.
Human MAA eAF v1.28.0.0 now available for testing
Version 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application (MAA) is now available on the eAF website, together with the associated release notes.
- The changes made in version 1.28.0.0 for the Human MAA aim to address structural limitations in the current form and support alignment with the ISO Identification of Medicinal Products (IDMP) data model.
- As regulatory data management evolves, the eAF needs to support a more structured and interoperable representation of medicinal product information across the EU regulatory network.
- The proposed changes do not modify the regulatory intent or the type of information collected in the form.
- Rather, they improve how this information is structured and captured, enabling a more accurate representation of complex medicinal products and ensuring that key product attributes (such as product composition, packaging, manufacturing responsibilities and administration characteristics) can be described in a consistent and machine-readable way.
- Following the successful completion of internal user acceptance testing (UAT), EMA is now extending testing to a broader group.
- Marketing authorisation holders are encouraged to complete the form using real or mock data-preferably reflecting complex product compositions and packaging-and to report any issues as soon as possible, and no later than 9 June 2026 at 18:00 CET, by submitting a ticket via the Request information about eAF – interactive PDF – Employee Center.
- Please note that the form must be “trusted” before use.
- Subject to a successful testing phase, concluding on 9 June 2026, the form is expected to become mandatory from 1 September 2026.
- Further details regarding the mandatory transition will be communicated in due course.
Source: eSubmission
Links to EMA webinars
Report and minutes from the CMDh meeting held on 19-20 May 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 and minutes from the above meeting include (but are not not restricted to) the following items:
1. Template for the non-clinical and clinical assessment of a generic application in MRP/DCP
The CMDh agreed an update of the template for the non-clinical and clinical assessment of a generic application in MRP/DCP.
- The wording in relation to the environmental risk assessment has been aligned with the wording used in other templates.
- The updated template will be published on the CMDh website under “Templates > Assessment Reports DCP”.
A link will be provided here once the updated template becomes available.
2 New applications MRP and DCP started in April 2026
You can view the stats for the above on pages 3 and 4 of the report.
3. EC/EMA Operational Group on Combination Products and Consultation Procedures (COMBO)
The CMDh representative in the COMBO group reported from the COMBO meetings.
- COMBO was established to clarify and streamline applications and assessments concerning combination products and consultation procedures for medical devices.
- COMBO aims to provide a regular forum for dialogue, sharing experiences, achieving mutual understanding.
- The group is working on guidance, e.g. to enhance the role of Notified Body Opinions in
- complementing the quality assessment of MAAs or guidance to standardise and harmonise the assessment of medical devices with ancillary medicinal substances.
- Further updates from the work of the group will be given as the work progresses.
4. Update of Variation guidance documents in relation to deletion of requirement for
cover letters for type IA variations
Following the discussion in the April CMDh meeting, the CMDh agreed updates to several
CMDh guidance documents in relation to the deletion of the cover letter for Type IA variations.
It was agreed that the change can be implemented from 1 July and therefore the
updated guidance documents will be published on the CMDh website after the June CMDh
meeting. The eAF and CESP delivery file are being updated in parallel.
5. Procedure for the preparation of the annual report to update the EC Variations
Guidelines
The CMDh discussed and agreed on a procedure for preparing the annual report to update
the EC Variations Guidelines in accordance with Article 4 of the Variations Regulation. This
process may be revised as further experience is gained. EMA will circulate the final document
to CMDh.
6. Submission of parallel national variations instead of worksharing
The CMDh was informed about a Type II safety variation application submitted via parallel
national variations in different Member States instead of a single worksharing procedure.
- The CMDh noted that the applicant failed to declare this information in the eAF.
- The CMDh agreed that Member States should inform the applicant that they should withdraw their parallel national applications.
- The changes should be submitted via variation worksharing in accordance with the revised Variation Regulation.
- The worksharing procedure could then follow a shortened timetable for a timely and harmonised implementation of the safety changes.
- MAHs are reminded to make use of the mandatory worksharing.
7. GMP / GDP
Following the implementation of the provision in the EU-US MRA allowing to rely on certain
non-domestic US FDA inspections, the CMDh agreed in November 2025 that the Supervisory
Authority (GMP inspectorate) responsible for inspecting a third country site should be
consulted by the RMS to determine if and to what extent an FDA inspection could be used to
confirm the GMP compliance status of the third country manufacturer.
- In order to optimise this process, the CMDh agreed to prepare a list of contact points and email addresses for such questions to the inspectorates. Member states were asked to fill in the information in the document included in SharePoint by the end of May 2026
- In addition, the CMDh agreed to use standardised wording and tick boxes to facilitate contact with inspectorates.
8. Electronic Product Information (ePI)
An update was presented on the electronic Product Information (ePI), including the use of PLM portal, the provisions in the New Pharmaceutical Legislation (NPL) and the draft implementation roadmap.
- Under the NPL, package leaflets will be required to be made available electronically (ePI).
- This requirement will apply to all new medicines from the date of entry into application and to existing medicines within three years thereafter.
- In addition, a new obligation introduces the use of English for all package leaflets, including those for purely nationally authorised products.
9. Acceptability of reference medicinal product purchased from the UK/third countries
The CMDh discussed the acceptability of a EU reference medicinal product batch released in
EU and purchased in the UK used for a BE study.
- The MAH has confirmed that the product is sourced from the EU and has provided documentation on the supply route to support their claim.
- The CMDh agreed that, in this case, the product is sourced from within the EU and, therefore, can be considered as a reference medicinal product for the bioequivalence study.
- Some Member States highlighted the need for clearer CMDh guidance on the interpretation of RefMP purchased (sourced) in the UK.
- The post-Brexit Questions & Answers document will be reviewed to consider whether an update of the guidance is needed.
- The CMDh also discussed a question from MfE on the subject of allowing reference products from outside the EEA.
- However, deciding on such a change in policy was considered outsideof the remit of the CMDh.