Developing Norms and Standards

WHO has played a key role for over 70 years in establishing the WHO International Biological Reference Materials and in developing Norms and Standards (WHO Guidelines and Recommendations) on the production and control of biological products and technologies.

The norms and standards are developed by WHO and the WHO Expert Committee on Biological Standardization (ECBS) in close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide. Their establishment is therefore based on international consensus resulting from wide scientific consultation.

The norms and standards are intended to assist WHO Member States in ensuring consistent quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide.