Last updated: 20 March 2026
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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 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 from the above meeting includes (but js 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.
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.