Last updated: 28 April 2025
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eAF v1.27.0.1 (Human Variation) now available, for use from 1 May 2025
A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website.
- The version:
- can be used starting with 1st of May 2025.
- 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: eSubmission
PSUSA procedures: new requirement for Word version of the PSURs and RSI responses
When submitting PSUR or RSI responses for a PSUSA procedure, the marketing authorisation holders (MAHs) are also required to systematically provide Word versions of the submitted PSURs and RSI responses, as part of the Working Documents folder.
Reminder
When submitted with an eCTD, the Working Documents should always be provided in a separate folder called “xxxx-workingdocuments” on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.
Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence “0007”, which contains working documents, the separate folder should be named “0007-workingdocuments”. More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD – version 6.0.
More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD – version 6.0.
Source: eSubmissions
Updated Q&A – European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (Feb 2025) and clean (March 2025) versions of the document.
In 2025, there are changes in the following section: 1-6, 17, 19 and 23.
Updated Assessment Report (AR) templates for paediatric studies:
- UPDATE – AR template for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006
- UPDATE – AR template for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006
- UPDATE – AR template CMS Comments on LMS’s Preliminary Assessment Rep
Source: HMA
Update on web-based Human variations electronic Application Forms (eAFs) timeline
The EMA would like to provide you with an update on the progress of the web-based Human variations electronic Application Form (eAF) implementation on the Product Lifecycle Management (PLM) Portal.
- During Q1 2025 – It was announced that the human variation web-based eAF was open for first use for non-Centrally Authorised Products (non-CAPs) through the PLM Portal, allowing Marketing Authorisation Holders to use the web-based application form for all EU variation procedures, including submission to the NCAs.
Key points from the updated timeline:
- Q2 2025:
- Recommended use of Human variation eAF for non-CAPs*.
- Continue the incremental release of the new UX design and the incremental release of new features, including maintenance and optimisation updates and performance improvements.
- Q3 & Q4 2025
- Strongly Recommended use of Human variation eAF for non-CAPs*.
- Exploration of structured changes in eAF.
Source: eSubmission
European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance
Revision 16 (26 March 2025) of the above guidance has been published. You can view it here.
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 1.2.0.2 released to production on 31 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.
Report and minutes from the CMDh meeting held on 25-26 March 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 and minutes from the above meeting include (but are not restricted to) the following items:
1. Chapter 9 – CMDh Best Practice Guide on fast track procedure for the annual strain update of human influenza vaccines
The CMDh has agreed a minor update of the BPG on fast track procedure for the annual strain update of human influenza vaccines. The term “annual update” has been replaced by “annual strain update” to avoid confusion with the annual update of type IA variations.
The updated document has now published on the CMDh website under “Procedural Guidance > Variation”. Here, you can view the track changed (July 2023) and clean (March 2025) versions of the document.
2. Electronic Submission
The EMA informed the CMDh about the introduction of an ‘integrity stamp’ in the PLM Portal web based eAF for variations.
- This stamp is automatically included when the form is finalized and can replace the signature, ensuring the form’s authenticity.
- Forms that have not been finalised (i.e. do not contain the integrity stamp) will be rejected in future by the regulators.
- It was noted that some applicants face compatibility issues and while the stamp is seen positively, more information and experience are needed before setting a reasonable deadline.
- MSs will review the table on national requirements for variations and renewals in eCTD format to identify possible updates.
- The EMA presented some additional changes to the eAF for MSs to consider and send comments as necessary.
3. Usage patents
The CMDh discussed proposed deletions of patent-protected parts in the SmPC and PL of generic DCP applications during the national phase.
- The applicant proposed deletions in sections 4.1, 4.8, and 5.1 due to patent protection on one of the indications of the Reference Medicinal Product (RefMP).
- It was noted that from a public health perspective that it is necessary to keep all safety-related information up to date in the PI, even if individual indications are not included.
- While information on patent-protected indications can be omitted in sections 4.1, 4.2, and 5.1, as appropriate, other clinical sections should retain the originator’s information.
- The proposed deletion of information in section 4.8 was not supported by CMDh.
- Some MSs confirmed that they also received and refused similar requests to delete information in section 4.8.
- The CMDh agreed to keep all safety-related information, aligning with above MSs approach and Q&A 4 of the CMDh Questions & Answers on Usage Patents
IRIS guide to registration and RPIs
The updated version of the above guide Ver 2.17 (28 March 2025) has been published. YOu can view it here.
Source: EMA
UPDATE – List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
The updated list has been published. You can view it here.
Source: HMA