The revised edition of the ICH E6 guideline, which outlines Good Clinical Practice (GCP) standards for human pharmaceutical trials, has been made available for public consultation by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. This marks the third iteration of the guideline, highlighting the rapid pace of advancement in the field of Medicines Development.

Good Clinical Practice (GCP) serves as a worldwide benchmark for the ethical, scientific, and quality aspects of conducting trials involving human subjects. Adhering to this standard in clinical trials ensures the protection of participants’ rights, safety, and well-being. The guideline also aligns trial conduct with the principles stemming from the Declaration of Helsinki and guarantees the reliability of clinical trial outcomes. The scope of “trial conduct” within this document encompasses activities spanning planning, initiation, execution, documentation, oversight, assessment, analysis, and reporting. The primary aim of the ICH GCP Guideline is to establish a consistent standard that promotes the reciprocal acknowledgment of clinical trial data among ICH member countries and regions, as recognized by relevant regulatory bodies.1

Interested parties are encouraged to provide their feedback and recommendations by September 26, 2023.

Read the revised text here.

References

  1. Research, C. F. D. E. A. (2023). E6(R3) GOOD CLINICAL PRACTICE (GCP). U.S. Food And Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred