The CTCG is an HMA working group of experts in the classification, assessment and oversight of clinical trials from National Agencies.
The objective of CTCG is to contribute to increasing the attractiveness of the EU/EEA for clinical trials by harmonisation and optimisation of the regulatory environment while assuring the protection of rights, safety and wellbeing of the subjects and the generation of robust data.
Early clinical trials are the first contact of regulators with innovation. CTCG will monitor these trends and evolutions in clinical trials and will develop and publish guidance documents.
CTCG Mandate | pdf
- Representatives from the national competent authorities for the authorisation and surveillance of clinical trials on human subjects, the European Commission and the European Medicines Agency
- Representatives from other interested parties may be invited to attend the CTCG meetings on an ad hoc basis if deemed valuable and consensual and in agreement with the HMA rules on observers
- The chair and vice chair are elected amongst the members for a period of three years
- Currently chaired by two chairs: Marianne Lunzer, PhD (AGES MEA, Austria) and vice-chair: Greet Musch, PhD (FAMHP, Belgium)
- The mentor of the group at the level of HMA is Björn Eriksson, MD, PhD (Läkemedelsverket, Sweden)
The secretariat of the group is managed by Italy. The HMA contact is Giovanni Affronti from the Italian Medicines Agency (AIFA).
Contact: ctfg.secretariat@ aifa.gov .it
Election of chair and vice chair on 15 February 2022
Workplan | pdf
CTCG Workplan | pdf
- Since March 2022, the Clinical Trials Coordination Group (CTCG) is responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project.
The EU DCT project is part of the priority actions conducted in the context of the Accelerating Clinical Trials in the EU (ACT EU), which started at the same time as the launch of the Clinical Trials Information System (CTIS) and the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR).
The DCT project represents a broad collaboration across the European Medicines Regulatory Network with a cross-disciplinary project group including amongst others clinical trial authorisation experts, ethical experts and Good Clinical Practice (GCP) inspectors across Member States.
It aims to provide a harmonised and transparent approach for the use of DCT elements in clinical trials. To this end, a Recommendation paper on the use of DCT elements in clinical trials is planned to be published by the end of 2022.
Continuing the work of CTFG all the CTFG guidance documents are still applicable until updated under CTCG responsibility:
UK/EU transition period will end on December 31 2020.
CTFG Activity Report
Clinical Trials Authorisations (CTAs)
- Results of the Voluntary Harmonisation Procedure 2009 - 2021, February 2022 | pdf
- Conclusion of the Voluntary Harmonization Procedure project, July 2021 | pdf
- VHP - Brexit and Christmas Break, October 2020 | pdf
- Results of the Voluntary Harmonisation Procedure 2009 - 2020, February 2021 | pdf
- VHP procedures in preparation and in case of a no-deal Brexit | pdf
- European Union Member States national pilot projects in support of the transition to the new Clinical Trial Regulation EU 536/2014, October 2020 | pdf
- European Union Member States participation in VHP and VHP-related activities, October 2020 | pdf
- Guidance document for sponsors for a Voluntary Harmonised Procedure for the assessment of multinational Clinical Trial Applications, Version 5, October 2020 | pdf
- Best Practice Guide for Sponsors of document naming in CTIS | pdf
In order to simplify the re-submission process to CTIS CTCG accepts that the CT numbers within the documents uploaded into the system are shortened concerning the last 2 digits which only show how often the sponsor created previous submissions and re-submitted the applications.
In case of a decision letter the full number including the last 2 digits will be reflected.
If the full number is reflected in the documents and a re-submission takes place, there is no expectation that these numbers are immediately corrected within the documents during the ongoing procedure. This can be done at a later stage when the documentation is updated during a SM procedure.
- Complex clinical trials (CCTs) – Questions and answers
The European Commission, EMA and CTCG have jointly issued new "Complex Clinical Trials - Questions and Answers" document for which “Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials” issued in 2019 by the former CTFG has served as a basis. This document provides clarification or additional information and lays out certain considerations regarding scientific aspects, planning and set - up, submission for obtaining CT authorization (CTA), conduct, reporting and transparency, analysis and interpretation of Complex Clinical Trials (CCTs) under the EU Clinical Trials Regulation 536/2014 (CTR) and EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), as well as their use in submissions for marketing authorization.
The document can be accessed here
- CTR/IVDR (In Vitro Diagnostic Medical) – Questions and answers
Available here and here
- Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic | pdf
Update of the guidance 28 April 2020 available here
- Link to National guidance on CT management during the COVID-19 pandemia | pdf
Updated on 31 March 2020
- Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials | pdf
- Best Practice Guide for sponsors of transition multinational clinical trials | pdf
- Q and As on GLP, March 2017 | pdf
- Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1 | pdf
Update to document has been adopted and implemented on 21/09/2020
The changes are as follows:
- after the relevant systemic exposure to the medicinal product has ended for exposure to other types of genotoxicants than aneugenic compounds, the duration for applying highly effective contraception measures for women of childbearing potential, has been extended from 1 month to 6 months (one folliculogenesis cycle).
- the need for informing participants to seek advice about donation and cryopreservation of germ cells in line with this guidance prior treatment if applicable, has been added to the section on the need for sexual counseling of study subjects, e.g. in adolescents, which should be reflected in the protocol.
- Overview of the fees charged by NCAs for submission of different types of clinical trial or amendments, January 2012| pdf
- Q and As - Frequently asked questions on CTs, updated January 2012| pdf
Clinical Trials Safety
- DSUR Q and As, 2012| pdf
- Q&A document – Reference Safety Information, November 2017| pdf
- Covering Note - Q&A Reference Safety Information, March 2018 | pdf
CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials | pdf
Updated July 2022
Meeting schedule for 2022
|03-04/05/2022||EMA (virtual)||10:00 - 17:00|
|21-22/06/2022||EMA (virtual)||10:00 - 17:00|
|06-07/09/2022||EMA (virtual)||10:00 - 17:00|
|24-25/10/2022||CZ Presidency (Brussels)||10:00 - 17:00|
|06-07/12/2022||TBD||10:00 - 17:00|
SAFE CT - Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials
The new Clinical Trial Regulation EU No. 536/2014 and Implementing regulation (IR) which came into force on 31 Jan 2022 introduced the concept of safety cooperation and work-sharing among Member States (MSs)
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials or SAFE CT supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating MSs. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.
The project is currently in grant agreement preparation phase and will run for 36 months (with a retrospective start date from 01/05/2022 – 01/04/2025).