Last updated: 4 June 2026
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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
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 1.2.1.11 released to production on 26 May 2026 is now available on the eSubmission PLM Portal eAF web page.
Source: eSubmission
Links to EMA webinars
Report 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 from the above meeting includes (but is 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.