ICH S6 (Biotechnology Products)

ICH S6 is an international guideline developed by the International Council for Harmonisation (ICH) that outlines the testing and development processes for biotechnology products, such as biologics and therapeutic proteins. It provides recommendations on safety, quality, and efficacy assessments to ensure that these products are safe for human use. The aim is to harmonize regulatory requirements across different countries, making it easier for companies to bring innovative treatments to market while maintaining high standards for patient safety. This guideline supports the advancement of biotechnology in medicine.