NIBSC is a centre of the Medicines and Healthcare Products Regulatory Agency an executive agency of the Department of Health. The Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
As a centre of the agency, we work within the wider agency vision and values.
We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
In pursuing our vision we will strive to be:
NIBSC’s mission 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. we support health policy development and implementation through provision of expert evidence-based advice and technical support and are an important component of the Department of Health’s risk management strategy for public health.
We are designated as the UK’s Official Medicines Control Laboratory (OMCL) for Biological Medicines, working closely with 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.
We are also the leading WHO International Laboratory for Biological Standards and a WHO collaborating centre for polio, influenza and HIV. We occupy a unique international position at the interface between product manufacturers, regulators, policy makers and leading edge academic research.
We serve a broad range of customers and stakeholders in the UK and abroad and has a high worldwide reputation for independence, integrity and scientific excellence.
Our role is increasing in importance as the number and complexity of biological medicines grows, and public expectation of the safety of medicines rises. Our 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.
Our work continues to be at the heart of many significant public health issues such as: