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.

Information on ICH Guideline implementation for Founding and Standing Regulatory Members is currently published on the ICH website under each ICH Guideline section. Information on ICH Guideline implementation by newer Regulatory Members and Observers will be made available shortly.

Understanding Implementation of ICH Guidelines

Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. ICH is currently working to understand the level of implementation and adherence to ICH Guidelines within Regulatory Member and Observer countries/regions. An ICH-driven independent third party survey is being conducted in support of this effort. 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.