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 representatives

  • 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: Monique Al, PhD (CCMO, Netherlands)
  • The mentor of the group at the level of HMA is Björn Eriksson, MD, PhD (Läkemedelsverket, Sweden)

Member State

Member

AT - Austria

Marianne Lunzer

AT - Austria

Stefan Strasser

BE - Belgium

Anne Lenaers

BE - Belgium

Nele Steens

BG - Bulgaria

Vessela Boudinova

BG - Bulgaria

Ventsislav Iliev

CY - Cyprus

Eleni Georgiadou

CY - Cyprus

Theognosia Patsaledou

CZ - Czech Republic

Eva Hrušková Reinová

CZ - Czech Republic

Jan Nemecek

DE - Germany (BfArM)

Claudia Riedel

DE - Germany (BfArM)

Sarah Heil

DE - Germany (PEI)

Andreas Bonertz

DE - Germany (PEI)

Susanne Lerch

DK - Denmark

Lene Grejs Petersen

DK - Denmark

Pernille Sterling

EE - Estonia

Keiu Heinla

EE - Estonia

Juta Kraav

ES - Spain

Juan Estévez Álamo

ES - Spain

Maria Sanz Ruiz

ES - Spain

Laura Lavin de Juan

FI - Finland

Marita Kailajärvi

FI - Finland

Pirjo Inki

FR - France

Corinne Kiger

FR - France

Stéphane Vignot

GR - Greece

Leonidas Klironomos

HR - Croatia (HALMED)

Ivana Kosier

HR - Croatia (HALMED)

Maja Puklek

HR - Croatia (Miz)

Ivana Grabušić

HR - Croatia (Miz)

Romana Katalinić

HU - Hungary

Dora Földesi

HU - Hungary

Ágnes Zita Hajdú

IE - Ireland

Claire Temple

IE - Ireland

Erin McBride

IS - Iceland

Hjalti Kristinsson

IS - Iceland

Unnur Ingólfsdóttir

IT - Italy

Sandra Petraglia

IT - Italy

Donatella Gramaglia

LI - Liechtenstein

Vlasta Zavadova

LT - Lithuania

Arūnas Vaitkevičius

LT - Lithuania

Eglė Daniulevičiūtė

LU - Luxembourg

Edwige Chokoté

LU - Luxembourg

Dounia Bouzid

LV - Latvia

Jana Migliniece

LV - Latvia

Vita Berzina

MT - Malta

John Joseph Borg

MT - Malta

Benjamin Micallef

NL - Netherlands

Monique Al

NL - Netherlands

Paula Vossebeld

NO - Norway

Ingvild Aaløkken

NO - Norway

Ingvild Løberg Tangen

PL - Poland

Ewa Ołdak

PL - Poland

Agnieszka Dzierwa

PT - Portugal

Joel Passarinho

PT - Portugal

Susana Marques

RO - Romania

Mirela Vîță

RO - Romania

Silviu Istrate

SE - Sweden

Gunilla Andrew-Nielsen

SE - Sweden

Ann Marie Janson Lang

SI - Slovenia

Gaja Lesničar Pučko

SI - Slovenia

Teja Drofelnik

SK - Slovakia

Jana Grobarčík Balleková

CTCG Contact

Contact Point

E-mail: ctcgnoSpam@noSpamhmanoSpam.eu

 

CTCG Activities and achievements

 

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

Guidance

Transitional Trials

In the light of the huge number of Clinical trials to be transitioned to the CTR, the CTCG Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 will be adapted to newly arising problems as needed. Please check the guidance document regularly.
 

CTIS Guidance

  • Best practice guide naming of documents in CTIS | pdf
    CTCG has set up a best practice for the naming of documents in CTIS. The purpose of this naming convention is to provide a harmonised structured overview of the documents in the clinical trial application dossier, in alignment with the document types referred to in the sections of CTR annex I and II. This guide provides instructions on how to use the naming of documents in CTIS and on the use of the EU trial number within documents. CTCG accepts that the CT numbers within the documents uploaded into the system do not include the last 2 digits, so that they do not need to be changed for re-submission. Any feedback on this best practice guide for naming of documents can be sent here.

Complex Clinical Trials

  • 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
  • Submission of complex clinical trials (CCT) in the Clinical Trial Information System (CTIS)
    This Question and Answers document on CCT and CTIS  will give an answer on the most important factors to be considered.
  • Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials | pdf

Clinical Trial Safety

  • CTCG’s developed a Simplified template of Annual Safety Report, April 2023.
    Non-commercial sponsors conducting a single clinical trial on IMPs with a MAH in any of the EU/EEA member states and where the SmPC is used as RSI submitting this simplified ASR based on the ICH-E2F may be appropriate. This template gives detailed instructions on what information is expected and what may be omitted in this setting. The simplified ASR should always be written in English.

Other Guidance and Q&A Documents

 

Historical documents

National fees/information

Clinical Trial Safety

Brexit
UK/EU transition period will end on December 31 2020.
Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU | pdf
 

CTFG Activity Report

Clinical Trials Authorisations (CTAs) - VHP Procedures

COVID-19

CTCG News and events

Newly adopted documents

Meeting schedule for 2023

 

DateDate of the weekLocation
12-13 January 2023Thursday & FridayEMA
13-14 February 2023Monday & TuesdayVirtual
13-14 March 2023Monday & TuesdayVirtual (SE Presidency)
20-21 April 2023Thursday & FridayEMA
15-16 May 2023Monday & TuesdayVirtual
26-27 June 2023Monday & TuesdayVirtual
11-12 September 2023Monday & TuesdayVirtual
25-27 October 2023Wednesday - FridayMadrid (ES Presidency)
13-14 November 2023Monday & TuesdayVirtual
04-05 December 2023Monday & TuesdayEMA

 

Meeting schedule for 2024

 

DateDate of the weekLocation
29-30 January 2024Monday & TuesdayVirtual
05-07 March 2024Tuesday - ThursdayBrussels (BE Presidency)
15-16 April 2024Monday & TuesdayVirtual
22-23 May 2024Wednesday & ThursdayEMA
18-19 June 2024Tuesday & WednesdayVirtual
09-10 September 2024Monday & TuesdayEMA
07-08 October 2024Monday & TuesdayVirtual
04-05 November 2024Monday & TuesdayEMA
02-03 December 2024Monday & TuesdayVirtual

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.