International – ICH Updates After Singapore Assembly Meeting

The International Council for Harmonisation (ICH) on Wednesday provided an update on some of the milestones achieved following the ICH Assembly meeting in Singapore earlier this month.

Guidelines

During the meeting, the ICH Assembly adopted several guidelines for Step 4 of the ICH process, while several working groups advanced early stage efforts toward the development of new topics and upcoming revisions to existing guidelines.

The newly adopted guidelines include Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle ManagementE9(R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses and M9: Biopharmaceutics Classification System-Based Biowaivers.

ICH called the adoption of the Q12 guideline “particularly noteworthy,” and said that it “aims to promote innovation and continual improvement in the pharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments.”…