Last updated: 30 April 2026
To view updates, click on the ‘+’ sign below.
Clinical Trial Information System (CTIS) – Sponsor Frequently Asked Questions (FAQ)
The CTIS Sponsor Frequently Asked Questions (FAQ) is based on questions frequently raised by sponsors during CTIS events such as walk-in clinics, bitesize talks, and through the EMA CTIS Service Desk It serves as complementary document to the Sponsor Handbook, which is the main operational guidance for sponsors when using CTIS.
Here, you can view the latest version of the FAQ dated 26 March 2026.
Source: EMA
CMDh Multi-annual Workplan to 2028
The CMDh multi-annual workplan (MAWP) to 2028 outlines the priorities of the CMDh and reflects the need for a coordinated approach to address the multiple challenges and opportunities that the network
faces.
The following four main priority areas have been included:
- Optimisation of procedures – Key priorities involve:
- streamlining slot booking procedures to improve the predictability of submissions
- improving validation practices ensuring adequate submissions by applicants and timely response from the Member States
- fostering stronger communication between Reference and Concerned Member States.
- Information technology and digitalisation
- The use of Artificial Intelligence as a tool with the potential to contribute to support regulatory decision-making and to increase efficiency.
- The CMDh will explore the potential of using direct data entries into SPOR databases as a model for data-driven regulatory processes and investigate the conditions and technical requirements that may be needed in this respect.
- In the context of EMRN-wide activities to foster AI, the CMDh aims to promote the usage of the existing AI solutions in the network, identify shared AI use cases, and potential providers to support these needs.
- Training
- The CMDh has established a clear goal to strengthen the EU regulatory network through comprehensive and up-to-date training programmes for regulatory assessment and procedural specialists.
- Implementation of the new pharmaceutical legislation
- The CMDh is prioritising preparedness for the implementation of the new pharmaceutical legislation and will take concrete actions to update/create procedures that reflect the upcoming regulatory changes.
- The CMDh will undertake a comprehensive mapping of all legislative changes relevant to MRP/DCP and compare them with existing practices, as well as identifying new regulatory aspects foreseen in the adopted version of the NPL.
- This gap analysis allows to identify where processes, guidance documents or systems need adaptation.
Source: HMA
CTIS walk in clinic – April 2026
This video covers the second CTIS (Clinical Trials Information System) walk-in clinic of the year held on 16 April 2026, featuring experts from the EMA and national regulatory agencies.
Source: EMA
Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
You can view Version 5 of the updated manual here.
Frequently asked questions related to Clinical trials submitted under the Regulation EU 536/2014
Here, you can view FAQ Version 2, April 2026. You can see the updates on page 3 of the document.
National requirements regarding clinical investigations falling under MDR articles 62, 74 and 82
You can view the updated table here.
Source: European Commission
Adoption survey for PLM Portal web-based electronic Application Form (eAF) users
As part of EMA’s commitment to continuous improvement, the eAF team has published an adoption survey to gather inputs and feedback on the PLM Portal web-based electronic Application Form (eAF.)
- You can access the survey by clicking this link:
- This survey aims to assess your level of satisfaction with PLM Portal web-based eAF use, as well as your experience with user support resources and communication.
- It also aims to identify potential concerns or challenges and provide valuable insights to help the eAF team implement necessary improvements or mitigation measures.
- You have until 24 April 2026 to complete the survey.
- It only takes a few minutes to complete the survey. Your responses will remain anonymous, and the results will not be publicly disclosed..
Source: eSubmission
Updated EMA guidance documents
The following EMA guidance documents have been updated:
- Procedural advice for orphan medicinal product designation – Guidance for sponsors, Rev 19 of 14 April 2026
- Procedural advice on paediatric applications – Guidance for applicants, Rev 15 of 15 April 2026
Links to recent EMA webinars
Mandatory Use of PLM Web-Based eAF for CAPs from 1 September 2026
The strongly recommended use of the PLM web-based electronic Application Form (eAF) for Centrally Authorised Products (CAPs) has been in place since July 2024.
- Over the past two years, submissions via the PLM eAF have steadily increased.
- To continue advancing the adoption of the PLM web-based eAF, the European Medicines Agency (EMA) will introduce mandatory use for CAPs as of 1 September 2026.
Why is this change being introduced?
The PLM web-based eAF enables faster and more accurate automated processing of application forms.
- It also supports integration with other EMA systems, contributing to a more efficient and streamlined submission and approval process.
- By contrast, the interactive PDF eAF may present technical issues that can lead to rejection of submissions. It is also slower to process and does not support the same level of system integration as the web-based solution.
How to prepare for mandatory use
Before 1 September 2026, users of the PLM portal eAF are advised to:
- Verify the integrity of their PMS data.
- Ensure all users in their organisation have the appropriate access rights and roles assigned in the PLM Portal: https://plm-portal.ema.europa.eu/Guidance/article/KA-01012/en-us
- Familiarise themselves with the PLM web-based eAF: https://plm-portal.ema.europa.eu/
- Consult the available material: https://plm-portal.ema.europa.eu/guidance-and-help/article/?artid=KA-01012
- Practice creating submissions in the PLM portal, even if they are not intended for submission. Draft forms can be created and later deactivated if not needed.
What will happen after 1 September 2026?
From 1 September 2026 onwards, any human CAP variation submissions sent to EMA using the interactive PDF eAF will be rejected unless it is accompanied by a valid and justified technical reason preventing the use of the PLM web-based eAF.
Possible technical reasons preventing the use of PLM eAF
The following known technical limitations may justify the use of the interactive PDF eAF:
- Performance issues for large applications: The PLM portal currently has performance limitations when handling large applications of over approximately 200 medicinal products. Improvements for large applications are planned for 2026.
- Medical Devices section: a known issue in this section requires the continued use of the interactive PDF eAF.
- PMS data issues: A full list of known PMS issues is available in the PMS FAQ document (page 16), including expected resolution timelines. Examples include: duplicated products or packages, duplicated entries, truncated product names. Applicants should review this list and follow recommended actions before submitting a support ticket.
- OMS data issues: Issues in the intermediate data layer (dataverse) may impact organisational data used in the eAF. A platform-level review is ongoing. Existing and future workarounds aim to address synchronisation issues, including those related to contact persons and proof of payment.
- Lack of access to the PLM portal: Some organisations have not yet enabled co-authoring or provided access to all required users (e.g. in worksharing scenarios). In such cases, the interactive PDF eAF remains the only viable option.
- Other (unknown) technical issues: Unlisted technical issues may also be accepted, provided they are flagged on time and impede the correct finalisation of a PLM portal form. If users encounter issues close to a submission deadline that block the completion of the PLM web-based eAF, they may use the interactive PDF eAF.
Further details on how to justify the exceptional use of the PDF eAF will be communicated prior to the beginning of the Mandatory use for CAPs.
Additional guidance
- Users should raise a service desk ticket for issues that may be resolvable (e.g. PMS, OMS, or newly identified issues): https://support.ema.europa.eu/esc
- Requests will be handled based on priority and order of receipt, with feedback provided on resolution timelines.
- If the estimated resolution time conflicts with a submission deadline, applicants should use the interactive PDF eAF.
- If service desk response times are longer than expected, the interactive PDF eAF may be used.
For known limitations such as large applications, Medical Devices issues, or lack of PLM portal access, users are not required to raise a service desk ticket.
Please follow the PLM portal and eSubmission for updates on the mandatory use of the PLM portal eAF for CAPs and on how to report any impediments.
Source: eSubmission
Data Quality Framework for EU medicines regulation: application to Real-World Data
Here, you can view the final versions of the document with the above title.
Key takeaways form the document:
- Refined criteria: Clearer metrics for assessing reliability and extensiveness.
- Operational guidance: Direct advice on characterising the processes underpinning your data.
- Decision-ready evidence: Ensuring RWD can stand up to the highest levels of regulatory scrutiny.
Report and minutes from the CMDh meeting held on 24-25 March 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. CMDh guidance documents related to variations (Report pg 2, minutes pgs 9,10 and 11)
The CMDh agreed to update the following:
- CMDh Q&A on Variations – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- the Position paper common grounds seen for invalidation/delaying day 0 for variations – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- Examples for acceptable and not acceptable groupings for MRP/DCP products – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- the Preliminary Variation Assessment Report Template – Here, you can view the track changed (Feb 2025) and clean (Mar 2026) versions of the document.
These guidance documents have been revised to reflect the principles of the recently published 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 a product on quality documentation.
- During its February meeting, the CMDh agreed on the possibility of accepting the grouping of Type IA and Type IAIN variations outside the annual update of Type IA variations, provided that the changes are very clear and obviously related.
- In line with this agreement, the CMDh has now updated:
- the CMDh BPG for the Processing of (Super-)Grouped Applications in MRP (Chapter 6) – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- the Examples for acceptable and not acceptable groupings for MRP/DCP products – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- In addition, the CMDh agreed to update the CMDh BPG for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1), to clarify the allocation of procedure numbers for annual update of Type IA variations. Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document
- The updated guidance documents have now been published on the CMDh website under “Procedural Guidance> Variation”. Links are also provided above.
2. CMDh guidance documents related to Paediatric Worksharing procedures (Report pg 2, minutes pg 10)
The CMDh agreed an update of the following in order to bring them in line with the
new EC guidelines on the details of the various categories of variations and operation of the
procedures:
- The Best Practice Guide for Article 45 and 46 paediatric worksharing procedure – Here, you can view the track changed (Mar 2026) and clean (Mar 2026) versions of the document.
- Questions and Answers on the Paediatric Regulation – Here, you can view the track changed (Feb 2025) and clean (Mar 2026) versions of the document.
In addition, the BPG has been updated to clarify that, when submitting a variation toupdate the product information, the variation cover letter should clearly state that the proposedchanges are based on the results of the paediatric Article 46 study.
- In such cases, no parallel paediatric worksharing procedure will be started.
- The updated guidance documents have now been be published on the CMDh website under “Paediatric Regulation > Guidance Documents”. Links are also provided above.
3. Guidance for preparation of Public Assessment Reports (Report pg 3)
The CMDh agreed on an update of its guidance for preparation of Public Assessment Reports:
- D70 Overview AR template (empty) – Here, you can view the track changed (Nov 2025) and clean (Mar 2026) versions of the document.
- D70 Overview AR template (incl. instructions) – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- Instructions for RMS when preparing the PAR based on the FAR (Mar 2026)
- PAR template (empty) (Mar 2026).
- The documents have been updated to include reference to the requirement for applicants to comply with the applicable EU legislation on clinical trials of medicinal products for human use, as relevant to their specific application.
- The guidance and template documents have now been published on the CMDh website under “Templates >Assessment Reports > Public AR”. Links are also provided above.
4. CMDh position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal product (Report pg 3, minutes pg 11)
The CMDh agreed an update of the position paper on the use of mobile scanning and other
technologies to be included in the labelling and/or package leaflet, along with its annexes (see links below), in order to clarify the conditions under which applicants/MAHs may include links to statutory information hosted on platforms created and operated by third parties.
- The documents have been revised to provide updated information on all aspects of the inclusion of mobile technologies for products applied for/authorised via MRP/DCP.
- The EMA QRD Working Group and the EC have been consulted on certain aspects of the update to ensure an aligned approach with products authorised via the centralised procedure, as much as possible.
- The updated documents have now published on the CMDh website under “Procedural Guidance > General Information”. Links have also been provided below.
Here, you can view the track changed and clean versions of the following:
- Position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet, track changed (Oct 2023) and clean (Mar 2026) versions.
- Annex 2 – Applicant’s declaration template (Mar 2026)
5. New applications in the MRP and DCP started in February 2026 (tabulated on pages 5 and 6 of the report)
At this link you can view the stats as bar charts.
6. New Pharmaceutical Legislation (NPL)
The EC provided a brief oral update on the NPL timeline, its application and planned
implementation (including the need to prepare implementing and delegated acts).
- The CMDh stressed the need for consistent interpretation within the network, close involvement in all relevant workstreams, and alignment through the mapping of provisions to avoid overlap and ensure timely handling of these topics.
- Member States were reminded to submit any questions or expectations in advance to the EC, in preparation for the next CMDh plenary meeting.
7. Multiple use of legal base Art. 10b Directive 2001/83/EC
The CMDh was informed about the submission of pre-judicial questions to the Court of Justice
of the European Union (CJEU) about the possibility for multiple use of legal basis Article 10b
of Directive 2001/83/EC for the same combination of active substances.
- The questions follow a previous judgement of a national court in The Netherlands which excluded multiple applicants from obtaining a marketing authorisation for the same combination through this legal basis.
- It was noted that many MSs accept the multiple use of Art. 10b for the same fixed dose combination and the EC has expressed their agreement with this approach in the past.
- The judgement has been appealed by NL and a MAH and the necessity for asking pre-judicial questions to the CJEU to ensure consistent interpretation of EU law across all Member States was confirmed.
- MSs were informed that written observations can be submitted to the court until 21 April 2026.
- It was further noted that the wording of the legal basis has been updated in the proposal for the New Pharmaceutical Legislation.
- France and Spain informed the CMDh that they had national rulings in the past allowing the use of Article 10b for the same combination of active substances by multiple applicants.
- France and Spain were asked to share their court outcome with the CMDh.
- It was proposed that the case could also be brought to the attention of EMACOLEX.
- The judgement of the CJEU will be brought back to the attention of the CMDh once available.
8. Medical Device Regulation
Following the discussions in the CMDh in May/June 2024, The Netherlands informed the CMDh of the outcome of the discussions in the MDCG Borderline & Classification Working Group on the classification of micro-enemas with a long nozzle as medical device or as container closure system.
- The WG concluded that the package would fall under the definition of a medical device.
- The package for a medicinal product, used as laxative, is made to be used for rectal insertion and administration of the medicine.
- The package is a single dose mini-tube, with a long nozzle.
- In this case, the packaging for a medicinal product, used as laxative, is designed for rectal insertion and administration of the medicinal product into the body, thereby falling under the definition of a medical device.
- Thus, it cannot be considered to being purely a “simple” packaging solution.
- Because the product forms a single integral medicinal product, which is intended exclusively for use in the given combination and which is not reusable, the medical device part (the packaging) must comply with the requirements of the MDR in accordance with article 117 MDR.
- Proof of conformity with annex I MDR must be provided in the marketing authorisation dossier of the integral medicinal product.
- Article 117 is implemented in the Annex I to Directive 2001/83/EC, point 12 of section 3.2.
- The outcome will be published in the Manual on Borderline & Classification for Medical Devices.
9. Acceptability of an UK reference medicinal product
The CMDh discussed the acceptability of an UK reference medicinal product (RefMP) and the
concept of same applicant/MAH in a generic application.
- The application was submitted in 2022 and used a UK RefMP for the BE studies.
- The BE studies were finalised in 2009 and 2015 and would therefore be acceptable for submissions in the EU.
- However, the applicant did not provide yet evidence that the MAH(s) of the RefMP used for data protection and the MAH of the UK RefMP used for the BE studies can be considered the same (i.e. the RefMP(s) belong to the same GMA).
- As in the meantime there have been changes of the MAHs, the CMDh confirmed a previous agreement that the relevant time for the evaluation of the same global marketing authorisation is the submission date of the generic application.
- It was noted that generally it’s the applicant’s responsibility to provide information that the RefMP(s) belong to the same GMA.
- The CMDh agreed that both RefMPs can be considered as belonging to the same GMA and can both be included in the AF.
- The applicant will be asked to update the AF accordingly.
CTIS technical issues: no fee for resubmission of clinical trial applications
As of 1 January 2026, sponsors will not be charged a fee for the Clinical Trial Regulation safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System, provided that these issues occurred after validation.
- In exceptional cases, technical issues in the the Clinical Trials Information System (CTIS) require the resubmission of a clinical trial application, even after validation.
- As of 1 January 2026, sponsors will not be charged a fee for the CTR safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System.
- This fee exemption applies only if the content of the resubmission package is identical to the validated submission package of the original application.
Follow the instructions at the link below to request a fee exemption .
Source: FAHMP