Amendments to Guideline for Good Clinical Practice published

Amendments to Guideline for Good Clinical Practice published

The State Agency of Medicines informs that the amendments to Guideline for Good Clinical Practice (GCP) have been published on the website of the International Council for Harmonisation (ICH) www.ICH.org. The Guideline for GCP with integrated amendments is available in English (PDF file).

The Guideline for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.

This Guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.