ICH Previews Revised GCP Guidance
The International Council on Harmonization (ICH) provided a preview last week of the planned revision of its good clinical practice (GCP) guideline, publishing a list of 12 principles that will form the basis of the ICH E6 guideline.
Most of the principles represent long-standing GCP tenets, but the list also signals the addition to ICH E6 of the topics of quality by design, critical-to-quality factors and reliability of digitally collected data.
ICH said it will publish ICH E6 in draft form next month — the second revision of the major guideline in the past five years after not publishing any revisions for 20 years (CenterWatch Weekly, Nov. 16, 2020).
Meanwhile, the council is making progress on its new guidance on adaptive clinical trials, ICH E20, which it plans to release in draft form by November. The FDA and Health Canada will hold a joint public meeting on May 14 to discuss ICH developments.
Read the statement of ICH E6 principles here: https://bit.ly/3sB3BFS.