IGBA Welcomes update to ICH M7 on Assessment and Control of Nitrosamine Impurities (June 2024)
The International Generic and Biosimilar Medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its decision to develop an Addendum to the ICH M7 Guideline on Assessment and Control of DNA Reactive (mutagenic) impurities, to incorporate the latest scientific advancements supporting the safety assessment and control of nitrosamine impurities into internationally harmonized guidance.