International Council for Harmonisation (ICH) E6R3 Annotationsannotations

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)(ICH)  has produced Guidelinea forseries Goodof international Clinicalguidelines concerning the Practicedesign, isconduct, safety and anreporting international guideline that has been developed to facilitate the harmonisation of the quality of the conduct of clinical trialstrials (the thatEfficacy 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.guidelines).  

In places,places, these ICHguidelines include references E6(R3) includes references to “applicable regulatory requirements”requirements” or insimilar in the relevant ICH region. ThisThe documents documentlinked ison intendedthis page are intended to support those involved in running clinical trials in the UK toto comply complywith the ICH Efficacy withguidelines by ICH E6(R3) by specifying what the applicable regulatory requirements or relevant guidance documents are for the UK.