Regulatory Roundup: ICH Steering Committee Approves Revised Guideline for Genotoxicity Testing and Data Interpretation for Medicines
ICH Steering Committee Approves Revised Guideline for Genotoxicity Testing and Data Interpretation for Medicines.
The International Conference on Harmonization (ICH) steering committee and working groups met in Seville, Spain, earlier this month. The groups meet twice annually to discuss, revise, and approve various harmonization guidelines. At the latest meeting, the steering committee approved a revised ICH S2(R1) guideline for genotoxicity testing and data interpretation for medicines intended for human use. The Quality Implementation Working Group (IWG) completed three points-to-consider documents on process validation/process verification, the role of modeling in QbD, and design space. All documents will soon appear on the ICH website. The next meeting will be held in Fukuoka, Japan, in June 2012.
The US Pharmacopeia has developed a memorandum of understanding with the Chilean Pharmacopeia Foundation to help provide the quality and safety of medicines in Chile and the United States. USP has recently established similar partnerships with Russia and the Ukraine.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
