Last updated: 1 April 2026
To view updates, click on the ‘+’ sign below:
Updated EU Commission Q&A guidance on EU Clinical Trials Regulation (CTR) and revised versions of several Clinical Trials Coordination Group (CTCG) templates
An updated version (v7.2 of 27 March 2026) of the EU Commission Q&A guidance on EU CTR a well as revised versions of the following CTCG templates have been published:
Cover letters and RFI Response
Initial Applications
- Initial application cover letter | docx – Version 6, March 2026
- Part II placeholder document Article 11 workaround | pdf – Version 1.0, March 2026 (see Article 11 guidance for sponsor below)
Substantial Modification (SM)
- Cover letter | docx – Version 4, March 2026
- Modification description | docx – Version 3, March 2026
CTIS Guidance
- Best practice guide naming of documents in CTIS | pdf – Version 3, March 2026
Sponsor guidance on Article 11 workaround
- Guidance for sponsor on Article 11 workaround | pdf – Version 1, March 2026MSC intended to receive part I only initial submission – procedure applies from April 27 2026
Source: HMA (in the section Key documents list)
103rd meeting of the Pharmaceutical Committee, 27 March 2026
Accompanying the agenda for the above meeting were the following three documents:
All three topics are included in the proposed new pharmaceutical EU legislation. Here, you can view the latest versions of proposed new Directive and Regulation.
- Each of the three documents is meant to give a general overview of the agreement reached between the co-legislators.
- While the content is final, certain details, such as legal references cited in each document, may still change after the linguistic check of the file and therefore may differ slightly from the official versions of the two acts which will be published in the EU Official Journal.
A link to the summary record from the meeting will be provided here once it becomes available here.
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Here, you and view the tracked changed (Dec 2025) and clean (Mar 2026) versions of the above document.
The answer to the following question has been updated:
5.1.1. How long does it take for my application to be evaluated? Rev. Dec
Mar 2026
Source: EMA
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you and view the tracked changed (Jan 2026) and clean (Mar 2026) versions of the above document.
Responses to all of the following questions have been updated except for Questions 17.31 and 22.12 which are new questions
- 1.1. When shall I submit my Type IA/IAIN variation(s)?
- 1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?
- 2.4. How shall I present and submit my Type IB Variation?
- 3.11. How shall my Type II application be handled (timetable)?
- 3.21. Do I need to confirm the maintenance of my orphan designation when applying for a Type II variation?
- 3.24. Do I need to address any paediatric requirements in my Type II variation application?
- 4.1. When will my variation application be considered a Type II variation or an extension application?
- 4.7. Do I need to confirm the maintenance of my orphan designation when applying for an extension application?
- 4.15. When do I have to submit revised product information? In all languages?
- 5.2. What groups of variations would be considered acceptable?
- 5.3. How shall I present a grouped variations application?
- 6.5. How and to whom shall I submit my variation application under
- 6.10. When do I have to submit revised product information? In all languages?
- 7.4.1. What can be considered an editorial change and how can it be submitted as part of a Type IA/IB/II variation?
- 13.10. How shall I implement the outcome of a non-interventional imposed PASS final study report procedure?
- 14.2. How and where the PAES imposed in accordance with the Commission Delegated Regulation will be reflected in the marketing authorisation?
- 14.4. When should I submit my imposed PAES protocol?
- 15.8. When shall I submit my PAM?
- 15.9. Under which procedure should I submit my PAM?
- 15.14. How are PAMs enforced?
- 16.4. Which variation classification will apply for my RMP updates?
- 16.6. Can I group my RMP updates?
- 16.9. Can I submit a version of the RMP after the Opinion to reflect the last-minute changes made during the CHMP?
- 17.13. Do I have to submit a PSUR if my medicinal product is authorised in accordance with Article 58 of Regulation EC No. 726/2004 (EU-M4all)
- 17.30. How shall I implement the outcome of a PSUSA procedure?
- 17.31. Can I extrapolate the PRAC recommendation on a PSUSA to medicinal products not included in the procedure?
- 18.3. How shall I present my article 46 paediatric study application at submission?
- 19.1. What is a Transfer of Marketing Authorisation?
- 19.2. How shall I present my application for the Transfer of Marketing Authorisation?
- 19.7. How to handle planned/ongoing variations procedures during the Transfer of Marketing Authorisation?
- 19.9. Do I have to submit mock-ups and specimens?
- 19.13. Can I change the name of a medicinal product as part of a transfer application?
- 22.1. What is an Article 61(3) Notification?
- 22.4. How shall I present my 61(3) Notification?
- 22.8. Do I have to submit mock-ups and specimens?
- 22.12. How to present mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorized medicinal products submitted via a 61(3) Notification?
Source: EMA
Tables of non-standard abbreviations in SmPCs and small immediate packaging labelling only
You can view the tables here.
Source: EMA
Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products – General principles of acceptability and rules of procedure
You can view Rev 2 (of 23 March 2026) of this document here.
Source: EMA
Launch of eCTD v4.0 pilot phase III on forward compatibility for Centrally Authorised Products
The European Medicines Agency (EMA) is pleased to announce the start of the eCTD v4.0 pilot phase III on forward compatibility for Centrally Authorised Products (CAPs).
- The planned initial duration of this phase is two to three months, with the possibility of extension if needed.
- Below is an overview of the:
- 1. Scenarios in scope of the pilot
- 2. How to participate in the pilot phase III
- 3. Step-by-step process for applicants
- 4. EMA Responsibilities
1. Scenarios in scope of the pilot
- Scenario 1: Transform to eCTD v4.0 during an Initial Marketing Authorisation Application (MAA)
- Scenario 2: Transform to eCTD v4.0 at the start of a post authorisation activity
- Cross application scenarios: Document Reuse
2. How to participate in the pilot phase III
- Pre-requisite for participation: Prospective participants should have a Centrally Authorised Product with an existing lifecycle for which they intend to submit eCTD v4.0 sequences.
In case applicants do not have a Centrally Authorised Product with an existing lifecycle but do wish to participate in the pilot, they are invited to contact the EMA eCTD team via e-mail (eCTD4consultation@ema.europa.eu) for specific instructions.
3. Step-by-step process for applicants:
- Contact the EMA eCTD team via e-mail (eCTD4consultation@ema.europa.eu) by 10 April 2026 to register and request to have the test environment added into your eSubmission Gateway account.
- Provide the routing ID of your eSubmission Gateway.
- Identify the UUID of the product for which you intend to submit the eCTD v4.0 sequences and provide the EMA with details of the selected product (EMEA/HC number, sequence number, submission type and unit per sequence number).
- Create the Delivery File for the current eCTD(s) v.3.2.2 in the production environment.
- Submit the v.3.2.2 submission package to the test environment.
- Ensure that you have received successful acknowledgment for the v.3.2.2 package before proceeding.
- Submit a technically valid eCTD v4.0 package to the test environment.
4. EMA Responsibilities
- Confirm applicant acceptance into the pilot.
- Add new ‘test’ environment to the applicant eSubmission Gateway account.
- Provide the Delivery File for the eCTD v4.0 follow-up submission unit to the applicant.
Points for Consideration
- It is not mandatory to include all previous eCTD sequences in the pilot. The applicant is responsible for deciding how many sequences to include.
- Test documents may be used in the follow-up eCTD v4 submission unit.
- If test documents are included, the scenario(s) must be clearly described in the cover letter.
In case of any questions regarding participation or technical requirements, please contact the EMA eCTD team at eCTD4consultation@ema.europa.eu.
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 1.2.1.7 released to production on 16 March 2026 is now available on the eSubmission PLM Portal eAF web page.
Source: eSubmission
IRIS guide for applicants
You can view the latest version (3.13, March 2026) of the guide here.
Updated sections:
2.16. Products – Research Product Identifiers (RPI)
4.3.5. Clarification on scientific advice – human
Source: EMA
EU-Innovation Network guidance on available scientific and regulatory support tools at national and European level for human medicinal products/technologies/methodologies
Iterative interaction with medicines regulators provides an opportunity to optimize the development of new or existing medicinal products, orientating developers towards the most suitable guidance to comply with regulatory requirements, with the aim of ultimately leading to a marketing authorisation and access to safe, effective and high-quality medicines for patients.
- Interaction is foreseen and encouraged at both national and European level.
- The European Medicines Regulatory Network (EMRN) is working to raise awareness and encourage use of its supports for medicine development, with National Competent Authorities (NCAs) promoting access to supports for researchers and developers at national level, as well as providing information on and encouraging use of supports offered at European level via the European Medicines Agency (EMA).
- To this purpose, this guidance aims to help the researchers and developers to identify the most appropriate support tools to use during the medicinal product’s development.
- The guidance contains info boxes that provide manageable, concise and easily understandable descriptions of the regulatory support tools, including their scope, optimal timing in relation to the product development maturity and output.
- This guidance should be considered along with the glossary of regulatory terms embedded in the document and/or already available information at EMA and/or NCA websites.
- The regulatory and support tools described in this guidance are complementary to each other.
- In order to gain the best support from regulators and to optimise time and resources, it is recommended to consider the nature of the product, its development phase and the scope / intended use of the advice or guidance needed to choose the most appropriate tool on each occasion.
- For example, for questions related to the suitability of the design of a clinical trial to generate data to support a centralised marketing authorisation, EMA scientific advice would be recommended, while in very early development stages of innovative products/methodologies/technologies an innovation meeting (either at national or EMA level) may be a more suitable option.
Source: HMA
EU eCTD v4.0 validation criteria v1.1 published
Following the consultation period, the final version of the EU eCTD v4.0 Validation Criteria v1.1 is now available.
- The file includes the updated set of rules as well as a separate spreadsheet that highlights all changes and the file structure and names recommendation.
- eCTD v4.0 tool vendors may now begin implementing the new rules, and the updated validation criteria will become applicable starting 15 July 2026.
For any concerns, recommendations or questions, please send an email to ectd4consultation@ema.europa.eu.
The EMA team, together with the EU eCTD v4.0 Subject Matter Experts, will centralise and analyse the requests, and if considered valid, will include them in the following version of the validation criteria.
Reminder
- Applicants are invited to submit new Marketing Authorisation Applications (MAAs) for Centrally Authorised Products (CAPs) in eCTD v4.0 format.
- To ensure that enhanced support is provided and that the assessment team is aware, applicants must contact the EMA eCTD v4.0 team (eCTD4consultation@ema.europa.eu) prior to any eCTD v4.0 submission.
Source: eSubmission
Report and minutes from the CMDh meeting held on 24-25 February 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 restricted to) the following items):
1. Update of overview of biological active substances of nonrecombinant origin
The CMDh agreed an update of the overview of biological active substances of non recombinant origin.
- The document has been transferred into excel format, simplified and updated with biological active substances of non-recombinant origin, which have been authorised since the last update. You can view it here.
- The overview has previously been accessible via a link from the CMDh Q&As on biologicals.
- To increase visibility, the CMDh agreed to publish the updated document directly on the CMDh website under “Questions and Answers”.
2. MRP/DCP statistics in 2025
You can view the slide deck with Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures in 2025 here.
3. New applications in the MRP and DCP started in January 2026
At this link you can view the stats (tabulated on pages 3 and 4 of the report) as bar charts.
4. Working Party on Variation Regulation
i) Proposal to remove the requirement for a cover letter for Type IA/IAIN variations
The WP discussed the ROG proposal to remove the requirement for cover letters for type IA
variations.
- Some technical aspects need to be implemented before the cover letter can be
- deleted (minor changes to the CESP delivery file, update of eAF, work-around for mandatory cover letter in eCTD).
- For the implementation, a Q&A will be prepared to explain the correct completion of the delivery file and to explain that the requirement of the cover letter as mentioned in the variations guidelines will not be applicable anymore for type IA/IAIN variations.
ii) Annual variations guideline update
With regard to the Variations Guidelines, the WP was informed that EMA will draft a
procedure for the annual guidelines update laid down in Article 4 of the Variations Regulation
and the collection of the necessary updates to be included in the guidelines. Corrections in
the eAF/PLM should be communicated to the EMA contact person.
iii) Possible grouping of related type IA with IAIN variations outside the annual update of Type IA variations
The WP discussed again a possible grouping of related type IA with IAIN variations outside
the annual update of Type IA variations.
- A majority of the WP proposed to update Chapter 6 to allow grouping of type IA with IAIN for “related” changes, similar to the EMA.
- The update should include a non-exhaustive list of examples and guidance that not related changes will be invalidated without any option to correct the submission. The decision on the validation, if the changes are related, is left to the RMS.
- The CMDh agreed with the proposal.
- An update of the BPG will be prepared for the next meeting.
iv) How to handle cases when the present/proposed table of a type IA annual update variation application shows additional changes not covered by the variation(s)
The WP discussed how to handle cases when the present/proposed table of a type IA
annual update variation application shows additional changes not covered by the variation(s)
submitted.
- The CMDh agreed by majority that a type IA submission is a one-way process and no updates can be done.
- The annual update can be approved but the changes related to the missing variation codes have to be deleted from the dossier and resubmitted in a new single or grouped type IA variation (as they cannot wait for the next annual update due to the implementation time).
v) Proposal for update of the EMA/CMDh explanatory notes on variation eAF (human only) to include an example of how the products should be listed in the table “Products concerned by this application
The WP agreed a proposal for update of the EMA/CMDh explanatory notes on variation eAF
(human only) to include an example of how the products should be listed in the table
“Products concerned by this application” in alphabetical order.
The update will be included in the next scheduled update of the guidance in Q2. The update was also agreed by the CMDh.
vi) How to handle nitrosamine risk assessment reports included in nonrelated variation submissions.
The WP discussed how to handle nitrosamine risk assessment reports included in nonrelated variation submissions.
- It was agreed that the nitrosamine risk assessment should not be included and will not be considered in type IA variations within or outside the annual updates.
- In such cases, a note should be added in the approval letter for type IA variations that the risk assessment was not considered in the procedure, that the assessment needs to be removed from the dossier and has to be submitted separately according to the available guidance on nitrosamines.
- In type IB and type II variations, a justification needs to be included why the risk assessment is part of that variation or it should be deleted from the dossier.
- Normally, no variation is required for the submission of a risk evaluation.
- MAHs should consider the correct handling of step 2 and step 3 according to available nitrosamine guidance.
vii) Can an update of the combined product information in only two MSs
of an MRP/DCP be submitted as variation worksharing?
The WP discussed whether an update of the combined product information in only two MSs
of an MRP/DCP can be submitted as a worksharing update of the combined product information in only two MSs of an MRP/DCP can be submitted as variation worksharing..
It was agreed that the update of national versions of combined product information cannot be submitted as a worksharing variation.
5. Reference to CEP number and CEP revision number in individual eCTD sections
Following a question raised by a company, the CMDh discussed the guidance provided in Q&A
3.2 (General for all sections) of the QWP Questions and answers (Q&A): how to use a CEP in
the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation
Variation (MAV).
- The CMDh agreed that including the CEP number and its revision number in every CTD section 3.2.S does not provide additional value.
- The CMDh agreed to request that the QWP consider this position in the next revision of the guidance
6. Post-authorisation procedural advice for users of the centralised procedure
Following the publication of Q&A 7.3.1 in the European Medicines Agency post-authorisation
procedural advice for users of the centralised procedure, which addresses the impact of
changes in the clinical use of marketed products on quality documentation, NL proposed to
request the NcWP to develop a separate Q&A on the impact of such changes on non-clinical
Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)
documentation so that these aspects are also systematically considered. The CMDh agreed to submit this request to the NcWP.
In addition, a proposal for update of relevant CMDh variation guidance documents is under
preparation and will be tabled for the next CMDh meeting.
7. Reference to studies in hybrid dossier as per Q4 of Q&As on generic applications
The CMDh discussed the possibility for a hybrid application using a Reference Medicinal PRoduct (RefMP) to also refer to non-clinical and clinical studies of a dossier of an already approved hybrid application whereas no differences of the clinical particulars listed in Q&A 4 of the CMDh Q&As on generics (indication, strength, route of administration and pharmaceutical form) are present.
- The CMDh agreed that the application can be validated and it would be determined during the clinical assessment whether the studies are applicable/can be used for this product.
- The CMDh may rediscuss this topic following completion of the assessment and will consider whether this case should be reflected in the CMDh guidance, as needed.
8. Harmonisation of product information of generics
The CMDh discussed if all indications approved for a centrally authorised RefMP not covered
by (orphan) market exclusivity or usage patent, have to be included in the product
information of generics.
- The CMDh concluded that the applicant is expected to include all non-protected indications of the centrally authorised RefMP in a generic application and for existing MAs submits a variation to extend the indication upon expiry of any protection period.
- This would also be applicable in the case where some indications were omitted due to potential orphan similarity where non-similarity was later confirmed.
- It was noted that it remains the responsibility of the applicant to exclude from their proposed product information any protected/patented information valid in some or all Member States, while it is the responsibility of NCAs to assess if the proposed product information still guarantees the safe use of the product.
Reminder – New variation classification in eAF
The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
Users are reminded to verify the accuracy and content of the selected scopes (including the conditions and documentation), before submitting the form to the relevant health authorities. In case of any discrepancies, a ticket should be raised Request RMS Service – Employee Center
List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
You can view the list here.