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On April 19, ICH released the draft of the E6(R3) Clinical Trial Management Practice (GCP) general principles, which will form the basis of its revised GCP guidelines.
The ICH E6(R3) expert working group is revising the E6(R2) GCP guidelines with a view to applying the GCP principles to the increasingly diversified test types and data sources used to support regulatory and healthcare-related drug decisions.
Provide flexibility to facilitate the use of technological innovation in clinical trials.
Since the revision of ICH E6(R2) may have a broad and significant impact on the clinical trial methods in ICH member regions and other regions, the ICH Management Committee stated that it will issue “the latest draft principles in progress” to improve transparency and A common understanding of the issues involved.
ICH explained that the updated principles are "interdependent and should be considered as a whole to ensure ethical trial behavior, participant safety, and reliable clinical trial results.
The draft principle document lists 12 main considerations, covering many issues, from ethical considerations, informed consent, quality considerations to the recording of test results.
The United States-based Association of Clinical Research Organizations (ACRO) welcomed the draft principles, especially the “concerns about innovative digital health technologies and ensuring that the principles of clinical trial execution are synchronized with technological development”.
The draft document has not yet been publicly consulted.
GCP refurbishment
The last revision of the ICH E6(R2) guideline was in 2016.
When the revision of E6(R2) is completed, the following documents will be available:
The overall GCP principle document;
Appendix 1, focusing on interventional clinical trials;
Appendix 2, will outline other considerations for non-traditional interventional clinical trials.
The principle document and Appendix 1 are being developed at the same time.