ICH’s logo has been designed with a view to representing the letters "I", "C", "H" in a manner which speaks to the benefits of harmonisation for better global health. This has been achieved through the embodiment of the letters in an abstract human form.

Apr 19, 2021 · The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of …

Jan 14, 2025 · The ICH E6(R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. The guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

ICH harmonisation activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision Procedure and Maintenance Procedure, depending on the activity to be undertaken. The development of a new harmonised guideline and its implementation (the formal ICH procedure) involves 5 steps: [9]

These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [ 4 ] they are not statutory in the United States.

The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ensuring the integrity and credibility of ...

Nov 9, 2023 · The objective of this ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the...

The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures participant safety and...