International Council for Harmonization

Preparing for the ICH E6 Revisions

Monday, May 1, 2017

In November 2016, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Step 4 of the new Good Clinical Practice (GCP) E6 (R2) guideline. A core principle of E6 (R2) is the integration of quality management (QM) and risk-based approaches to span the entire clinical trial process. The addendum embodies the concept of proactive planning for quality, oversight, preventive action and documentation.

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