International – ICH details milestones reached on guidelines after Athens meeting

The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.

The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee, the MedDRA Management Committee and the ICH Assembly.

The Assembly noted that “significant milestones” were made by several working groups since the last ICH meeting.

One such milestone was the issuance of the revised ICH Q2(R2) as a Step 2 draft guideline in March 2022 on “Validation of Analytical Procedures” that provides guidance on the principles of analytical procedures validation, adding validation principles for near-infrared (NIR)-based analysis and Raman spectroscopy. (RELATED: ICH releases draft guidelines on analytical method development, Regulatory Focus 31 March 2022)…