The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a new draft guideline, ICH E6(R3), on May 19, 2023.

This guideline is a revision of the previous ICH E6(R2) and aims to provide a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The ICH E6(R3) guideline is designed to provide a framework for planning, designing, conducting, recording, and reporting trials that involve the participation of human subjects. The guideline ensures the credibility and integrity of the data generated and the protection of trial subjects. The new guideline introduces several changes and updates to the previous version.

Read more here.

References

  1. LinkedIn. (n.d.). https://www.linkedin.com/pulse/recent-changes-ich-good-clinical-practice-gcp-e6r3-guidelines-r/

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