CTCG Introduction/Overview/Mandate

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

 

CTCG Members and Alternates

  • CTCG Members and Alternates are nominated by each EU/EEA National Competent Authorities (NCA) and represent the NCA.
  • The Chair and the Vice-Chair of the CTCG are elected amongst the members for a period of three years. Currently CTCG is chaired by Marianne Lunzer, PhD (AGES MEA, Austria) and vice-chaired by Monique Al, PhD (CCMO, Netherlands)
  • The secretariat is supported by the EMA and an expert from an NCA. The secretariat acts as the contact point for the group.
  • The EMA and the Commission attend the meetings as observers.
  • Representatives from other interested parties and national experts may be consulted and invited to attend the CTCG meetings on an ad hoc basis.

List of CTCG Members and Alternates

 

Member StateRoleMember Name
AT - AustriaChair/MemberMarianne Lunzer
AT - AustriaAlternateJudith Secklehner
BE - BelgiumMember Anne Lenaers 
BE - BelgiumAlternate Nele Steens
BG - BulgariaMember Ivelina Gushlekova
BG - BulgariaAlternate Ivan Todorov
CY - CyprusMemberEleni Georgiadou
CY - CyprusAlternateTheognosia Patsaledou
CZ - Czech RepublicMember Eva Hrušková Reinová 
CZ - Czech RepublicAlternateJan Nemecek
DE - Germany (BfArM)MemberClaudia Riedel 
DE - Germany (BfArM)AlternateSarah Heil 
DE - Germany (PEI)MemberSusanne Lerch
DE - Germany (PEI)AlternateAndreas Bonertz
DK - DenmarkMemberLene Grejs Petersen
DK - DenmarkAlternatePernille Sterling
EE - EstoniaMemberKeiu Heinla
EE - EstoniaAlternateIngrid Kiisk
ES - SpainMemberJuan Estévez Álamo 
ES - SpainAlternateLaura Lavin de Juan
FI - FinlandMemberMarita Kailajärvi 
FI - FinlandAlternatePirjo Inki
FR - FranceMemberCorinne Kiger
GR - GreeceMemberLeonidas Klironomos
HR - Croatia (HALMED)MemberMaja Puklek
HR - Croatia (HALMED)Alternate Ivana Kosier Mihalic
HR - Croatia (Miz)MemberIvana Matelic
HU - HungaryMemberÁgnes Zita Hajdú 
HU - HungaryAlternateCecilia Kurdi 
IE - IrelandMemberClaire Temple
IS - IcelandMemberAgnes Engilráð Scheving 
IS - IcelandAlternateUnnur Ingólfsdóttir
IT - ItalyMemberSandra Petraglia
IT - ItalyAlternateDiego Alejandro Dri
LI - LiechtensteinMemberVlasta Zavadova
LT - LithuaniaMemberArūnas Vaitkevičius 
LT - LithuaniaAlternateEglė Daniulevičiūtė 
LU - LuxembourgMemberEdwige Chokoté
LU - LuxembourgAlternateDounia Bouzid
LV - LatviaMemberJana Migliniece
LV - LatviaAlternateVita Berzina 
MT - MaltaMemberJohn Joseph Borg
MT - MaltaAlternateBenjamin Micallef
NL - NetherlandsVice-Chair/MemberMonique Al
NL - NetherlandsAlternatePaula Vossebeld
NO - NorwayMemberIngvild Aaløkken 
NO - NorwayAlternateIngvild Løberg Tangen 
PL - PolandMemberEwa Ołdak 
PL - PolandAlternateAgnieszka Dzierwa
PT - PortugalMemberJoel Passarinho
PT - PortugalAlternateSusana Marques
RO - RomaniaMemberMirela Vîță 
RO - RomaniaAlternateSilviu Istrate 
SE - SwedenMemberGunilla Andrew-Nielsen 
SE - SwedenAlternateAnn Marie Janson Lang
SI - SloveniaMemberGaja Lesničar Pučko 
SI - SloveniaAlternateJurij Žel
SK - SlovakiaMemberJana Grobarčík Balleková

 

CTCG Contact

Contact Point

E-mail: ctcgnoSpam@noSpamhmanoSpam.eu

 

CTCG Activities and achievements

 

Patients Involvement

Patient involvement, through patient organizations or patient’ representatives, has gained a more prominent role in the landscape of clinical trials. This is supported by recent published recommendations, such as the WHO Best Practice for conduct of Clinical Trials, that states: ‘Patients and communities should be engaged to help to provide valuable contributions to the design and execution of clinical trials and interpretation of their results and hence enable effective measures to protect research participants’ rights.’1 The CTCG acknowledges this, and started a project in the summer of 2024, with the main objective to foster patient involvement in the design of clinical trials. To reach this goal, several different stakeholder groups were approached to provide their view on this topic and to create a clear view on the status of patient involvement in clinical trial design. The stakeholders are patients’ representatives, commercial sponsors and CROs, academics/non-commercial sponsor, members of EU medical research ethics committees, members of National Competent Authorities.  

The collected information from the stakeholders will be used to write a reflection paper that will inform about considerations for fostering patient involvement in the processes of medical-ethical review and to inspire meaningful patient involvement in clinical trial design.  

1 Guidance for best practices for clinical trials. Geneva: World Health Organization; 2024 9 Sept_24049_GCTF_Guidance for best practices for clinical trials 

 

ACT EU pilots on Consolidated Advice to improve clinical trials in Europe 

The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two advice pilots (SAWP/CTCG and Pre-CTA) aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.

The SAWP/CTCG pilot offers developers of medicinal products scientific advice on clinical trials and on requirements for marketing authorization 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.

The Pre-CTA 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 decentralized elements or complex designs, to name a few.

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 optimize clinical trial support in the future.

By strengthening the coordination of the European medicines regulatory network, these advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorization.

For further information please see the guidance for Applicants available at the ACT EU website 

- SAWP/CTCG: Guidance for Applicants

- Pre-CTA: Guidance for Applicants

 

Simultaneous National Scientific Advice (SNSA)

SNSA is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one NCA at the same time. The format is intended to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicine Agencies (HMA), phase 2 of the SNSA pilot will run for a two-year period until the end of 2024.

In conjunction with the ACT-EU initiative, this phase of the SNSA pilot will have a specific focus on scientific advice to facilitate clinical trials (CT) within Europe. It will facilitate sponsors / developers to obtain clinical trial-related national scientific advice from National Competent Authorities (NCA) in Member States (MS) where they intend to perform clinical trials. The experience gained during the SNSA pilot will be used to further develop the process and the provision of clinical trial-related advice as part of ACT EU Priority Action 7 (ACT EU PA7).

The following are examples of scenarios where developers may choose to seek SNSA:

  • In preparation for clinical trials (CT) applications to be performed in more than one MS. Where during the SNSA the involved NCAs agree that the questions raised would benefit from discussions at the Clinical Trial Coordination Group (CTCG) level, it is also possible to obtain CTCG-coordinated clinical trial expert feedback as part of the SNSA procedure.
  • Prior to applying for funding grants to support non-commercial clinical trials (academic researchers).
  • To inform the early-stage development of innovative products for which clinical trials are planned, e.g. phase I/II clinical trials, especially where there is limited existing regulatory guidance. EMA scientific advice should continue to be used for scientific advice related to the suitability of the proposed clinical development to support a centralized marketing authorisation application.
  • Prior to clinical trials intended to facilitate repurposing of authorised medicinal products e.g. to support new innovative therapeutic indications.

More detailed information on how to apply for SNSA and additional documents and information can be found at Heads of Medicines Agencies: EU-Innovation Network (EU-IN) (hma.eu) (search for SNSA).

In order to clarify the scope of scientific advice activities, ACT EU mapped information on voluntary procedures available within the European medicines regulatory network: Accelerating Clinical Trials in the EU (ACT EU) | European Medicines Agency (europa.eu) (look at PA 7).

 

Decentralised Clinical Trials (EU DCT)

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.

The EU Decentralised Clinical Trials (EU DCT) project | pdf

CTCG Key documents list

TEMPLATES 

COVER LETTERS and RFI RESPONSE

CTCG provides the following templates, to be used in different situations:

Initial Applications

Substantial Modification (SM)

Request of Further Information

Transitional Trials

First SM: document requirements after transition

GUIDANCE

Frequently asked questions related to Clinical trials submitted under the Regulation EU 536/2014

Guide for Change of Trial Sponsor

CTCG Best practice Seasonal Vaccines for sponsor

Fees for clinical trials submitted under CTR 

CTIS Guidance

Complex Clinical Trials

Clinical Trial Safety

GLP Principles

In order to avoid rejection of clinical trial applications, sponsors should ensure that all pivotal non-clinical safety studies follow the Good Laboratory Practice Recommendation paper provided below. Importantly, all pivotal non-clinical safety studies performed outside OECD or fully MAD adherent countries should fulfil the requirement of a successful GLP inspection (i.e. a full test facility inspection or inspection of the study submitted as part of the dossier) by an EU GLP compliance monitoring authority, within three years before or after the final study report date. This information should be provided in the application dossier, filling in the template table provided below. For additional information about OECD or fully MAD countries, please contact the national contact point of the MS.        

Other Guidance and Q&A Documents

 

 

CTCG News and events

CTCG Workplan 2024-2025

The CTCG has officially published its work plan for the 2024–2025 period, outlining key objectives, initiatives, and strategic priorities for the coming year. You can access the full document at the following link.

Meeting schedule for 2025

DateDate of the weekLocation
08-09 January 2025Wednesday & ThursdayVirtual
06-07 February 2025Thursday & FridayEMA, room 0A
06-07 March 2025Thursday & FridayVirtual
07-08 April 2025Monday & TuesdayEMA, room 1A
12-13 May 2025Monday & TuesdayVirtual
02-03 July 2025Wednesday & ThursdayEMA, room 0A
29-30 September 2025Monday & TuesdayCopenhagen [DK presidency]
16-17 October 2025Monday & TuesdayVirtual
03-04 November 2025Monday & TuesdayEMA, room 0A
02-03 December 2025Tuesday & WednesdayVirtual

 

SAFE CT

SAFE CT - Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials

Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) | pdf

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 management phase and will run for 36 months (with a retrospective start date from 01/05/2022 to 30/04/2025).
 

First Annual SAFE CT Safety Assessor Event

The first Annual SAFE-CT Safety Assessor Event was held in Amsterdam at the offices of the EMA on 30-31 January. The event included plenary sessions from external experts in medicines regulation and pharmacovigilance as well as in paediatric oncology and in paediatric clinical trials in addition to workshops on Annual Safety Report (ASR) and Suspected Unexpected Serious Adverse Reaction Report (SUSAR) assessment. The event was attended by 52 participants from 26 countries and it was the first of 3 such events planned for the lifecycle of the Joint Action, the focus of which is the exchange of experience and knowledge and the fostering of cooperation in safety assessment across the network. Further information on the event is highlighted in the 13th edition of the 'Clinical Trials highlights' newsletter.
 

Face-to-Face Safety Assessor Round Table

In May 2023, the first face-to-face safety roundtable meeting was held in Bonn, Germany. This event, which was organised under Work Package 4 “Sustainability”, brought together 69 participants from 23 Member States. The event was part of the regular suite of virtual meetings run under WP4, whose aim is to build and maintain an expert community network to improve existing procedures, exchange experience and discuss scientific issues relating to pharmacovigilance in clinical trials.

 

Second Annual SAFE CT Safety Assessor Event

On 15-16 January 2024 EMA hosted the second annual safety assessors event within EU4Health Joint Action Safety Assessment Cooperation and Facilitated Conduct of Clinicall Trials (SAFE CT). 54 safety assessors from 24 different member states participated in the training on safety surveillance of clinical trials. The training included lectures from industry and regulatory authorities on monitoring procedures as well as dedicated workshops rellated to decision making in safety surveillance. Participants also had an opportunity to network within the regulatory community.

A final Safety event is planned for January 2025.

 

Second Face-to-Face Safety Assessor Round Table

The 2nd ‘SAFE CT - Face to Face Roundtable Meeting’ took place from June 5 to 6, 2024 at the BfArM in Bonn.

The network and training event included plenary lectures on signal management and PSUR assessment in Pharmacovigilance (PV) of marketed products by regulatory authorities as well as insight into clinical research in neurodegenerative disease by a dedicated Research Organisation. In addition, a hands-on workshop focussed on signal management in clinical trials.

Approximately 53 participants from 21 Member States shared experiences in assessment and the coordinated processes to further harmonise and optimise these procedures in safety surveillance (PV) in clinical trials.

The event was another key building block in ensuring that the EU/EEA remains an important location for conducting safe clinical trials in the future.
 


Joint Annual SAFE-CT Safety Assessor Event and Face-2-Face Safety Assessor Round Table Event

A joint annual SAFE-CT safety assessor event and Face-2-Face safety assessor round table was held in Amsterdam at the offices of the EMA on 31st March to 2nd April 2025.

The first day of the meeting was dedicated to social activities, including a guided tour at the Rijksmuseum and a dinner, which helped participants network before the meeting.

The second day began with discussions on FIH trials, where representatives from a CRO and the Ethics Commission from Leiden explained their processes. This was followed by breakout sessions, allowing participants to gain hands-on experience in assessing SUSARs and share their practices.

In the afternoon, Elena Prokofyeva (FAMHP, Belgium) introduced the use of AI in clinical drug development, focusing on safety and PV. She also shared the Belgian Federal Medicines Agency's experience with AI integration into their workflow. The session concluded with a survey on AI knowledge and use, followed by a fruitful discussion on current experiences.

The meeting was enriched by three excellent presentations: two from pharmaceutical companies (Minhaj Obeidullah, Novartis and Claudia Lehmann, Boehringer Ingelheim) and one from the EMA (Joaquim Berenguer Jornet). They shared their experiences on integrating AI into their workflows, expressing both concerns and enthusiasm about AI's potential impact. The EMA's journey in implementing AI was particularly insightful.

Finally, the presenters held a panel discussion on AI regulation, future perspectives, and considerations for the future of AI.
 


Safe-CT Project Extension

The Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) Steering Committee  are delighted to announce the extension of the project for 1 year, from April 2025 to April 2026.  The amendment to extend the project duration was approved by the European Commission on (24th April 2025). The project will continue to support the objectives of Joint Action (JA)12 in fostering cooperation and harmonisation of safety assessment for clinical trials within the European Union

 The Clinical Trial Regulation and Implementing regulation which came into force on 31 January 2022 introduced the concept of safety cooperation and work-sharing among Member States.

Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (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 Member States. 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.