Major Changes to the International ICH GCP Guidelines

Guideline changes are transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures.

This Addendum is proposed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality.

The guideline is expected to finalize (step 4) and be ready for adoption by November 2016. Changes (as addendum) are integrated directly into the following sections of the parental Guideline: Introduction, 1.11.1, 1.38.1, 1.39, 1.60.1, 2.10, 4.2.5, 4.2.6, 4.9.0, 5.0, 5.0.1, 5.0.2, 5.0.3, 5.0.4, 5.0.5, 5.0.6, 5.0.7, 5.2.1, 5.2.2, 5.5.3 (b), 5.5.3 (h), 5.18.3, 5.18.6 (e), 5.18.7, 5.20.1, 8.1.