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The ICH Q14 draft Guideline on Analytical Procedure Development reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.
The ICH E9(R1) EWG finalised the development of the Training Material for Estimands and Sensitivity Analysis in Clinical Trials.
This leaflet provides a brief overview of ICH’s mission, structure and current work.
The International Council for Harmonisation (ICH) met virtually on 17 and 18 November. The Assembly meeting was preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.
This publication was developed to commemorate the ICH 30th Anniversary. It provides an overview of ICH’s history and current work, as well as views of different stakeholders on how ICH has contributed to better health and ICH’s future directions in the next 10 years.
Following the conclusion of the ICH E6(R3) EWG’s Public Web Conference on Good Clinical Practice in May 2021, a Report is available to download and a Video Presentation has been published on the ICH YouTube channel.
This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.
The ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH process on 6 October 2021 and now enters the public consultation period.