NIBSC

The National Biological Standards Board (NBSB) is a non-departmental public body (NDPB) of the UK government, established, in 1975, as a Statutory Body by Act of Parliament. The Board is responsible for safeguarding and advancing public health by assuring the quality and safety of biologicals, through its management of the National Institute for Biological Standards and Control (NIBSC). NIBSC provides independent testing of biological medicines for the UK market, in particular with vaccines for the UK children's vaccination programme, and operates as an Official Medicines Control Laboratory (OMCL) of the European Union for release of medicines onto the EU market. NIBSC testing of products already released onto the EU market may also be carried out when particular problems arise such as failure of storage conditions or following adverse reactions in patients. NBSB considers it essential to maintain a well balanced and clearly prioritised programme of work on the core functions of NIBSC's work. NIBSC has statutory responsibility for the standardisation and control of biological medicines including vaccines, blood products and other substances which cannot be characterised chemically and which require special testing measures to ensure their safety and efficacy. The Institute is the major World Health Organization Laboratory for the production of International Standards for these products. It is also responsible for the quality testing of batches of these products for use in the UK and Europe. Scientists in the Institute are called upon to advise many bodies including the Department of Health, the MHRA (previously Medicines Control Agency) and the European Medicines Evaluation Agency and are involved in the work of the European Pharmacopoeia. The Institute is also active in research and development related to its statutory functions which amounts to about one third of its overall function. The Institute is divided into several lead biological Divisions which are Bacteriology, Haematology, Immunology and Endocrinology, Virology, Retrovirology and Cell Biology and Imaging. These are supported by other groups such as the Laboratory for Molecular Structure (LMS), Standards Production and Despatch (SPD), Standards Technical development and Computing and Statistics.