What GCP guideline provides the basis for international harmonization?

The ICH E6 (R2) Guideline for Good Clinical Practice provides the basis for international harmonization in clinical trials. This guideline was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which aims to harmonize regulations and standards across different regions to improve the efficiency of the drug development process.

It establishes a unified framework that is recognized and accepted by regulatory authorities in the U.S., Europe, and Japan, thereby facilitating global collaboration and minimizing the discrepancies in clinical trial practices worldwide. The guideline emphasizes the importance of protecting trial participants, ensuring data integrity, and adherence to ethical standards, which are crucial components of Good Clinical Practice.

In contrast, while FDA 21 CFR represents U.S. federal regulations governing clinical trials, it does not create a harmonized approach for international studies on its own. ISO 9001 is a standard related to quality management systems, which is broader and not specific to clinical trials. The GCP Task Force Recommendations, while valuable, do not provide the comprehensive framework that ICH E6 (R2) does for achieving international harmonization.