Comprehending ICH M7(R2) Guidance on DNA Reactive Impurities for Pharmaceuticals
Introduction
In the pharmaceutical arena, the assurance of patient safety is of prime importance. Moreover, the ICH guidelines highlight patient safety by upholding a harmonized approach to be followed by countries/ regions. One such pivotal guideline is ‘ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk’ which is detailed in the blog ahead. Furthermore, the blog uncovers its implications for the pharmaceutical landscape, and glimpses into the future it heralds for drug safety.