The ICH also noted “significant milestones” had been reached on advancing other guidelines, including the adoption of the ICH M12 guideline on “Drug Interaction Studies” and supporting M12 questions and answers (Q&As) and the release of a Step 2 ICH M14 guidance on the principles for planning, designing and analyzing pharmacoepidemiologic studies that use RWD for assessing the safety of medicines (RELATED: ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance on RWD 20, Regulatory Focus 28 May 2024).
Another milestone was the release of the ICH E2D(R1) draft guideline which harmonizes post-market safety reporting requirements as a Step 2 in February 2023 (RELATED: ICH consults on revised post-approval safety guideline that accounts for digital platforms 5, Regulatory Focus 16 February 2024).
