FDA Announces ICH E6(R3) Open Comment Period
06/14/2023
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The U.S. Food and Drug Administration (FDA) announced that the ICH E6(R3) Good Clinical Practice draft guidance is available for comments. This draft includes the GCP Principles and Annex 1, and the ICH Working Group is updating Annex 2.
ICH E6(R3) Draft Principles Published
5/25/2021
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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released draft ICH E6(R3) Principles. ICH E6 Good Clinical Practice (GCP) guideline is the blueprint for clinical trials ensuring subject safety and data quality and it specifies the processes needed for study conduct and documentation to comply with the guideline and regulatory requirements. The last revision occurred in 2016. Since then, clinical trials are increasingly complex and in electronic formats, requiring updates to the GCP guideline to ensure its agility to meet the challenges of modern clinical trials.