International Council for Harmonisation (ICH) E6R3 Annotations

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice is an international guideline that has been developed to facilitate the harmonisation of the quality of the conduct of clinical trials that are intended to be submitted to a regulatory authority in one or more ICH regions to gain a marketing authorisation approval (MAA) for a medicinal product.

In places, ICH E6(R3) includes references to “applicable regulatory requirements” in the relevant ICH region. This document is intended to support those involved in running clinical trials in the UK to comply with ICH E6(R3) by specifying what the applicable regulatory requirements or relevant guidance documents are for the UK.