At Step 5 of the ICH process, harmonised ICH Guidelines are implemented by ICH Regulatory Members and Observers within their respective country/region. This is in line with the ICH Articles of Association and the aim and intention that all ICH Regulatory Members should implement all ICH Guidelines. For ICH Regulatory Observers, implementation of (certain) ICH Guidelines is a pre-requisite to become an ICH Regulatory Member.
ICH Guidelines are implemented in accordance with the applicable national/local/regional rules, with the stage of implementation of all ICH Guidelines also being dependent on when a Member or Observer has joined ICH.
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. ICH is working to understand the level of implementation and adherence to ICH Guidelines within Regulatory Member and Observer countries/regions and to-date has conducted two ICH-driven independent third party surveys in support of this effort with the results available in the 2019 Project Report and 2021 Project Report. Furthermore, additional analysis of the survey entries were undertaken, including analysis of free text comments received at each survey, with the results of 2021 Survey analysis to be found in the 2021 Free Text Comments Report. In addition to this, the responses with regards to the status of implementation and adherence for 2019 versus 2021 for Tier 2 Guidelines and the consistent cohort of authorities as well as companies were compared and results of the comparative analysis are available in the Consistent Cohort 2019 vs 2021 ICH Study document.
Furthermore, recognising the need to have a common view on different degrees of implementation, ICH has also developed Definitions of terms in the context of the implementation of ICH Guidelines.
Search for the Status of Implementation of ICH Guidelines by ICH Members
Information on the status of implementation of ICH Guidelines by ICH Regulatory Members can be searched via the table below. Please select the relevant topic, Guideline and/or ICH Member to consult the status, date of implementation, as well as to access the reference. You can also download the information in a spreadsheet by clicking on "Download to XLS".
More detailed information on each ICH Guideline is published on the ICH website via the respective ICH Guideline page.