Expert group on clinical trials (CTEG) - Main contents
Details
Abbreviation: CTEG
Policy Area: Public Health
Lead DG: DG Health and Food Safety
Type: Informal
Scope: Limited
Mission: CTEG serves as a forum to national experts to discuss technical regulatory issues on clinical trials on medicinal products for human use. CTEG supports the Commission and the Clinical Trials Coordination and Advisory Group (CTAG) with the implementation of the Clinical Trials Regulation (EU) No 536/2014 and its implementing acts.
Task: Provides expertise to the Commission when preparing implementing measures, i.e. before the Commission submits these draft measures to a comitology committee
Contact: -
Publication in RegExp: 14/06/2006
Creating Act: -
Last updated: 02/03/2023
Additional Information
Activity report: Meeting 18 February 2010 - AD HOC GROUP FOR THE DEVELOPMENT OF IMPLEMENTING GUIDELINES FOR THE “CLINICAL TRIALS DIRECTIVE” 2001/20/EC
10_02_18_Minutes FINAL_Redacted.pdf (approx. 227 kb)
10_02_18_ Agenda.pdf (approx. 201 kb)
Activity report: Meeting 11 May 2010 - AD HOC GROUP FOR THE DEVELOPMENT OF IMPLEMENTING GUIDELINES FOR THE “CLINICAL TRIALS DIRECTIVE” 2001/20/EC
10_05_11_Final Minutes_Redacted.pdf (approx. 220 kb)
10_05_11_Agenda.pdf (approx. 152 kb)
Activity report: Meeting 22 July 2010 - AD HOC GROUP FOR THE DEVELOPMENT OF IMPLEMENTING GUIDELINES FOR THE “CLINICAL TRIALS DIRECTIVE” 2001/20/EC
10_07_22_Final_Minutes_Redacted.pdf (approx. 185 kb)
10_07_22_Agenda.pdf (approx. 152 kb)
Activity report: Meeting 13 October 2010 - AD HOC GROUP FOR THE DEVELOPMENT OF IMPLEMENTING GUIDELINES FOR THE “CLINICAL TRIALS DIRECTIVE” 2001/20/EC
10_10_13_Minutes final_Redacted.pdf (approx. 190 kb)
10_10_13_Agenda.pdf (approx. 146 kb)
Activity report: Meeting - 25 February 2011
2011 February Agenda.pdf (approx. 149 kb)
2011 February final minutes.pdf (approx. 189 kb)
Activity report: Meeting - 1 April 2011
2011 April Agenda.pdf (approx. 152 kb)
2011 April final minutes.doc (approx. 87 kb)
Activity report: Meeting - 13 July 2011
2011 July Agenda.pdf (approx. 151 kb)
2011 July final minutes.pdf (approx. 184 kb)
Activity report: Meeting - 6 October 2011
2011 October Agenda.pdf (approx. 148 kb)
2011 October final minutes.pdf (approx. 240 kb)
Activity report: Meeting - 7 February 2012
2012 February Agenda.pdf (approx. 126 kb)
2012 February final Minutes.pdf (approx. 159 kb)
Activity report: Meeting - 18 December 2012
2012 December Agenda.pdf (approx. 178 kb)
2012 December final minutes.pdf (approx. 402 kb)
Activity report: Meeting - 8 March 2013 - Sub-group "EU Clinical Trials Communication System"
Activity report: Meeting - 30 April 2013
2013 April Agenda.pdf (approx. 182 kb)
2013 April final minutes.pdf (approx. 295 kb)
Activity report: Meeting - 25 October 2013 - Sub-group "EU Clinical Trials Communication System"
Activity report: Meeting - 6 June 2014
2014_06_06 Agenda.pdf (approx. 70 kb)
2014_06_06 minutes.pdf (approx. 193 kb)
Activity report: Meeting - 1 December 2014
2014_1_12_agenda.pdf (approx. 27 kb)
2014_1_12_Minutes.pdf (approx. 190 kb)
Activity report: Meeting - 9 March 2015
2015_03_09 agenda.pdf (approx. 108 kb)
2015_03_09 Minutes.pdf (approx. 408 kb)
Activity report: Meeting - 20 April 2015
2015_04_20 agenda.pdf (approx. 109 kb)
2015_04_20 minutes.pdf (approx. 232 kb)
Activity report: Meeting - 25 September 2015
2015_09_25 agenda.pdf (approx. 71 kb)
2015_09_25 minutes.pdf (approx. 302 kb)
Activity report: Meeting - 23 November 2015
2015_11_23 agenda.pdf (approx. 151 kb)
2015_11_23 minutes.pdf (approx. 407 kb)
Activity report: Meeting - 8 February 2016
2016_02_08 agenda.pdf (approx. 140 kb)
2016_02_08 minutes.pdf (approx. 507 kb)
Activity report: Meeting - 4 April 2016
2016_04_04 agenda.pdf (approx. 44 kb)
2016_04_04 Minutes.pdf (approx. 258 kb)
Activity report: Meeting - 30 June 2016
2016_30_06_Agenda.pdf (approx. 73 kb)
2016_30_06 minutes.pdf (approx. 216 kb)
Activity report: Meeting - 26 January 2017
Invitation.pdf (approx. 58 kb)
Agenda.pdf (approx. 26 kb)
2017 Janurary final minutes.pdf (approx. 161 kb)
Activity report: Meeting - 25 April 2017
2017_25_04_draft_agenda final.pdf (approx. 86 kb)
2017 April Final minutes.pdf (approx. 227 kb)
Activity report: Meeting - 28-29 June 2017
2017_28_29_06_draft_agenda.pdf (approx. 150 kb)
2017 June final MINUTES.pdf (approx. 150 kb)
Activity report: Meeting - 18-19 September 2017
01 2017_18_09_draft_agendav2.pdf (approx. 86 kb)
2017 September final minutes.pdf (approx. 377 kb)
Activity report: Meeting - 7 November 2017
Agenda.pdf (approx. 30 kb)
2017 November final minutes.pdf (approx. 137 kb)
Activity report: Meeting - 7 December 2017
2017_07_12draft_agenda.pdf (approx. 150 kb)
2017 December final minutes.pdf (approx. 381 kb)
Activity report: Meeting - 19 February 2018
2018 February Agenda.pdf (approx. 85 kb)
2018 February final minutes.pdf (approx. 210 kb)
Selection procedure: The participants to the group are sent by the national competent authorities and the Ethics Committees of each Member State. According to the "Clinical Trials Directive" 2001/20/EC (Articles 8, 9(8), 11(3), 15(5), 18) the Commission is under an obligation to draw up detailed guidance on the application of the "Clinical Trials Directive". According to these articles, this has to be done in consultation with Member States.The members are the national competent authorities and the ethics committees in charge of applying the "Clinical Trials Directive" 2001/20/EC. These are experts in the regulation of clinical trials and in the application of the "Clinical Trials Directive" 2001/20/EC in daily practice.
Rules of procedure: The group serves as discussion forum of experts. There are no written rules of procedure.
Other: This expert group supports the Commission in the implementation of Directive 2001/20/EC on clinical trials, and other related regulatory activities of the Commission.
https://health.ec.europa.eu/medicinal-products/clinical-trials_en
Subgroups
No Subgroups assigned to this group.