The National Institute for Biological Standards Control 14/3/03. By Deirdre Janson-Smith The National Institute for Biological Standards Control (NIBSC) is an independent research institute responsible for standardising and controlling biological substances used in medicine in the UK.

Biological medicines include bacterial and viral vaccines as well as human blood products such as clotting factors and new biotechnology products. These are generally subject to post-licensing regulations and requirements: for example, vaccine and blood products are subject to batch release, and biotechnology products may be subject to additional post-licensing monitoring. NIBSC works closely with MHRA (the Medicines and Healthcare Products Regulatory Authority), which has the formal responsibility for operating these programmes.

At a practical level the MHRA devolves the work to NIBSC, which thus operates as an official medicinal control laboratory. (The batch-testing programme is not separately monitored by MHRA.) Conversely, whilst NIBSC has no formal licensing role, MHRA frequently uses its expertise, both in evaluating scientific aspects of dossiers and on occasion where pre-licensing testing of products is required.

NIBSC plays a wider international role in establishing and distributing International Biological Standards and other biological reference materials, and is an accredited WHO laboratory. It is an autonomous body with a mainly laboratory-based remit, largely directly funded through central government (Department of Health).

Since 2002, NIBSC has been host to the UK Stem Cell Bank, an MRC initiative co-sponsored by BBSRC with the backing of the UK Government.

Image credit: Anthea Sieveking