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Module 1: Lesson 1
ICH and International Harmonization
How the International Council for Harmonisation transformed global drug development by creating unified standards, and why understanding ICH guidelines is essential for anyone working in clinical research.
Learning objectives
By the end of this lesson, you will be able to:
What is ICH?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, universally known as ICH, is a unique organization that brings together regulatory authorities and pharmaceutical industry associations from around the world. Its mission is straightforward but profound: to develop harmonized guidelines that ensure safe, effective, and high-quality medicines are developed and registered in the most efficient manner.
ICH is not a regulatory authority. It does not approve drugs or inspect facilities. It does not enforce compliance. What ICH does is create a forum where experts from different countries can agree on technical and scientific standards. When those standards are adopted by national regulatory authorities, they become binding requirements in those jurisdictions.
The practical effect is that a clinical trial conducted according to ICH guidelines will meet the expectations of regulatory authorities in the United States, Europe, Japan, and dozens of other countries. A sponsor does not need to guess what Japan requires versus what the FDA requires. The requirements are harmonized.
Good Clinical Practice (GCP)
Full course · Clinical Research Foundations