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Medicines & Healthcare products Regulatory Agency
The National Institute for Biological Standards and Control

Confidence in biological medicines

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Mission and values

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.

Vision

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.

Values

In pursuing our vision we will strive to be:

  • innovative
  • proactive
  • impartial
  • evidence-based
  • open
  • trustworthy 

NIBSC mission

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 National Control Laboratory for Biological Medicines, working closely with MHRA and carrying out Independent Control Testing of batches of biological medicines as required by UK 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:

  • pandemic influenza preparation
  • development and safe implementation of new vaccines
  • stem cell research
  • CJD risks and safety of clinical trials

The NIBSC mission is underpinned by 5 key strategic aims

  1. To fulfill 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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