Global norms and standards for biological quality, safety and efficacy.(Biomedicines Update)(Company overview)

WHO Expert Committee on Biological Standardization

Established in 1947, the Expert Committee on Biological Standardization (ECBS) is one of the longest standing World Health Organization (WHO) committees and has overall responsibility for setting written standards and establishing reference preparation materials. Standards developed through the ECBS relate to the production and quality control of safe and effective biological products. They provide guidance for national regulatory authorities and manufacturers and serve as the standard for prequalification of vaccines for supply to countries through international agencies. Reference preparation materials are available from designated WHO laboratories and provide the basis for comparison of materials used in biologicals worldwide.

Members of the ECBS are scientists from national control agencies, academia, research institutes and public health bodies. These scientists act as individual experts and not as representatives of their respective organizations or employers. The decisions and recommendations of the ECBS are based entirely on scientific principles and public health considerations.

The ECBS reports directly to the WHO Executive Board, which is the executive arm of the World Health Assembly. The outcome of each ECBS meeting is subsequently published in a technical report. This report provides updated information on standards for assuring the quality, safety and efficacy of biological products as well as on the establishment of new or updated WHO international standards for designating the activity of biological substances. ECBS technical reports are available at: http://www.who.int/biologicals/publications/trs/en/index.html

Highlights of the 2008 ECBS meeting

Biological medical products such as vaccines, blood products, biotherapeutics and associated diagnostics save lives, reduce suffering and improve health, but only if these products and technologies are of good quality, are safe, effective, available, affordable and properly used. WHO is working with it's Member States to use only biological medicines of assured quality in national health systems. The WHO Expert Committee on Biological Standardization (ECBS) establishes global norms and standards that help define products of assured quality. The ECBS meets annually and their most recent meeting was held in Geneva from 13 to 17 October 2008. During the meeting, 57 agenda items were considered. This was accomplished, as in previous years, by running two parallel tracks, one dedicated to vaccines and selected other biological medicines; one dedicated to blood products and related in vitro diagnostic devices.

The most important outcomes of the 2008 ECBS meeting were: