ICH Meeting in Charlotte, USA, 10–15 November 2018

13.12.2018 

The International Council for Harmonisation (ICH) met in Charlotte, USA, from 10 to 15 November 2018. Three years after the reform of the ICH, all organisational changes have now been implemented. The meeting in Charlotte was illustrative of the ICH's steady evolution toward a more global initiative. 

The ICH Assembly now has sixteen (16) Members and twenty-eight (28) Observers. The Assembly welcomed the appointment of NRA, Iran, as the newest Regulatory Observer.

Other appointments at the meeting in Charlotte included the election of Dr. Petra Dörr (Swissmedic, Switzerland) as Assembly Vice-Chair, while Dr. Theresa Mullin (FDA, USA) was re-elected as Chair of the ICH Management Committee. Dr. Nobumasa Nakashima (MHLW/PMDA, Japan) was newly elected Vice-Chair of the ICH Management Committee.

Full details on the membership and the composition of the individual governing bodies are available on the ICH website (www.ich.org). 

Significant progress on new and existing ICH Guidelines
The global orientation of ICH's harmonisation efforts is also reflected in its twenty-five (25) ICH Working Groups, which currently involve over six hundred (600) experts. Thirteen (13) of these Working Groups met in Charlotte to continue their work, including three (3) recently established informal Working Groups and a Discussion Group:

• Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14);
• Continuous manufacturing (Q13);
• Clinical electronic Structured Harmonised Protocol (‘CeSHarP’) (M11);
• Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation (E14/S7B).

The Concept Papers and Business Plans approved at the meeting can be found on the ICH website under the respective Working Groups.

Work on two new topics

• Adaptive Clinical Trials (E20)
• Drug Interaction Studies (M12),

which had already been approved at the meeting in Kobe, is now expected to get under way in mid-2019.

Training as key to successful implementation
The growing number of ICH Members and Observers underlines the importance of training in ensuring a globally consistent approach to the implementation of ICH Guidelines. Consideration of training resources is therefore high on ICH's agenda. Several Working Groups have been tasked with the development of training materials designed to promote the understanding of the new concepts and approaches. 

Understanding the implementation of ICH Guidelines
In parallel, efforts are under way to fully map the implementation of ICH guidelines and adherence by current and future ICH members. Important progress was made in Charlotte in this regard. The Assembly has supported the new terminology with respect to consistent definitions of the degrees of implementation, and acknowledged the progress made in the work on an independent survey aimed at mapping the implementation of ICH Guidelines by its Regulatory Members and Observers. Work on the survey is scheduled for completion in mid-2019; the results are expected in the second half of 2019.

The next ICH meeting will be held in Amsterdam, the Netherlands, from 1 to 6 June 2019. 

The full ICH press release can be found at: