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.

• 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.secretariatnoSpam@noSpamaifa.govnoSpam.it

• Election of chair and vice chair on 15 February 2022

• Workplan | pdf

CTCG Workplan | pdf
July 2022

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

• CTFG Activity Report 2008 - 2009 | pdf
• CTFG Activity Report 2010 - 2011 | pdf

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

Guidance

• Complex clinical trials (CCTs) – Questions and answers
  Available 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.

National fees/information

• 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