📊FDA Announces Final Guidance on E6(R3) Good Clinical Practice
E6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "E6(R3) Good Clinical Practice." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled "E6(R3) Good Clinical Practice: Annex 2." Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good clinical practices for conducting clinical trials. Notably, the guidance highlights the importance of quality-by-design, proportionality, and risk-based approaches in conducting clinical trials to ensure safety and reliability of results. The guidance also encourages use of innovative design elements and technology in clinical trials, while avoiding unnecessary complexities. The guidance finalizes the draft guidance of the same title issued on June 7, 2023.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The guidance on "E6(R3) Good Clinical Practice" introduces regulatory requirements for clinical trials, emphasizing modern practices and technological advancements which affect compliance and operational protocols for pharmaceutical companies and businesses conducting clinical research. The implications of quality-by-design and risk-based approaches necessitate adjustments to current trial methodologies.