Status of ICH Guidelines implementation by ICH Regulatory Members

On 1 November 2019 a report of monitoring the adequacy of implementation and adherence to ICH guidelines available on the ICH website

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 in 2019 conducted an ICH-driven independent third-party survey 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.

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