Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

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.

Publications

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WHO Expert Committee on Biological Standardization: eighty-first report

The eighty-first report of the WHO Expert Committee on Biological Standardization presents the deliberations and recommendations arising from the Committee’s...

WHO Expert Committee on Biological Standardization: eightieth report

Eightieth meeting held using a hybrid format in which Committee members and the WHO Secretariat met in person in Geneva from 7 to 11 October 2024 with...

WHO Expert Committee on Biological Standardization: seventy-ninth report

The seventy-ninth meeting of the WHO Expert Committee on Biological Standardization was held virtually from 11 to 14 March 2024. The meeting was opened...