Last updated: 22 November 2024
SME Info day
Here is a link to the EMA webinar SME Info Day held on on 18 October 2024.
Time stamps for the various sessions in the webinar are provided below.
00:00:00 Session 1: Scientific Advice
00:42:07 Session 2: Clinical Trials
01:15:52 Session 3: Health Technology Assessment (HTA)
01:52:44 Session 4: Medical devices
02:44:55 Session 5: The New EMA Fee Regulation
03:10:22 Session 6: Management of Shortages
A transcript of the webinar is also provided at the link.
The webinar presentations are provided at this link.
Report and minutes from the CMDh meeting held on 15-16 October 2024
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. Update of CMDh guidance documents related to variations
The CMDh agreed updates of several guidance documents and templates related to variations to bring them in line with the amended Variation Regulation.
The updated documents and further details have now been published on the CMDh website by the end of October under “Procedural Guidance > Variations > Guidance on the Application of the Amended Variations Regulation from 1 January 2025.
You can also read more about the updated documents in this blog post, starting from the heading Guidance applicable from 1 January 2025- MRP variations.
2. Recommendations on submission dates for applicants of the DCP and MRP
The CMDh has adopted updated guidance documents with the timetables for MRP/DCP applications to be submitted in 2025.
The updated guidance documents have now be published on the CMDh website under “Procedural guidance > Application for MA > MRP/DCP”. YOu can view them at the links below:
- Recommendations on the submission dates in 2025 for Applications of the MRP – document (Oct 2024 Rev. 18)
- Recommendations on the submission dates in 2025 for Applications of the DCP – document (Oct 2024 Rev. 19)
3. MAHs to prepare for PMS edit function in support of shortage monitoring (+ upcoming webinars)
From Q1 2025, EMA will launch write access for Marketing Authorisation Holders (MAHs) through the Product Management Service (PMS) Product User Interface (PUI) first and Application Programming Interface (API) later.
- This functionality will be crucial for shortages monitoring via the European Shortages Monitoring Platform (ESMP).
- MAHs should start preparing.
- Write access will enable the enrichment of the followinfdata concerning structured pack size, data carrier identifier(s) and manufacturer in PMS, information required by ESMP.
- Standardised product information availability in PMS will simplify reporting requirements for both MAHs and National Competent Authorities (NCAs) to the ESMP.
- Detailed guidance is provided on pages 2 and 3 of the report on what should MAHs do now to prepare.
- Information is also provided on page 3 of the report on the following:
- Upcoming informative webinars
- Upcoming Q&A Clinics on PUI and API
4. Preparatory activities for MAHs (MRP/DCP/NAP) for January 2025 post-authorisation procedures transition to IRIS (+ upcoming training)
Transition of post-authorisation procedure management to the IRIS platform from January 2025, means that the majority of EMA-led procedures will be managed through IRIS.
- Marketing Authorisation Holders need to take action to effectively prepare for this change.
- The following EMA-led procedures will transition to IRIS for all involved non-centrally approved products, non-CAPs (includes MRP/DCP/NAP) from January 2025:
- PSUR
- Referral
- PASS
- Important: Submissions for all regulatory procedures of the product lifecycle will continue to be performed via the current systems (i.e. Gateway and PSUR repository)
- In scope: Marketing Authorisation Holders (MAHs) for non-CAPs. To ensure proper access to the IRIS platform, the EMA requires that:
- all contacts are registered in the EMA Account Management System (IAM) by 30 November 2024:
- Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs.
- Ensure that access is requested for the relevant organisations affiliated with the products you are the contact for (Request Access · EMA Account Management (europa.eu)).
- Upcoming training session: The EMA is organising a training session on 12 November 2024 (10:00 – 11:30 (CET)) to provide you with key instructions to be prepared for the transition, showcase the IRIS system and answer your questions. Register here.
5. Non-CAPs data available now in the PLM Portal web based eAF (+training)
The non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.
- Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities.
- However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations containing CAPs and non-CAPs.
- Please see an updated version of the draft PLM Portal eAF guide to navigation is now available.
In order to familiarise with the new functionality of web-based eAFs for Human non-CAP variation procedures, the eAF team provided a dedicated training session on 17 October 2024. Here is a link to the webinar.
Additionally, the eAF team provided:
- a Q&A clinic on web-based eAFs for Human non-CAP variation procedures was held on on 25 October 2024. Here is a link to the webinar.
- a Training and Q&A Clinic for Human Variation eAF new fixes/functionalities was held on 8 November 2024. You can view the presentation from the meeting here.
- A Q&A Clinic on eAF variations was held on 14 November 2024. You can view the webinar here.
- Key actions for Marketing Authorisation Holders:
- Register as an eAF user in the PLM Portal following the registration process and log into the eAF for familiarisation and testing purposes;
- Follow EMA announcements to be informed of the date when web-based eAF can be submitted to the NCAs. This is currently expected to start in January 2025;
- Continue to submit the interactive PDF eAFs to the NCAs for non-EMA led procedures;
- Gather user feedback related to non-CAP variations within your organisations (MAHs and industry organisations) and to provide this consolidated feedback to EMA via plm.valuestream@ema.europa.eu.
6. Variation application form
The CMDh discussed and agreed a proposal to update the Variation Application Form to align
it with the amended Variation Regulation provision that introduces mandatory worksharing
procedure for type IB and type II variations.
- Comments from MSs were taken into account, as appropriate.
- The proposal will be forwarded to the eAF Regulatory Focus Group for further discussion and implementation.
7. Medicine shortage communications (MSCs) – template
The EMA presented a new template and process for Medicine Shortage Communication
(MSC).
- The principle of the process is that communications that concern critical supply or shortages, without an associated Q/S/E issue, will be endorsed by MSSG (with the new MSC template).
- CHMP/CMDh will be kept informed of the process.
- A 6-month pilot for the use of the new template and process has been started.
8. Guideline on quality and equivalence of locally applied, locally acting cutaneous products
The CMDh noted the publication of the updated guideline on quality and equivalence of locally applied, locally acting cutaneous products. The guideline will come into effect on 2 April 2025.
EU eCTD v4.0 draft Implementation package now available
An updated draft version of the EU eCTD v4.0 implementation package is now available here.
The package contains the following:
- EU eCTD v4.0 Implementation Guide draft version 1.2 ; this version is focused on CAPs and the main changes since version 1.1 are reflected in the “Document change history” of the file
- EU eCTD v4.0 Controlled Vocabularies, in .xlsx format (version 1); the genericode files (.xml format) will be published in the following weeks
- EU eCTD v4.0 Accepted file formats
An upcoming updated package (containing the genericode files for the controlled vocabularies and the validation criteria) will be made available in the coming period.
- The package is meant for eCTD tool vendors to access the new format of the Controlled Vocabularies and the new OIDs, as well as to be notified by the changes in the EU eCTD v4.0 Implementation Guide (version 1.2).
- According to the EU eCTD v4.0 implementation timeline, a technical pilot for eCTD v4.0 in EU (focused on CAPs) is planned to start by the end of 2024, and more details will be published on the eSubmission website.
- If you are an eCTD tool vendor, have already developed eCTD v4.0 capabilities in the tool and are interested in participating in the EU eCTD v4.0 pilot, follow the eSubmission website for the upcoming announcement, or send your intention to join the pilot at ectd4consultation@ema.europa.eu.
Source: eSubmission
Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh
Revision 3 of October 2024 has now been published. You can view it here.
Source: HMA
EMA Management Board: highlights of October 2024 meeting
Among the presented highlights at the board meeting were the following:
Handling declarations of interests of scientific committee members and experts
The Board endorsed a draft revision to EMA’s policy on handling of competing interests of scientific committees’ members and experts (Policy 0044) for public consultation.
- EMA’s independence policies have provided a robust and balanced framework for managing possible competing interests over many years.
- The revision aims to reflect changes to this framework following recent court judgements (i.e. the appellate judgments of the Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P).
- A news announcement with additional information will be published at the start of the public consultation in the coming days, together with the draft revised policy.
- The final revised policy is intended to be presented to the Board for adoption in December 2024.
Clinical trials in the EU
EMA updated the Board on upcoming milestones for clinical trials in the EU.
- By 30 January 2025, all ongoing trials approved under the previous Clinical Trials Directive must be transferred to the Clinical Trials Information System (CTIS) to adhere to the Clinical Trials Regulation.
- Around 3,000 clinical trials have already been transitioned to CTIS. Sponsors are strongly advised to submit the remaining applications as soon as possible considering the time necessary to complete the authorisation process, which can take up to three months.
- With the implementation of the revised transparency rules, information and documents on over 6,100 trials are now available on CTIS.
- New features introduced in September allow users to search for specific trials more easily.
- Additionally, changes have been made to the interface to improve the overall user experience.
- The Accelerating Clinical Trials in the EU (ACT EU) initiative is holding the annual meeting of its multi-stakeholder platform on 22 October 2024.
- The event will be broadcast and is open to all relevant stakeholders.
Source: EMA
Information session on the pilot for expert panels’ advice for orphan medical devices
EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices with the challenges linked to generating clinical evidence for these devices in the premarket phase (see Medical devices).
- The expert panels can offer advice on the orphan device’s status, the intended clinical development strategies, proposed clinical investigations, or on the data required for the clinical evaluation during an ongoing conformity assessment.
- This programme is being launched as a pilot to help implement the processes outlined in the MDCG 2024-10 document on clinical evaluation of orphan medical devices.
- Starting from 2 August 2024, EMA has begun accepting letters of interest from manufacturers and notified bodies that would like to be considered for this pilot.
- EMA, in collaboration with representatives from the European Commission, the Medical Device Coordination Group (MDCG) and the expert panels, had a joint information session that covered the following topics:
- Introduction of the new definition and criteria for the orphan status for medical devices in the EU
- Strategies for manufacturers to overcome the challenges in generating clinical evidence for orphan devices considering the limitations in pre-market clinical data and how the post-market phase can be utilised to mitigate such limitations;
- Overview of the new pilot programme and how to apply for scientific support from the expert panels
- Demo of the submission portal.
- You can view the agenda of the information session here and the webinar here
Source: EMA
Harmonisation of SmPC – Article 30 (1) (of Directive 2001/83/EC as amended) Referrals
Here, you can find the updated (October 2024) tracking table.
Source: HMA
Improving efficiency of the approval process for new medicines in the EU
EMA and the European medicines regulatory network (EMRN) are working to further improve efficiency in the assessment and approval processes for new medicines in the EU. The initiative aims to:
- better manage the use of the network’s expert resources
- streamline assessment processes
- encourage more comprehensive application dossiers from marketing authorisation applicants at the time of initial submission.
One of the areas identified as needing improvement is the reliability of long-term planning for initial marketing authorisation applications (MAAs). This has been a recurrent problem for the network for many years, binding precious assessment resources and slowing down medicine approval times.
A multi-stakeholder workshop took place on Wednesday, 25 September 2024 to discuss submission predictability and how it can be improved.
- A report with further recommendations to industry is under preparation and presentations from the workshop will be published.
- Other ongoing measures that aim to ensure the sustainability of the EU regulatory network are:
- Reinforcing best practices for requests for clock-stop extensions
- In April 2024, EMA’s human medicines committee (CHMP) and the Committee for Advanced Therapies (CAT), introduced a standard template for the request of clock-stop extensions.
- From July 2024, both committees have started to apply the provisions of the 2009 guideline more strictly.
- All requests for clock-stop extensions need to be well justified and the CHMP and the CAT will no longer grant extended clock-stops to solve problems caused by immature application dossiers or issues that were foreseeable prior to the submission of the application.
- Streamlined templates
- In 2023, EMA revamped its two main assessment report templates: the ‘Day 80 non-clinical assessment report’ and the ‘Day 80 clinical assessment report’ Assessment templates and guidance.
- Work is ongoing on the quality assessment report as well as a dedicated ‘Day 80 clinical assessment report’ for biosimilars.
- In addition, the launch of a revamped ‘Overview template’, which evolves from Day 80 of the procedure until the final European Public Assessment Report (EPAR), is planned for January 2025.
- With the new templates, there is a clearer differentiation between the evidence submitted by the applicant and EMA’s assessment. Information has been better structured, and duplication deleted.
- Better guidance for assessors
- A number of initiatives are ongoing, looking to provide better guidance to assessors in the national competent authorities, whether through the assessment report templates, guidance and/or checklists and training, with the overall aim of building efficiency and consistency in the assessment process.
- Better predictability of post-marketing activities
- In May 2023, EMA piloted an automatic email notification to all marketing authorisation holders, requesting them to submit a list of their planned line extension and major variation submissions for the following six-month period.
- This automatic request will be sent to each company contact point on 1 May and 1 November going forward.
- This will allow rapporteurs to have better visibility of the volume of post-approval work that they can expect in relation to a product.
- Closer dialogue with applicants
- In 2025, EMA plans to launch a project dedicated to improving pre-submission interactions with applicants.
- A joint project with NCAs and industry associations will aim to find practical solutions to address the increasing number of dossiers submitted with premature data and to improve submission predictability through closer communication between the applicant, EMA and rapporteur teams well in advance of the planned MAA submission date.
- Reinforcing best practices for requests for clock-stop extensions
Source: EMA