CMDh and other EU updates – June 2024

Last updated: 13 June 2024

Accelerating Clinical Trials in the EU (ACT EU) initiative launches two advice pilots aimed at improving the quality of applications for clinical trials

ACT EU:

  • is a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in the Member States and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run.
  • was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU features priority action areas that are the basis for the ACT EU multi-annual workplan 2023-2026.

ACT EU has launched the following two advice pilots:

Pilot 1

The first pilot offers developers of medicinal products scientific advice on clinical trials and on requirements for marketing authorisation applications (MAA).

  • Assessors of clinical trials are not consistently involved in scientific advice procedures for MAAs, and vice versa.
  • In this pilot programme, the Scientific Advice Working Party (SAWP), coordinated by EMA, and the Clinical Trials Coordination Group (CTCG), managed by HMA, will be the bodies assessing incoming requests of a scientific nature.
  • The SAWP is responsible for advice on marketing authorisation applications and the Member States represented at CTCG oversee clinical trial applications (CTA). 
  • This pilot consolidates the views of these two groups to minimise avoidable divergences.
  •  It is the first time that both entities are providing joint scientific advice on clinical trials.

Pilot 2

The second pilot is coordinated by the CTCG and provides technical and regulatory support on the dossier of a CTA prior to its submission through the Clinical Trials Information System.

  • Before this pilot, applicants could only receive technical and regulatory support at national level from the Member State evaluating the application.
  • The pre-CTA pilot will provide consolidated views of the Member States concerned on pre-submission topics.
  • The scope of this pilot covers a number of areas such as advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs, to name a few.

Starting 10 June 2024, developers of medicinal products who wish to receive advice on the requirements for a MAA or a CTA may apply to these pilots.

  • The duration of both pilots will be evaluated over time based on data and feedback collected from applicants.
  • All this information will inform a possible change of scope and a final decision from the ACT EU steering group on how to optimise clinical trial support in the future.

Guidance for applicants: pre-CTA advice pilot is available here. Further information and other documents are available at the link below.

Source: EMA


Report from the CMDh meeting held on 28-29 May 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 from the above meeting includes (but is not restricted to) the following items:

1. Regulation (EC) No 1234/2008 on variations

The CMDh agreed an update of its Questions and Answers on Variations.

  • A new Q&A (3.32) has been added to provide guidance on how a change should be submitted to update section 5.1 of the SmPC to include EUCAST breakpoints in line with the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95).
  • The updated document will be published on the CMDh website under “Questions & Answers”.

A link to the document will be provided here once available.

2. Data requested for New Applications in the MRP/DCP

The CMDh agreed an update of the document “Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers”.

  • The document has been reorganised and the information for some Member States has been updated where needed.
  • The updated document has been published on the CMDh website under “Procedural Guidance > Application for MA”.
  • Here, you can view the track changed (April 2021) and clean (May 2024)versions of the document. This document has been updated substantially.

3. Mock-ups, specimens and samples for variations

The CMDh agreed an update of the document “Mock-ups, specimens and samples for variations”.

  • The procedural guidance document has been revised in accordance with current Member States’ practices, where necessary.
  • The updated document has been published on the CMDh website under “Procedural Guidance > Variation”. Here, you can view the track changed and clean versions of the document.

4. Active Substance Master File worksharing

In January 2024, the CMDh agreed an update of the document “The worksharing procedure for the assessment of Active Substance Master File (ASMF)” prepared by the Working Group on ASMF procedures.

  • The document has been revised based on the experience gained since the implementation of the procedure.
  • The main change is to allow already approved ASMFs (with an assessment history of at least 2 years) to step into the ASMF worksharing procedure under certain conditions.
  • The EU ASMF number request form will be updated accordingly.
  • The procedural guidance document has now been adopted by all relevant groups and has been published on the CMDh website under “CMD Working Parties/Working Groups > WG on ASMF procedures”. Here, you can view the track changed and clean (May 2024) versions of the document. This is a substantial update.

5. Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)

The CMDh in liaison with the EMA and the European Commission has agreed an update of the joint EMA/CMDh Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746).

  • The main objectives of this update are to reflect the experience gained from the MDR implementation (particularly Article 117) and IVDR implementation.
  • The updated Q&A document has been published on the EMA website and linked from the CMDh website under “Questions and Answers”.

Here, you can view the track changed and clean versions (Rev.4 May 2024) of the document. You can read more about this topic in this blog post.


Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers

The document with the above title has been updated substantially. Here, you can view the track changed and clean versions.

Source: HMA


The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF) 

The document with the above title has been updated quite substantially. Here, you can view the track changed and clean versions.

Source: HMA


Procedural advice on paediatric applications

This guidance has been updated to Rev. 9.0 4 June 2024. You can view it here.

Source: EMA


User guide for micro, small and medium-sized enterprises

This user guide was updated in March 2024, specifically Section 4.4. Clinical trial applications and their management – reflecting changes in Clinical Trials Regulation. The update was made available recently. You can view it here.

Source: EMA


Simultaneous National Scientific Advice (SNSA)

For the above, the list of participating NCAs and contact information was updated in June 2024. You can view the updated list here.

Source: HMA

Updates
DateUpdate(s)
13 Jun 20241) Links provided under the section Accelerating Clinical Trials in the EU (ACT EU) initiative launches two advice pilots aimed at improving the quality of applications for clinical trials.
2) Link added to document mentioned under the section Report from the CMDh meeting held on 28-29 May 2024, sub section 2. Data requested for New Applications in the MRP/DCP.
11 Jun 2024New section Accelerating Clinical Trials in the EU (ACT EU) initiative launches two advice pilots aimed at improving the quality of applications for clinical trials added.
6 Jun 2024The following new sections were added:
1) Report from the CMDh meeting held on 28-29 May 2024
2) Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers
3) The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF)