CTCG Introduction/Overview

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 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, Ph.D. (AGES MEA, Austria) and vice-chair: Greet Musch, Ph.D (FAMHP, Belgium)
  • The mentor of the group at the level of HMA is Xavier De Cuyper (FAMHP, Belgium)

 

CTCG Contact

The secretariat of the group is managed by Italy. The HMA contact is Giovanni Affronti from the Italian Medicines Agency (AIFA).

Contact: ctfg.secretariatnoSpam@noSpamaifa.govnoSpam.it

 

CTCG Activities and achievements

  • Election of chair and vice chair on 15 February 2022

  • Workplan

CTCG Key documents list

Continuing the work of CTFG all the CTFG guidance documents are still applicable until updated under CTCG responsibility:

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)

Guidance

National fees/information

Clinical Trials Safety

 

 

CTCG News and events

CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials | pdf

 


 

Meeting schedule for 2022

03-04/05/2022EMA (virtual)10:00 - 17:00
21-22/06/2022EMA (virtual)10:00 - 17:00
06-07/09/2022EMA (virtual)10:00 - 17:00
25-26/10/2022EMA (virtual)10:00 - 17:00
06-07/12/2022EMA (virtual)10:00 - 17:00