ICH Seeks Public Input on New Guidelines for Drug Impurities from Leachables

The International Council for Harmonisation (ICH) has opened a public consultation on its draft guidelines for managing drug impurities caused by leachables. These guidelines aim to ensure patient safety and product quality by assessing and controlling organic leachables in medications, including new treatments like cell and gene therapies. The draft, known as ICH Q3E, builds on existing ICH guidelines that address other types of impurities, such as residual solvents, elemental impurities, and DNA-reactive impurities. The new guidelines follow risk management principles from ICH Q9 and include details on material characterization and process understanding. The ICH expects these guidelines to help pharmaceutical companies with their product approvals, including those involving drug delivery devices. The ICH also recently updated guidelines on electronic safety reports (ICH E2B(R3)) and adaptive clinical trial designs (ICH E20), which are already being implemented by regulatory agencies in the US, EU, and UK. The ICH provides technical guidance on pharmaceutical quality, safety, and effectiveness for medicines intended for human use.

Scroll to Top