Biologicals

This web site provides information on WHO norms and standards for the production and control of biological medicines and related in vitro diagnostic tests.

Issues & challenges

Vaccine vials (IVB)

Biological medicines such as blood products, vaccines, cell regulators and related in vitro diagnostic tests are life-saving components of every day medical practice worldwide. The quality assurance of such essential biopharmaceutical products and devices raises however particular safety considerations due to the biological nature of the starting materials used, the manufacturing process involved and the tests methods needed to characterize the production consistency. The increasing complexity and sophistication of biological products and technologies and the rapid growth in this field, present an additional considerable challenge for medicines and medical devices regulatory authorities as well as for manufacturers.

WHO norms & standards

WHO has played a key role for over 50 years in establishing the WHO International Biological Reference Preparations and in developing WHO guidelines and recommendations on the production and control of biological products and technologies. These norms and standards are based on wide scientific consultation and on international consensus and are intended to assist WHO Member States in ensuring the consistent quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide. The Organization develops this work through its biological programme and the WHO Expert Committee on Biological Standardization. This also involves close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide.

WHO HPV LabNet - Newsletter 05
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Meeting Report-WHO Workshop in Training Performance of Potency Testing and Lot Release of Human Papillomavirus (HPV) Vaccines
NIBSC, UK, 11-15 May 2009
Download [pdf 136kb]

Further H1N1 specific update of TRS 941, Annex 5
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H1N1 specific-update of TRS 941, Annex 5
Download [pdf 162kb]

ECBS 2008 Outcomes
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Proposed Guidelines: Regulatory Preparedness for Human Pandemic Influenza Vaccines
Download [pdf 690kb]

WHO Workshop on Implementation of Lot Release of Vaccines
8-10 December 2009, Beijing, People's Republic of China