National Institute for Biological Standards and Control

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The misson of NIBSC is to play a major national and international role in assuring the quality of biological medicines through product testing, developing standards and reference materials and carrying out applied research.   It supports health policy development and implementation through provision of expert evidence-based advice and technical support and is an important component of the Department of Health’s risk management strategy for public health.

It is designated as the UK’s Official Medicines Control Laboratory (OMCL) for Biological Medicines, working closely with the MHRA and operating within the European regulatory network to carry out independent official batch release testing of certain types of product as required by EU law.  It is also the leading WHO International Laboratory for Biological Standards and a WHO collaborating centre for polio, influenza and HIV.   It occupies a unique international position at the interface between product manufacturers, regulators, policy makers and leading edge academic research.  It serves a broad range of customers and stakeholders in the UK and abroad and has a high worldwide reputation for independence, integrity and scientific excellence.  

 

The Institute’s role is increasing in importance as the number and complexity of biological medicines grows, and public expectation of the safety of medicines rises. Its work supports not only public health protection, but also wealth creation, by facilitating the development of new products and classes of medicine for unmet clinical needs. Its work continues to be at the heart of many highly significant public health issues such as pandemic influenza preparation, development and safe implementation of new vaccines, stem cell research, vCJD risks and safety of clinical trials.  

 

The NIBSC mission is underpinned by 5 key strategic aims.

 

  1. To fulfil national and international needs for independent product testing in order to safeguard public health.
  2. To maintain world leadership in biological standardisation.
  3. To anticipate and respond to emerging quality and safety issues associated with existing and future biological medicines.
  4. To facilitate the provision of novel biological medicines.
  5. To promote science-led policy making in the field of biological medicine

 



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